(49 days)
Kirschner wires (K-Wires) and Steinmann pins are used for fixation of bone reconstruction, as guide pins for insertion of other implants, or to be implanted through the skin so that traction may be applied to the skeletal system. The pins and wires may be used in the threaded form depending upon the desired application.
Zimmer Kirschner Wires and Steinmann Pins are used for fracture stabilization during the healing process. These wires are available in multiple diameters and lengths and threaded/unthreaded (smooth) versions.
The provided document describes the Zimmer Kirschner Wires and Steinmann Pins and their substantial equivalence to predicate devices, not an AI/ML powered medical device. Therefore, much of the requested information regarding AI/ML study specifics (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this submission.
However, I can extract the relevant information regarding acceptance criteria and performance as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on standards/tests) | Reported Device Performance |
|---|---|
| Biocompatibility: Conformance to ISO 10993-1 and Good Laboratory Practices (21 CFR § 58) | All testing passed. (Device materials are biocompatible) |
| Material / Dimensional Properties: Conformance to ASTM F366-10 and ISO 5838-1 standards | All items in scope were in conformance with these standards. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document refers to "the Pins and Wires materials" and "All items in the scope" for testing.
- Data Provenance: Not explicitly stated, however, the testing was conducted per international and national standards (ISO 10993-1, ASTM F366-10, ISO 5838-1) and US Good Laboratory Practices (21 CFR § 58). This implies the testing was performed in a controlled laboratory environment. Retrospective or prospective nature is not applicable as this concerns physical device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission pertains to physical medical devices (wires and pins), not an AI/ML algorithm requiring expert ground truth for interpretation. The ground truth is objective measurement against specified standards.
4. Adjudication method for the test set
- Not applicable. See point 3. Testing involves objective measurements and adherence to engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used
- The ground truth for the performance testing was established by objective technical standards and material specifications. Specifically:
- Biocompatibility: Conformance to ISO 10993-1 and 21 CFR § 58.
- Material and Dimensional Properties: Conformance to ASTM F366-10 and ISO 5838-1.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.