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The LigaMetrics Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.

Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.

Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.

Hip: Distal row abductor tendon repair

The LigaMetrics Suture Anchors are offered in Threaded and Push-In versions and are designed to secure soft tissue to bone. The implant is marketed with previously cleared ultra-high molecular weight polyethylene (UHMWPE) 2.0mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc.

The provided text describes the LigaMetrics Suture Anchors, a medical device for reattaching soft tissue to bone. It is a 510(k) premarket notification and therefore focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance for a study proving the device meets acceptance criteria cannot be fully extracted from this document, as such a study is explicitly stated as not needed.

Specifically, the document states: "Clinical data were not needed to support the safety and effectiveness of the subject device." This indicates that the FDA's substantial equivalence determination for this device was based on non-clinical testing and comparison to predicate devices, not on a clinical study with acceptance criteria in the manner typically seen for new diagnostic algorithms or treatments requiring clinical efficacy trials.

However, I can extract information related to the nonclinical testing performed to demonstrate substantial equivalence, which serves a similar purpose in the 510(k) pathway.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "device performance" measurements as would be expected for a clinical efficacy study. Instead, it details that "Side-by-side mechanical performance testing demonstrates that the design differences between the LigaMetrics Suture Anchor subject devices and the Footprint Ultra PK Suture Anchor predicate device introduce no new issues of safety or effectiveness."

This implies that the acceptance criteria were that the LigaMetrics Suture Anchors' mechanical performance should be substantially similar to or better than the predicate devices, and the reported device performance met this implicit criterion through the nonclinical tests.

The specific nonclinical tests performed were:

• Insertion Testing
• Pullout Strength Testing
• Static Interconnection Strength Testing
• Fatigue Testing

The document concludes that "All necessary testing has been performed for the worst-case LigaMetrics Suture Anchors to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended."

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated as "sample" but "test units representative of finished devices" were used for nonclinical testing. The exact number is not provided.
• Data Provenance: The data is from non-clinical mechanical testing, not human or patient data. Therefore, concepts like country of origin or retrospective/prospective do not apply in the typical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The ground truth for mechanical testing is based on engineered specifications and comparison to predicate device performance, not expert human interpretation.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are relevant for human interpretation and consensus, which was not part of this nonclinical testing.

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 data were not needed to support the safety and effectiveness of the subject device."

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

Not applicable. This device is a physical medical implant (suture anchor), not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the nonclinical testing, the "ground truth" would be established by validated mechanical testing methodologies and the known mechanical properties and performance of the predicate devices. The goal was to show comparable mechanical performance.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established:

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

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