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The CoLS® PEEK is designed for the fixation of tendons graft to the femur and tibia during orthopedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.

The CoLS® PEEK is a screw made out of PEEK (Poly-Ether-Ketone) and used with the tape of TLS® fixation system agreed by FDA K080974. To standardize CoLS® range, the TLS® tape will be called CoLS® tape. The difference between CoLS® screw made out of PEEK and TLS® screw made out of titanium is only the raw material. The CoLS® PEEK is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

Here's a breakdown of the acceptance criteria and study information for the CoLS® PEEK device, based only on the provided text:

Important Note: The provided document is a 510(k) Premarket Notification summary for a medical device. This type of submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving enhanced effectiveness or an "effect size" as typically seen in AI/ML performance studies. Therefore, many of the requested categories related to AI/ML performance (e.g., human reader improvement with AI, multi-reader multi-case studies, training set details) are not applicable to this traditional medical device submission.

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified for the performance testing.
   • Data Provenance: Not explicitly stated, but the manufacturer is based in France (Fournitures Hospitalières industrie, Quimper, France). The testing was for a physical device, not patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is a physical device performance test (insertion torque), not an assessment of diagnostic performance requiring expert interpretation.

3. Adjudication method for the test set:

   • Not applicable. This is a physical device performance test adhering to a standard (ASTM F543-07). Adjudication methods like 2+1 or 3+1 are typically for clinical or imaging studies where expert consensus is needed.

4. 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:

   • No, a MRMC comparative effectiveness study was not done. This device is a fixation screw, not an AI-powered diagnostic or assistive tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithm or AI device. The device's "performance" refers to its mechanical properties.

6. The type of ground truth used:

   • The "ground truth" for the device's performance was the standardized method and results defined by ASTM F543-07 for insertion torque testing. The predicate devices' performance in similar tests would have served as a benchmark for substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This is a traditional medical device, not an AI/ML device that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI/ML model.

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