(204 days)
The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints
The EXTREMITY MEDICAL Midfoot Screw System
The provided 510(k) summary for the EXTREMITY MEDICAL Midfoot Screw System (K082934) does not contain information about acceptance criteria or a study demonstrating device performance against such criteria for AI/ML device functionalities.
The document describes a medical implant system, which are physical devices used for fixation and arthrodesis of foot joints, not an AI/ML-driven device. Therefore, the requested information points, which are primarily relevant to AI/ML device validation, are not applicable or available within this 510(k) submission.
Specifically:
- 1. A table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence to predicate devices based on design, materials, indications for use, and mechanical properties.
- 2. Sample sized used for the test set and the data provenance: Not applicable. No test set for AI/ML performance is mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for AI/ML is mentioned.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The document indicates that the device's substantial equivalence was based on:
- Indications for use: Same as predicate devices.
- Materials: Similar to predicate devices.
- Design: Similar to predicate devices.
- Test data: Implies mechanical testing data, but specific acceptance criteria and detailed results are not provided in this summary.
- Principles of operation: Similar to predicate devices.
This 510(k) establishes substantial equivalence for a conventional medical device, not an AI/ML product.
§ 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.