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The Small Size DePuy Mitek Milagro® Interference Screws are indicated as follows: Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. Knee: Medial and lateral collateral ligament repair Shoulder: Proximal bicep tenodesis Elbow: Distal bicep tenodesis

The Small Size DePuy Mitek Milagro® Interference Screw is an absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP). The proposed Small Size DePuy Mitek Milagro® Interference Screws are offered in diameters of 5mm and 6mm and lengths of 23mm and 30mm.

The provided text is a 510(k) summary for the DePuy Mitek Milagro® Interference Screws and does not contain information about studies related to software performance, AI, or diagnostic algorithm acceptance criteria. Instead, it describes a medical device, its intended use, and its substantial equivalence to previously cleared predicate devices based on non-clinical (mechanical) testing.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to a diagnostic algorithm.
2. Sample sizes for test sets, data provenance, or expert ground truth establishment.
3. Adjudication methods.
4. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
5. Standalone algorithm performance.
6. Ground truth types for diagnostic algorithms.
7. Training set sample sizes or ground truth establishment for training sets.

The document explicitly states:

"Product Design Verification activities, such as, Insertion Torque, Anchor Pullout (at T=0, 6 and 12 week in-vitro physiological aging), and Torque to Failure were performed on the implant." (Page 2)

"Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate devices." (Page 2)

This indicates that the "study" proving the device meets acceptance criteria was a series of non-clinical mechanical tests to demonstrate substantial equivalence to previously cleared devices, not a study evaluating a diagnostic algorithm or AI performance.

The acceptance criteria for this device are implied to be the successful demonstration of comparable mechanical properties (Insertion Torque, Anchor Pullout, Torque to Failure) to the predicate devices, thereby ensuring comparable safety and effectiveness. The reported "device performance" is that these tests showed substantial equivalence to the predicate devices.

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