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The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator cuff repair, Bankart repair, SLAP lesion repair, biceps tenodesis, acromio-clavicular separation repair, deltoid repair, capsular shift or capsulolabral reconstruction Foot/Ankle: Lateral stabilization, medial stabilization, achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, and digital tendon transfers Knee: Medial collateral ligament repair, lateral collateral ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, joint capsule closure, and Medial Patellofemoral Ligament Repair/Reconstruction Hand/Wrist: Scapholunate ligament reconstruction, carpal ligament reconstructions, repair/reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty Elbow: Biceps tendon reattachment, ulnar/radial collateral ligament reconstruction, and lateral epicondylitis repair

The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. The anchor is constructed from a hollow braid of polyester with a single loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is pre-loaded on a disposable inserter and will be sold sterile for single-use

This document is a 510(k) Premarket Notification for the Arthrex FiberTak Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K203268) to expand its indications for use to include Medial Patellofemoral Ligament Repair/Reconstruction.

Therefore, the "study" described is mechanical testing rather than a typical clinical study involving human readers or AI algorithms as would be the case for medical imaging devices.

Here's the information based on the provided document:

Acceptance Criteria and Device Performance for Arthrex FiberTak Suture Anchor

Type of Device: Suture Anchor (Class II Medical Device)
Purpose of Submission: Expansion of Indications for Use to include Medial Patellofemoral Ligament Repair/Reconstruction.

This submission relies on mechanical performance testing to demonstrate substantial equivalence for the expanded indication, rather than a clinical study involving human readers or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in this summary. The "test set" here refers to the samples used in the mechanical testing. The standard practice for such testing involves a sufficient number of devices/constructs to achieve statistical significance.
• Data Provenance: The study is reported as "Mechanical testing", implying it was conducted as laboratory-based testing. Country of origin and retrospective/prospective nature are not applicable in the typical sense for this type of testing (it's not patient data).

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable (N/A): This submission pertains to a physical medical device (suture anchor) and its mechanical properties, not a diagnostic or AI-driven imaging device that would require expert-established ground truth from clinical data. The "acceptance criteria" here are based on established engineering and biomechanical literature for sufficient tensile strength in the context of ligament repair.

4. Adjudication Method for the Test Set

• N/A: As this is mechanical testing, there is no adjudication process involving multiple human reviewers. The results are quantitative measurements of physical properties.

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

• No: An MRMC comparative effectiveness study was not performed as this is not an imaging or diagnostic device. The study is focused on the mechanical performance of the suture anchor.

6. Standalone Performance (Algorithm Only)

• N/A: This is not an algorithm or AI device.

7. Type of Ground Truth Used

• Literature-established Mechanical/Biomechanical Criteria: The "ground truth" for success in this context is the fulfillment of established criteria for pull-out (tensile) strength, derived from published literature relevant to Medial Patellofemoral Ligament Repair/Reconstruction.

8. Sample Size for Training Set

• N/A: No "training set" is applicable as this is not a machine learning model.

9. How Ground Truth for Training Set was Established

• N/A: No "training set" is applicable.

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The Arthrex FastThread Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; specifically,

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair, MPFL Repair/Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist

The Arthrex FastThread Interference Screw is a cannulated, fully threaded, bioabsorbable interference screw, manufactured from PLDLA, Biphasic Calcium Phosphate and hydroxyapatite (HA). The screws measure 6-12 mm in diameter and 20-30 mm in length.

The provided document is a 510(k) Summary for a medical device, the Arthrex FastThread Interference Screw. It outlines the device's indications for use, its comparison to predicate devices, and the performance data submitted for its clearance.

However, the information provided does not contain details about acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods for an AI/ML-based medical device study.

Instead, this document describes the regulatory submission for a physical, implantable medical device (an interference screw) and its mechanical and biological performance data. The "Performance Data" section specifically states:

• "Mechanical testing demonstrated that the pull-out strength of the proposed Arthrex FastThread Interference Screw met the acceptance criterion established by K201749 for MPFL repair/reconstruction."
• "Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications."

This indicates that the acceptance criteria and study proving the device meets them are related to the physical properties and safety of the implantable screw, not to the performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding AI/ML device performance from this document. The questions posed in your prompt (e.g., "Number of experts used to establish the ground truth", "Adjudication method", "MRMC comparative effectiveness study", "Standalone performance", "Training set ground truth") are relevant to the evaluation of AI/ML software as a medical device, which is not what this document describes.

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