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VERSALOK Anchor is indicated for use in the following: Shoulder: Rotator Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment

The Versalok Anchor System includes the Versalok Anchor, which will be presented sterile, pre-mounted on an inserter shaft w/anvil with a threader tab and suture. The System will be deployed with the use of a reusable Deployment Gun. The system could be provided with a variety of #2 suture options.

This 510(k) summary for the Versalok Anchor does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document is a standard 510(k) submission summary, primarily focused on establishing substantial equivalence to predicate devices. It discusses:

• Submitter and Contact Information: DePuy Mitek, Ruth C. Forstadt.
• Device Name: Versalok Anchor.
• Classification: Orthopedic fasteners (Smooth or threaded metallic bone fixation fastener).
• Substantial Equivalence: States it is substantially equivalent to the Trident Anchor (K060914).
• Device Description: Describes the anchor, inserter, threader tab, suture, and deployment gun.
• Indications for Use: Lists specific applications in the shoulder, knee, and elbow.
• Safety and Performance: Simply states that "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies because this information is not present in the provided text.

The document focuses on regulatory classification and substantial equivalence, not on a detailed performance study with quantifiable acceptance criteria. For medical devices, "performance testing" in the context of a 510(k) often refers to bench testing (e.g., mechanical strength, pull-out strength) to demonstrate that the new device performs similarly to or better than the predicate device under simulated conditions, rather than a clinical study with human patients. However, the exact details of such testing, including acceptance criteria and results, are not included in this summary.

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