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The Harpoon® Suture Anchors are indicated for use in soft tissue reattachment in the following indications:

• 1. Shoulder (Harpoon and Mini-Harpoon Suture Anchors)
  • Bankart Repair
  • SLAP Lesion Repair
  • Acromio-Clavicular Separation Repair
  • Rotator Cuff Repair
  • Capsule Repair and Capsulolabral Reconstruction
  • Biceps Tenodesis
  • Deltoid Repair
• 2. Wrist (Mini-Harpoon Suture Anchor only)
  • Scapholunate Ligament Reconstruction
• 3. Elbow (Harpoon and Mini-Harpoon Suture Anchors)
  • Biceps Tendon Reattachment
  • Ulnar or Radial Collaterial Ligament Reconstruction
• 4. Knee (Harpoon and Mini-Harpoon Suture Anchors) Extra-Capsular Repair:
  • Medial Collateral Ligament Repair
  • Lateral Collateral Ligament Repair
  • Posterior Oblique Ligament Repair
  • Joint Capsule Closure
  • Iliotibial Band Tenodesis Reconstruction
  • Patellar Realignment and Repair
  • Patellar Ligament and Tendon Repair
  • Vastus Medialis Obliquus (VMO) Muscle Advancement

The suture anchor with suture attached is pushed into the bone for anchorage of the soft tissue to the bone. The anchor is designed with a angled point and can be tapped directly into bone without a pre-drilled bone hole. The collar of the device is divided into four proximally open fins which provide resistance to pull-out forces applied to the device. The Harpoon® Suture Anchors are manufactured from 316 IVM stainless steel conforming to ASTM F-138. The suture anchor is provided pre-threaded with a polyester suture.

The provided text describes the Harpoon® Suture Anchors and their indications for use, as well as the FDA's clearance (K973775) acknowledging their substantial equivalence to predicate devices. However, the document does not contain information regarding a specific study with acceptance criteria and reported device performance in the format requested.

The text states:
"Mechanical testing of these devices demonstrated its pull-out strength to be comparable to commercially available suture anchors with the same indicated use."

This implies that some form of "mechanical testing" was performed to compare the Harpoon® Suture Anchors to existing devices, and that the results met an implicit acceptance criterion of "comparability" for pull-out strength. However, the details of this testing, including the specific quantitative acceptance criteria, the methodology, sample size, or the explicitly reported performance values, are not provided.

Therefore, an answer in the requested format cannot be fully generated from the provided text.

Here's an explanation of what is and isn't available:

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

   • Acceptance Criteria: Not explicitly stated in quantitative terms. The text mentions "comparable to commercially available suture anchors with the same indicated use" for pull-out strength.
   • Reported Device Performance: Not numerically reported. The text only states that it was "comparable."

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was mechanical testing, not a human reader study requiring expert ground truth in the context of diagnostic performance.

4. Adjudication method for the test set: Not applicable for mechanical testing.

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 document is for a medical device (suture anchor), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" would be the direct measurement of pull-out strength under controlled experimental conditions, often against established engineering standards or direct comparison to predicate devices, but the specifics are not detailed.

8. The sample size for the training set: Not applicable, as this refers to training a model, not performing mechanical device testing.

9. How the ground truth for the training set was established: Not applicable.

Conclusion based on the provided text:

The document states that "Mechanical testing of these devices demonstrated its pull-out strength to be comparable to commercially available suture anchors with the same indicated use." This serves as the implicit acceptance criteria and the study finding for the device. However, the specific quantitative details of this testing are not provided in the submitted text.

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