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The Arthrex Knee FiberTak® Button 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, medial patellofemoral ligament repair/reconstruction, and quadriceps tendon repair
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 Knee FiberTak® Button 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

The provided text is a 510(k) Summary for the Arthrex Knee FiberTak® Button Suture Anchor, specifically for an expanded indication for quadriceps tendon repair. This document describes a medical device and its regulatory clearance process, not an AI or software-based device that would typically have the acceptance criteria and study detailed in the prompt.

Therefore, the information requested in your prompt (acceptance criteria, study details for a device meeting these criteria, sample sizes, ground truth establishment, expert qualifications, MRMC studies, etc.) is not present in the provided document. This document pertains to the mechanical and functional equivalence of a physical medical implant.

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