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EPPA Intended Use Statement

This statement is regulatory load-bearing

Every other artefact in this compliance set — the GDPR DPIA, the risk file, the clinical evaluation plan, the software safety classification under IEC 62304 §4.3, the EU MDR Annex VIII Rule 11 classification — is derived from the intended-use statement below. Any modification to the wording in section 2 or section 3 requires re-review by the regulatory lead and may require recomputing the classification and re-issuing the DPIA. See section 11 for the change-control procedure.

1. Document identity

Field Value
Document title EPPA Intended Use Statement
Document ID EPPA-IUS-001
Version 0.1 (draft)
Status Draft — not approved for regulatory submission
Effective date n/a (research use only)
Owner LABIS UCA — Regulatory lead (pending)
Approver Pending — Head of Clinical, Head of Quality, Regulatory lead
Review cadence Annually, and on every change of indication, target population or output

2. Intended use statement (research-use draft)

EPPA is a research-use software tool intended to assist a trained kinesiologist, physiotherapist or postural-medicine physician in the photographic documentation and qualitative analysis of standing posture in adult patients undergoing postural assessment, within the context of an approved clinical research protocol. EPPA is not a medical device and is not intended to be used as the sole or primary basis for any diagnosis, treatment decision, screening conclusion or therapeutic recommendation.

This wording is the only authoritative intended-use statement for EPPA in its current research-use phase. It is mirrored verbatim in the non-device disclaimer (see 91-non-device-disclaimer.md).

3. Intended user

EPPA is intended exclusively for use by qualified clinical professionals. Specifically:

  • A kinesiologist registered with the relevant national or provincial professional body (in Argentina: Colegio de Kinesiólogos provincial; in Spain: Colegio Oficial de Fisioterapeutas; etc.).
  • A physiotherapist with equivalent registration in the jurisdiction of practice.
  • A postural-medicine physician, sports-medicine physician, orthopaedic surgeon or rehabilitation-medicine specialist with general medical registration in the jurisdiction of practice.
  • An academic researcher working under an IRB- or ethics-committee-approved research protocol in postural assessment, biomechanics or related fields.

EPPA is explicitly not intended for direct use by patients, lay users, consumers, fitness coaches, wellness practitioners, chiropractors operating outside a multidisciplinary clinical context, or any other non-clinical user. There is no direct-to-consumer mode and there are no plans to add one within the research-use phase.

4. Target population

EPPA is intended for analysis of standing posture in:

  • Adults aged ≥ 18 years and < 75 years at the time of assessment.
  • Patients who are able to stand unaided for the duration of the photographic capture (approximately 60 to 90 seconds across the four views).
  • Patients who have given informed consent under the applicable national framework (Ley 26.529 in Argentina, GDPR Art. 7 plus national rules in the EU, HIPAA Authorization in the US, etc.).
  • Patients who are not within the contraindication list in section 6 below.

5. Indications for use (research-use phase)

EPPA may be used, within an approved research protocol, for the following non-diagnostic indications:

  1. Photographic documentation of standing posture across four standardised views (anterior, posterior, lateral-left, lateral-right) for the purpose of longitudinal follow-up within a single patient.
  2. Computation of geometric reference values (segment angles, alignment offsets, marker coordinates in image-natural pixel space) for use by the clinician as one input among several in the clinician's own assessment.
  3. Comparative visualisation of two or more capture sessions for the same patient over time.
  4. Generation of a CSV / PDF research report to be appended to the patient's research record. The report carries the non-device disclaimer.

EPPA is not indicated for:

  • Initial diagnosis of any postural, musculoskeletal or neurological condition.
  • Screening of asymptomatic populations.
  • Determination of fitness-for-work, fitness-to-drive, fitness-for-sport, or any other certification with legal or insurance consequences.
  • Pre-operative planning, surgical decision-making, prosthesis specification or orthotic specification.
  • Treatment-outcome measurement in a regulated clinical trial of a separate therapy, unless EPPA-derived measurements are pre-registered in the trial protocol and explicitly flagged as exploratory.

