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Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are:

Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair

Wrist - Scapholunate ligament reconstruction

Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair

Knee - Extracapsular Repair (Medial collateral ligament repair, lateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement

Foot and Ankle - Hallux valgus repairs, medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, and metatarsal ligament/tendon repair/reconstruction

Hip - Capsular Repair (acetabular labral repair)

The Harpoon® Suture Anchor is comprised of either stainless steel or titanium material designed with a collar that provides resistance to pullout of the device. It is preloaded with a polyethylene suture and available in two sizes.

The provided text is a 510(k) Summary for the Harpoon® Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically seen for diagnostic or AI-driven medical devices.

Therefore, most of the requested information cannot be extracted from this document.

Here's an assessment based on the available text:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or a reported device performance table as would be expected for a diagnostic or AI device. Instead, it states:

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

2. Sample size used for the test set and the data provenance

A test set was not used in the context of performance evaluation against acceptance criteria, as no clinical testing or specific non-clinical performance evaluation against predefined criteria is detailed.

• Sample Size (Test Set): Not applicable, as no dedicated "test set" for performance evaluation is described.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no ground truth was established from expert review for a test set in this 510(k) submission.

4. Adjudication method for the test set

Not applicable, as no test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

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

This concept is not relevant to the Harpoon® Suture Anchor, which is a physical medical device (suture anchor), not an algorithm or a software device.

7. The type of ground truth used

Not applicable. The "ground truth" concept (e.g., pathology, expert consensus) is typically associated with the evaluation of diagnostic or prognostic devices/algorithms. For a physical device like a suture anchor, "ground truth" would refer to its physical properties and mechanical performance, which were assessed via non-clinical testing. However, the details of how this was established are not provided other than: "Non-clinical laboratory testing was performed to determine substantial equivalence."

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary of what the document does provide regarding "proof" of meeting criteria:

The document leverages the concept of substantial equivalence to predicate devices. The "study" that proves the device meets (implicitly, rather than explicitly stated) acceptance criteria is the non-clinical laboratory testing that compared the Harpoon® Suture Anchor to its predicates.

"Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."

This implies that the non-clinical tests (e.g., mechanical strength, pull-out force, material biocompatibility, etc. – although not detailed in this summary) demonstrated performance comparable to the predicate devices, thereby supporting the claim that it is "functional within its intended use" and "substantially equivalent." No specific quantitative acceptance criteria or detailed results from these non-clinical tests are included in this 510(k) Summary.

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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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