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The Multi-Drive Interference Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand /wrist. Specifically:

Shoulder:
Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Sepair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle:
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction

Knee:
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

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

Hand/Wrist:
Scapholunate Ligament Reconstruction, Unar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs. Ligament Reconstruction and Tendon Interposition

The Multi-Drive Interference Screw System is a family of interference screws for the reattachment and fixation of tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand /wrist. The interference screws are manufactured from HA Enhanced PEEK or titanium alloy in multiple lengths and diameters with key features including a threaded shank, cannulation hole, and multiple drive mating interface. The HA PEEK versions also incorporate tantalum pins for imaging visibility.

The provided text is a 510(k) summary for the Multi-Drive Interference Screw System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document, as a clinical study with detailed performance metrics was not performed or described.

Here's an analysis based on the information available in the text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on non-clinical testing to demonstrate substantial equivalence to predicate devices. The "performance" is implicitly that the device performs comparably to or within the established safety and effectiveness profile of the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as the document describes non-clinical engineering and laboratory tests, not a clinical study on a human test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided as the document does not describe a study involving expert assessment or ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided as the document does not describe a study involving expert assessment or ground truth establishment for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not done. This device is a physical medical implant (interference screw), not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided as the device is not an algorithm but a physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For mechanical testing, the "ground truth" is derived from established engineering standards (ASTM F543) and testing methodologies to determine physical properties and performance characteristics (e.g., torque values, pullout strength). For biocompatibility, the "ground truth" is adherence to endotoxin limits defined by standards (ANSI/AAMI ST72:2011/R2016).

8. The sample size for the training set

This information is not applicable/not provided. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable/not provided. There is no training set mentioned, as this is not an AI/machine learning device.

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