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The Stryker ICONIX with Needles Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, wrist, elbow, and shoulder. See indications below.

Elbow: Biceps Tendon Reattachment. Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodess, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor And Extensor Tendons at the PIP, DIP, and MCP Joint for All Digits, Digital Tendon Repair

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

ICONIX with Needles (herein referred to as the proposed device(s)) are all suture anchors with a push-in design, provided sterile and preloaded on a disposable inserter. The anchors consist of a polyester sheath interwoven over non-absorbable working sutures. Needles are housed in a compartment within the inserter handle and are swaged to the free ends of all working sutures. Fixation is achieved by the polyester sheath bunching when the anchor is deployed. The inserter handle will contain needles for use at the surgeon's discretion. The anchor and inserter will be packaged in a single-use sterile barrier system (SBS) containing a disposable drill guide to aid in anchor implantation.

This is a 510(k) premarket notification for a medical device called "Stryker ICONIX with Needles," which is a metallic bone fixation fastener. The document describes the device, its intended use, and comparison to predicate devices, but it does not contain the kind of detailed information about acceptance criteria and a study to prove device performance that your request asks for, particularly concerning AI/software performance metrics (e.g., sensitivity, specificity, AUC).

The document states:

• "Non-clinical benchtop testing was performed to verify the fixation strength following cyclical loading of the ICONIX with Needles products."
• "This fixation strength was compared to that of Predicate A through statistical analysis."
• "The comparison indicates that the proposed devices provide equivalent fixation strength to the devices of Predicate A, and will be functional within the intended use."
• "Clinical testing was not required to demonstrate substantial equivalence for this submission."

This indicates that acceptance criteria would likely be related to fixation strength and that the study involved benchtop testing comparing the proposed device to a predicate device in terms of this physical property. However, the specific numerical acceptance criteria (e.g., minimum fixation strength, statistical margin for equivalence) and the exact reported performance results are not provided in the document.

Therefore, I cannot fulfill your request for items 1-9 based on the provided text, as the document does not contain the specific performance metrics (like sensitivity, specificity, effect size of human readers improving with AI, etc.) that would typically be found for a device involving AI or imaging analysis. The product described is a physical medical implant (a bone fixation fastener), not a software or AI-driven diagnostic/decision support system.

Summary of missing information based on your request:

1. A table of acceptance criteria and the reported device performance: Not provided in detail. It generally states "equivalent fixation strength."
2. Sample sized used for the test set and the data provenance: Not provided. The study was benchtop testing, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as it's not an AI/diagnostic study.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the requested sense; physical properties of the device were tested.
8. Sample size for the training set: Not applicable (no training set for an AI).
9. How the ground truth for the training set was established: Not applicable.

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