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The Arthrex ACL RetroConstruction™ Button Kit for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons and recommending use of size 2 or size 5 FiberWire™ or equivalent. Specifically, Arthrex will be offering this for ACL repair.

Arthrex, Inc. ACL RetroConstruction™ Button Kit consists of metal buttons. These buttons are Titanium 6AL4V ELI and have either 2 or 4 holes for inclusion of suture. The suture recommended for use with this kit is FiberWire™, an Arthrex product, which is offered in various sizes and configurations.

The provided text is a 510(k) summary for the Arthrex ACL RetroConstruction™ Button Kit. This type of regulatory submission focuses on demonstrating substantial equivalence to pre-existing devices rather than independent performance studies with detailed acceptance criteria for a new medical device technology like an AI-powered diagnostic tool.

Therefore, the document does not contain the information requested in the prompt. It primarily discusses:

• Intended Use of the device.
• Description of the components.
• Substantial Equivalence to legally marketed predicate devices, meaning it has the same basic features and intended uses, and any minor differences do not raise questions of safety or effectiveness.

There are no details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used (pathology, expert consensus, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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