6. Contraindications

EPPA must not be used in the following situations. These contraindications are based on the limitations of photo-based marker analysis, not on patient safety in the traditional sense (the tool is non-invasive and exposes no energy).

# Contraindication Rationale
C1 Severe scoliosis (Cobb angle > 40°) or any other gross trunk deformity Photo-based marker placement is unreliable because spinous processes are displaced from the midline and cannot be reliably palpated or photographed. Reference: SRS guidance on Cobb assessment, which remains radiographic.
C2 Paediatric patients under 12 years of age EPPA has not been validated in skeletally immature populations. Normal reference ranges differ substantially from adults.
C3 Patients with limb amputations (upper or lower) Some marker positions assume bilateral limb symmetry; analysis is invalid.
C4 Patients with rigid spinal orthoses or external fixators in place Surface markers cannot reliably locate underlying anatomical landmarks.
C5 Pregnant patients in the second or third trimester Altered centre of mass and abdominal contour render lateral-view alignment metrics non-comparable to non-pregnant reference values.
C6 Severe obesity (BMI ≥ 40) Surface adiposity may obscure bony landmarks required for marker placement.
C7 Acute injury (within 6 weeks) Antalgic stance distorts measurements. Use is acceptable only if explicitly part of an antalgia-tracking protocol.
C8 Patients unable to maintain a neutral standing position for ≥ 60 seconds without external support Capture quality cannot be guaranteed.
C9 Image quality insufficient (blurred, mis-framed, occluded landmarks, non-orthogonal camera placement) The clinician must reject and re-capture, not analyse.
C10 Patients with active dermatological conditions that would require marker stickers to be placed on broken skin Marker placement must be aborted; freehand marker placement on the image is not equivalent.

7. Required training (gate to use)

Every clinical user of EPPA must complete the following before independent use. This requirement is enforced administratively (LABIS UCA maintains a training register) and will, in Phase 3, be enforced in software via role-gated accounts.

  1. Read the EPPA User Manual (Manual de Uso) in full, in the user's working language. Manual versions are tracked per app release.
  2. Read this Intended Use Statement and the non-device disclaimer in full.
  3. Complete 5 supervised cases under the observation of an EPPA-credentialed clinical supervisor. The supervisor signs off on:
    • correct patient positioning across the four views,
    • correct marker placement (visual agreement against a reference set),
    • correct interpretation of the output (including its limitations).
  4. Pass a marker-placement consistency check against the LABIS MATLAB reference implementation. Intra-rater agreement on a 10-image standard set must be ≥ 0.85 (intra-class correlation coefficient, two-way mixed, absolute agreement) before the user is added to the production register.
  5. Annual re-credentialing — repeat the consistency check yearly to detect drift.

Why MATLAB reference

The MATLAB reference implementation is the original LABIS UCA postural analysis pipeline. EPPA is a re-implementation of that pipeline for clinical field use; therefore inter-system agreement against MATLAB is the natural gold standard during the research-use phase. Once a clinical evaluation file is established under EU MDR Annex XIV, the gold standard will shift to consensus expert annotation.

8. Explicit non-claims

The following statements are expressly NOT made by EPPA, by LABIS UCA, or by any authorised distributor of EPPA during the research-use phase. Any marketing, sales or training material that contradicts the list below is in breach of this Intended Use Statement and must be corrected immediately.

