Instructions for Use — DRAFT
Status: draft. Not reviewed by a regulatory consultant and not part of a
submission. It exists so the content is ready when that review happens, and so
the claims here can be checked against what the software actually does.
1 · Product
Diaco Studio, version — see the owner panel. Manufacturer, address, contact: to be completed.
Computer-aided design software for prosthetic sockets and orthotic insoles, for use by qualified prosthetists and orthotists.
2 · Intended purpose
Diaco Studio shapes geometry for prosthetic and orthotic devices from measurements taken by, and parameters entered by, a qualified practitioner. Its output is an approved design -- a 3D model, a report and a print project the practitioner may download -- and, when the practitioner orders it, a print order to the manufacturer, who makes the device to that approved design and delivers it.
It is a design tool. It does not diagnose, does not prescribe, does not determine treatment, and does not approve a device for a patient. Every design is reviewed and approved by the practitioner, who remains responsible for the clinical decision and for the fit of the finished device.
3 · Intended users
Qualified prosthetists and orthotists, and technicians working under their supervision. Users are expected to be competent in socket and insole design and in additive manufacture. The software assumes, and does not replace, that competence.
4 · Intended patient population
Patients under the care of the practitioner using the software. The software makes no independent assessment of suitability.
5 · Regulatory position — to be confirmed
The practitioner takes every clinical decision. The software performs geometric construction from operator-entered parameters and presents measurements of the geometry it produced.
Classification under MDR Annex VIII (including Rule 11) has not been confirmed by a regulatory assessor. The finished physical device is a custom-made device, made to the practitioner's approved design and prescription; whether the practitioner or the manufacturer of this software is the manufacturer of that device under MDR Article 2(30) is an open question recorded in mdr-position.md (section 4.3). Do not treat this section as a determination.
6 · Contraindications and limits
- Not for use where the practitioner has not examined the patient.
- Not for use with a scan the practitioner has not verified against the patient.
- Structural analysis is an analytical estimate, not finite element analysis. It models the material as isotropic. It is not a substitute for physical testing to ISO 10328.
- Wall thicknesses are entered by the practitioner. The software offers no value and validates only the numeric range.
- Print settings are not generated by the software. Devices are printed at the manufacturer's farm on profiles measured on the machine that runs the part; the software refuses to build a print project without one.
7 · Warnings
Verify the scan before designing. Every downstream step trusts the scan completely. Compare at least two section circumferences against direct measurement of the patient.
Check the side. A left insole printed for a right foot is a harmful device. The software mirrors exactly, and the side is shown throughout — confirm it on the part.
A socket is printed only on a validated profile. Without one the manufacturer's tooling refuses to build the print project and says so. The files a practitioner downloads carry geometry and no print settings.
A structural estimate is not a test. A socket carries the patient's body weight.
Approval is a clinical act. Confirming a design records the practitioner as having approved it.
8 · Residual risks
| Risk | Mitigation in the software |
|---|---|
| Design built from a wrong or corrupted scan | Cleanup warnings; measurements shown for comparison; component-count warning |
| Socket too thin under load | Practitioner enters the thickness; wall is measured by ray casting and reported with its sample count; open meshes report "not measured" rather than a number |
| Wrong side manufactured | Exact mirroring, verified; side shown in the interface, the filename and the engraving |
| Printed on unsuitable settings | Profile validated on install; warning when absent; material warning for a socket profile that is not fibre-filled |
| Patient data disclosed | Records scoped to the owning clinic; audit log; owner-only backup |
| Gait scan retained without consent | The archive is analysed in memory and not persisted; provenance records what was ignored |
| An estimate mistaken for a test | Labelled as an analytical estimate on screen and in the report |
9 · Installation and operating environment
Windows, a browser supporting WebGL2, a machine capable of 3D work. Designing runs locally and needs no internet connection, including for charging the wallet. Ordering a print sends the approved design and the patient's name to the manufacturer and needs a connection.
Backups are the user's responsibility. See quick-start.md.
10 · Reporting
Report any malfunction or any concern about a device designed with this software to the manufacturer at the address in section 1, and to your competent authority where required.
11 · Documents
mdr-position.md— the regulatory position and the arguments behind itai-assistant-plan.md— the planned assistant and its boundariesquick-start.md— installation and first useclinical-workflow.md— the workflow in fulltroubleshooting.md— symptoms and remedies../ERRORS.md— error codes
Still to do before this is an IFU
- Manufacturer identity, address, UDI, symbols, and the CE block
- Regulatory classification confirmed by an assessor
- Clinical evaluation and the risk file behind section 8
- Language versions for each market
- Version and revision control tied to release notes