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The EXPERT - Flexible Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting. The EXPERT - Flexible Joint Fixation System are intended to provide fixation during the healing process following:

EXPERT FAST - SYNDESMOSIS and EXPERT FAST DUAL:

Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

EXPERT ACL and EXPERT ACL II:

Fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, these models are offered for Anterior Cruciate Ligament (ACL) Repair.

EXPERT FAST - CORACOID PLATE and EXPERT FAST- AC:

Specifically, these models are intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The EXPERT - Flexible Joint Fixation System was designed for fixation, being used as a biomechanical structure to simulate a support pillar distributing the tensions in the suture wire or tape. The plates are manufactured in titanium alloy conforming to ASTM F136. The sutures are manufactured from UHMWPE. The devices are sold sterile and are single use. The EXPERT - Flexible Joint Fixation System is a line extension to the EXPERT - Joint Fixation System consisting of new models.

The provided text describes a medical device, the "EXPERT - Flexible Joint Fixation System," and its 510(k) summary for FDA clearance. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical or algorithmic performance study would.

The document discusses equivalence to predicate devices based on "submitted testing data" but does not detail the nature of these tests, specific acceptance criteria, or the results. It mentions:

• Performance Data: "Based on submitted testing data, the proposed EXPERT - Flexible Joint Fixation System is equivalent to the Arthrex ACL TightRope (K100652) and TightRopeTM Acromioclavicular (K052776) predicate devices." (Page 6)
• Conclusion: "Any differences between the proposed device and the predicate device are considered minor and do not raise new or different questions concerning safety or effectiveness." (Page 6)

This refers to engineering testing or benchtop studies to demonstrate the mechanical equivalence or biocompatibility of the device's components to previously cleared predicate devices, rather than a study evaluating diagnostic or prognostic capabilities of an AI/ML algorithm.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to a study proving the device meets these criteria in the context of AI/ML or clinical performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this particular device based on the provided text.

The information requested, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training set ground truth was established, is not present in the provided FDA 510(k) summary for the EXPERT - Flexible Joint Fixation System. This is typical for a 510(k) for a physical medical device like a fixation system, which focuses on substantial equivalence to predicate devices through technical, material, and mechanical comparisons, rather than AI/ML algorithm performance.

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