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The Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.

The Pre-Sutured Tendon is for single patient use only.

The Pre-Sutured Tendon is a donated human nonbone tendon pre-sutured with sterile Ultra-high-molecular-weight polyethylene (UHMWPE) nonabsorbable sutures. The tendon is processed via the BioCleanse® Tissue Sterilization Process (The BioCleanse Process). The Pre-Sutured Tendon device is offered as a single strand and as a quadruple (quad) strand.

This is a 510(k) summary for a medical device called the "Pre-Sutured Tendon." It does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device submission.

As such, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document describes a traditional medical device (a pre-sutured tendon for ligament reconstruction) and its regulatory clearance based on substantial equivalence to existing predicate devices, rather than an AI/ML-driven diagnostic or prognostic device requiring specific performance metrics related to diagnostic accuracy or reader studies. The "Performance Data" section briefly mentions bench testing and a human cadaver study to demonstrate feasibility and user needs, but these are not presented in the format of acceptance criteria for an AI/ML device study.

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