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The GRYPHON™ Flex Knotless Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures:
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Superior Capsule Reconstruction (Glenoid Only)
Hip: Acetabular Labral Repair
Knee: MCL, LCL, Iliotibial Band Tenodesis
Foot/Ankle: Lateral Stabilization, Medial Stabilization

The proposed GRYPHON™ Flex Knotless PEEK and BIOCOMPOSITE Anchors is a line extension to the currently marketed GRYPHON Anchor family. The proposed product is a knotless anchor intended for fixation of soft tissue to bone in various soft tissue repair procedures. In its finished good configuration, the proposed device is a two-piece design; comprised of a permanent implant (anchor) component and a disposable (inserter) component. The 2.7mm anchor implant is preloaded on the inserter and a Nitinol distal tip retains the suture and the anchor while the device is malleted into the bone. The design offers surgeons maneuverability within the joint space. The disposable inserter will be offered in two design configurations, straight or curved to accommodate varying anatomies.
The proposed GRYPHON Flex Knotless PEEK and BIOCOMPOSITE Anchors will be available in a 2.7 mm size, molded from either Polyetheretherketone (PEEK) material or Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material.
Both the GRYPHON Flex Knotless PEEK and BIOCOMPOSITE Anchors are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "GRYPHON™ Flex Knotless PEEK Anchor" and "GRYPHON™ Flex Knotless Biocomposite Anchor."

This document does not describe a study that uses AI or machine learning. It describes the non-clinical verification activities performed for a physical medical device (suture anchor), focusing on its mechanical properties, sterilization, and biocompatibility. Therefore, it does not include the information requested regarding acceptance criteria and studies for AI/ML device performance, such as sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment, or training set details.

The acceptance criteria mentioned in the document relate to the physical and biological performance of the anchor, not to the performance of a diagnostic or predictive algorithm.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies that prove an AI/ML device meets those criteria based on the provided text, as the text describes a physical medical device, not an AI/ML system.

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