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The Arthrex Graft-Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
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

The Arthrex Graft-Anchor is a one-piece titanium “push-in” anchor and comes pre-loaded on a driver.

This is a 510(k) summary for a medical device called the Arthrex Graft-Anchor, which is a bone fixation screw. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove efficacy or deriving acceptance criteria from such trials. Therefore, the information requested regarding acceptance criteria and studies demonstrating that the device meets those criteria, as typically understood for AI/diagnostic devices, is not directly applicable in the same way.

However, based on the provided text, I can infer and extract information relevant to the substantial equivalence argument, which serves a similar function to demonstrating device performance.

Here's an analysis based on your questions:

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

The acceptance criteria in this context are tied to the concept of substantial equivalence to the predicate device (K063479: Arthrex Mini PushLock). The primary performance characteristic used for comparison is pull-out strength.

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

• Sample Size for Test Set: Not specified in the provided document. The "test set" here refers to the number of Arthrex Graft-Anchors used in the mechanical testing.
• Data Provenance: Not specified, but given it's mechanical testing by the manufacturer (Arthrex, Inc., based in Naples, FL, USA), it's highly likely to be internal, prospective mechanical testing conducted in the USA.

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)

Not applicable. For a mechanical device like a bone fixation screw, the "ground truth" for performance is established through physical mechanical testing according to recognized standards, not by expert consensus or interpretation of clinical data in the same way an AI diagnostic would be. There are no experts in this context establishing "ground truth" for device performance.

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

Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading). Mechanical testing results are objective measurements.

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

Not applicable. This is a medical device (bone fixation screw), not an AI diagnostic algorithm or an assistive technology for human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the performance claim (pull-out strength) is established through physical mechanical testing and measurement. This typically involves laboratory setups designed to apply controlled forces and measure the point at which the anchor fails or dislodges from a surrogate material (e.g., synthetic bone).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a "training set."

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

Not applicable. As above, this device does not involve a training set.

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