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The Arthrex NanoSuture 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 NanoSuture Anchor is a fully threaded suture anchor pre-loaded with Arthrex suture on a disposable inserter. The anchor is manufactured from titanium and measures 1.7 mm in diameter and 5 mm in length.

The provided document describes the Arthrex NanoSuture Anchor, which is a fully threaded suture anchor. The submission is a Special 510(k) premarket notification to obtain clearance for a line extension to the Arthrex MicroSuture Anchors family (K112237). The device is intended for suture or tissue fixation in various anatomical locations.

Here's the information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Pullout testing was conducted to demonstrate that the proposed Arthrex NanoSuture Anchor perform statistically equivalent to the predicate." It also mentions "Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications." However, specific numerical acceptance criteria or performance metrics for "statistically equivalent" or "pyrogen limit specifications" are not provided in the document.

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample size used for the pullout testing or bacterial endotoxin testing. It also does not mention the data provenance (e.g., country of origin or whether it was retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable as the studies outlined are engineering/laboratory tests (pullout strength and endotoxin levels), not studies requiring expert interpretation of medical images or patient data to establish ground truth.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done, as this is a medical device (suture anchor) and not an AI or imaging diagnostic device that would involve human readers.

6. Standalone (Algorithm Only) Performance:

This section is not applicable as the device is a physical medical implant, not a software algorithm.

7. Type of Ground Truth Used:

The ground truth for the performance evaluations (pullout testing and bacterial endotoxin testing) would be:

• Pullout Testing: Direct measurement of mechanical strength parameters (e.g., maximum load, displacement at failure) compared against a defined standard or the performance of the predicate device.
• Bacterial Endotoxin Testing: Laboratory measurement of endotoxin levels against a specified pyrogen limit.

8. Sample Size for the Training Set:

This is not applicable. The device is a physical product, not a machine learning model that requires a training set. The "training" here refers to the development and manufacturing processes of the device itself.

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

This is not applicable, as there is no "training set" in the context of an algorithm. For the device manufacturing and design, the "ground truth" and standards would be established through engineering specifications, material science, biomechanical principles, and regulatory requirements.

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