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The Arthrex Tenodesis PushLock Anchor is intended to provide soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically;

Shoulder: Rotator Cuff Repairs, 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

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 PushLock Tenodesis Anchor is a push-in anchor made of Polyetherether-ketone. This is the same material of the predicate device. The proposed anchor is designed with either a forked or closed eyelet and comes preloaded on a disposable inserter. These are similar features to the cleared Arthrex PushLock (K101679) and Arthrex SwiveLock (K101823) suture anchors. The proposed anchor is offered sterile.

The provided text describes a medical device, the Arthrex PushLock Tenodesis Anchor, and its substantial equivalence to a predicate device. However, it does not contain information regarding a study with acceptance criteria and device performance as typically understood for AI/software devices, nor does it provide details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The "Performance Data" section solely refers to tensile testing and bacterial endotoxin testing, which are standard engineering and biocompatibility tests for physical medical implants, not performance metrics for an AI or digital health device.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided document.

Here's a breakdown of why I cannot generate the requested table and study description based on the input:

• No AI/Software Device: The document describes a physical medical implant (a tenodesis anchor), not an AI/software device. Acceptance criteria and performance metrics for a physical implant are typically mechanical strength, biocompatibility, and sterility, not diagnostic accuracy, sensitivity, or specificity.
• No Clinical Study for Performance (as requested): The "Performance Data" section details physical and chemical tests (tensile testing and bacterial endotoxin testing), not a clinical study involving human subjects or data analysis for diagnostic or prognostic performance.
• Missing Information: All specific points requested (sample size for test set, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set size, training set ground truth) are absent because they are relevant to AI/software validation, which is not what this document addresses.

In summary, the provided document is a 510(k) summary for a physical medical implant, not a study report for an AI-powered device. Therefore, the information requested in the prompt is not available in the given text.

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