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The intended use of the Stryker Wedge Suture Anchor System is for securing soft tissue to bone in such procedures as rotator cuff repair, Bankart lesion repair, and SLAP lesion repair in the Shoulder, as well as Achilles tendon repair in the foot/ankle, medial collateral ligament repair in the elbow, biceps tendon reattachment in the elbow, and bladder neck suspension in the pelvis. The suture anchor engages in bone so as to provide a stable, bony attachment site for the soft tissue. The device is intended to be used primarily in arthroscopic procedures, but may be used in open procedures as well, and is intended for single-use only.

The line extension of the Stryker Wedge Suture Anchor System consists of a titanium alloy (Ti 6A1 4V ELI) screw-in type anchor pre-threaded with nonabsorbable braided polyethylene surgical suture, and pre-assembled on a disposable inserter.

The provided text describes a 510(k) premarket notification for a medical device called the "Stryker Wedge Suture Anchor System line extension." This submission focuses on establishing substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results in the manner requested. Specifically, it does not contain information about:

• Acceptance criteria expressed as specific performance metrics (e.g., success rates, accuracy thresholds).
• Detailed device performance figures against such criteria.
• Sample sizes for test sets or training sets in the context of performance studies.
• Data provenance for such studies.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance studies (beyond substantial equivalence comparison).
• The type of ground truth used for performance evaluation.
• How ground truth for a training set was established.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the "line extension of the Stryker Wedge Suture Anchor System is substantially equivalent in material of construction, overall design, intended use, and safety and efficacy to the predicate device."
• Predicate Device: The predicate device is identified as the "Stryker Wedge Suture Anchor System (#K983557)."
• Performance Claim: "The subject device was shown to have substantially equivalent performance when compared to the predicate device."
• Other details: Sterilization methods, biocompatibility, and materials are mentioned as part of ensuring safety and equivalence.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, study types, ground truth specifics, etc.) from the provided text, as this type of information is typically not included in a 510(k) summary focused on substantial equivalence. The document doesn't detail specific performance studies with quantitative acceptance criteria, but rather asserts equivalence to a previously cleared device.

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