  • EPPA is not a diagnostic device. No output of EPPA is a diagnosis.
  • EPPA is not a screening tool. It is not validated to identify asymptomatic individuals at risk for any condition.
  • EPPA is not a treatment-decision tool. No EPPA output may be used as the sole or primary basis for prescribing, withholding, modifying or terminating any therapy.
  • EPPA is not validated for paediatric use (see contraindication C2).
  • EPPA does not provide a Cobb angle, nor any other radiographic measure. Cobb assessment remains the province of radiography or EOS imaging.
  • EPPA is not interoperable with PACS / EHR systems in the research-use phase. There is no DICOM modality worklist support and no HL7 FHIR DiagnosticReport export. (Roadmap: 40-dicom-fhir-interop.md.)
  • EPPA has not been cleared by the FDA, CE-marked by a notified body, nor registered with ANMAT, ANVISA or BfArM. It is not a medical device in any jurisdiction.
  • EPPA does not store or transmit personal health information in any HIPAA-Covered-Entity capacity until a BAA-backed deployment is established (see 31-hipaa-readiness.md (planned)).

9. Mapping to regulatory frameworks

The wording in sections 2 to 8 has been drafted such that, at the moment of future market placement, the intended-use statement can be re-issued as a device-grade IFU (Instructions For Use) with the following mappings:

Regulation / standard Section / requirement Where covered in this doc
EU MDR Annex I §23.4(a) — IFU shall contain "intended purpose" §23.4(a) Section 2
EU MDR Annex I §23.4(c) — "intended patient population" §23.4(c) Section 4
EU MDR Annex I §23.4(d) — "intended user" §23.4(d) Section 3
EU MDR Annex I §23.4(f) — "contraindications" §23.4(f) Section 6
EU MDR Annex I §23.4(g) — "warnings or precautions" §23.4(g) Sections 6 and 8
IEC 62304 §5.1.1 — software development planning, intended use input §5.1.1 This entire document
ISO 14971 §4.2 — "intended use and reasonably foreseeable misuse" §4.2 Sections 2, 5 and 8
21 CFR 801.4 — meaning of "intended use" 801.4 Sections 2 and 8
21 CFR 820.30(c) — design inputs derived from intended use 820.30(c) Sections 2 to 6
GDPR Art. 35(7)(a) — DPIA "systematic description of the processing operations and the purposes of the processing" Art. 35(7)(a) Sections 2, 4 and 5; cross-referenced in 30-gdpr-dpia.md

10. Reasonably foreseeable misuse

Pursuant to ISO 14971 §4.2, the following misuse scenarios have been identified and are explicitly out of scope. They feed the risk-management file (planned at 12-iso-14971-risk.md):

  1. Use by an untrained user. Mitigation: account-gated access in Phase 3; in the research-use phase, controlled distribution.
  2. Use on a paediatric patient. Mitigation: contraindication C2 in the UI, training, and a planned soft-block on date-of-birth at intake.
  3. Use of the CSV / PDF output in a legal or insurance proceeding. Mitigation: every export carries the non-device disclaimer in the header (see 91-non-device-disclaimer.md).
  4. Use on a smartphone with insufficient camera calibration. Mitigation: the User Manual specifies camera distance, height, lighting, and orthogonal placement.
  5. Use of the output to justify a surgical or pharmacological decision. Mitigation: explicit non-claim in section 8.

11. Versioning and change control

Any change to sections 2 ("intended use"), 3 ("intended user"), 4 ("target population"), 5 ("indications"), 6 ("contraindications") or 8 ("non-claims") of this document is a regulatory change and must trigger:

  1. A new version number (semver-style: MAJOR for any change to claims; MINOR for editorial change to surrounding sections; PATCH for typographical correction only).
  2. Re-review and re-sign-off by Head of Clinical, Head of Quality and the Regulatory lead.
  3. Re-assessment of the EU MDR Rule 11 classification (in 10-eu-mdr-saMD-classification.md (planned)).
  4. Re-assessment of the IEC 62304 software safety class.
  5. Re-issue of the GDPR DPIA insofar as the change affects the data subjects, the data categories, or the processing purposes.
  6. Update of the in-product disclaimer text if section 2 or section 8 changed.
  7. Communication to all credentialed users via email and in-product banner.

Changes purely to sections 1, 7, 9, 10 and 11 may be issued as MINOR or PATCH without re-classification, but still require sign-off.

Version history is maintained in the project's regulatory log (see compliance/_changelog.md (planned)).

References