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The Flexible Suturing System with Anchors (FSSA) is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons or joint capsules to the suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Flexible Suturing System with Anchors (FSSA) includes anchors, a pre-strung single common repair suture serially connecting the anchors in an array and an individual locking suture associated with each anchor (except the first anchor in the array) for selectively locking the repair suture relative to each anchor after tensioning the repair suture to form a tensioned stitch with a just prior implanted anchor in the array. The implanted array of anchors with a continuous set of anchor-to-anchor single suture stitches creates a seam-like attachment akin to a sewing machine construct. Each anchor of the FSSA is a monolithic injection molded body. An ancillary delivery instrument is utilized to create a bone hole and insert each anchor.

The provided text is a 510(k) Summary for a medical device (Flexible Suturing System with Anchors - FSSA) and details about its regulatory clearance. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device through performance testing.

It does not contain the information requested in your prompt regarding acceptance criteria for an AI/ML device, a study that proves the device meets those criteria, or details related to ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance typical for AI/ML device submissions.

The document describes a traditional medical device (suture anchor system) and its performance testing to ensure structural integrity and function, not an AI/ML system. Therefore, I cannot extract the specific information you've asked for about AI/ML device acceptance criteria and studies from this text.

Here's why I can't fulfill your request based on the provided input:

• Device Type: The device is a "Flexible Suturing System with Anchors (FSSA)," which is a physical orthopedic implant and related tools, not an AI/ML-based diagnostic or treatment aid.
• Performance Data: The "Performance Data" section lists "Suture Characterization, Insertion Testing, Pullout Testing, Fatigue Testing and Repair Suture Slippage Testing, as well as sterility assurance." These are all mechanical and material property tests relevant to an implantable device, not AI/ML model performance metrics like sensitivity, specificity, AUC, human-in-the-loop performance, etc.
• No Mention of AI/ML: There is no mention of algorithms, machine learning, artificial intelligence, image analysis, diagnostic interpretation, or any other AI/ML related concepts in the document.

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