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The AlphaVent Knotless SP PEEK Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or Adjunct Fixation for ACL/PCL Reconstruction or Repair, Meniscal Root Repair, MPFL Repair/Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair, Proximal Hamstring Repair

The AlphaVent Knotless SP PEEK Anchors (herein referred to as the subject device(s)) are bone anchors with a screw-in mechanism. The subject device system is comprised of a poly-ether-etherketone (PEEK) eyelet and anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone via self-punching or after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS). The AlphaVent Knotless SP PEEK Anchors are sterilized via Ethylene Oxide to a Sterility Assurance Level of 106. The devices are intended to be used in a professional healthcare facility.

This document is a 510(k) summary for the AlphaVent Knotless SP PEEK Anchor, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the way typically seen for a diagnostic or AI-driven device.

Therefore, many of the requested categories for describing acceptance criteria and a study proving device performance are not applicable or cannot be extracted from this type of regulatory submission. This document highlights benchtop testing for product safety and equivalence, not clinical performance against ground truth.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present:

Acceptance Criteria and Device Performance Study (Based on 510(k) Summary)

This 510(k) summary focuses on demonstrating substantial equivalence of the AlphaVent Knotless SP PEEK Anchor to a legally marketed predicate device (Arthrex SwiveLock Anchor, K203495) and a reference device (Stryker AlphaVent PEEK Suture Anchor, K231093). The "study" described is a series of non-clinical benchtop tests, a biological risk assessment, and bacterial endotoxin testing, designed to show the new device performs at least as safely and effectively as the predicate.

1. A table of acceptance criteria and the reported device performance

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable. (See point 8).

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