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The Lync® intramedullary implants are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bone fusion.

Lync® intramedullary implants are single-use bone fixation devices intended to be permanently implanted. Lync® intramedullary implants are made of unalloyed titanium.

The provided text is a 510(k) Summary for the Lync® intramedullary implant by Novastep, which is a medical device. This document does not pertain to an AI/ML device, but rather a physical implant. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC, standalone performance, ground truth, training set details) is not applicable or cannot be extracted from this type of regulatory submission.

The document discusses the substantial equivalence of the Lync® intramedullary implant to predicate devices based on mechanical characteristics, material, intended use, and indications for use. It references compliance with ASTM F564-10 for metallic bone staples and ISO 5832-2 for unalloyed titanium. Biocompatibility was evaluated according to ISO 10993-1.

Key points from the document regarding device testing:

• Mechanical characteristics: Tested according to ASTM F564-10 Sections A1, A2, and A4 (Standard Specification and Test Methods for Metallic Bone Staples). These tests would likely involve static bending, dynamic bending, and pull-out resistance.
• Material: Conforms to ISO 5832-2 (Implants For Surgery - Metallic Materials – Part 2: Unalloyed Titanium).
• Biocompatibility: Evaluated in accordance with ISO 10993-1.

Since this is a 510(k) submission for a non-AI medical device, a direct mapping to the requested AI/ML specific criteria (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone algorithm performance, training set details) is not possible. The document explicitly states: "Clinical studies were not required for this submission" and "Animal studies were not required for this submission." The basis for clearance is demonstrating substantial equivalence to legally marketed predicate devices through comparison of technological characteristics, materials, and mechanical performance.

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