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The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures

The OsteoCentric Bone Plate and Screw System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features nineteen (19) types of plates and bone screws for fixation that are locking or non-locking, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F138), and offered in various widths and lengths.

The provided text is a 510(k) summary for the OsteoCentric Bone Plate and Screw System. It details the device's characteristics, indications for use, and a comparison to predicate devices, but it does not contain information about an AI/ML-based medical device or any study proving a device meets acceptance criteria related to AI/ML performance.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these concepts are not discussed in this document. The document describes a traditional medical device (bone plates and screws) and relies on substantial equivalence to previously cleared predicate devices, primarily through engineering analysis and existing performance testing of those predicates (ASTM F543 and ASTM F382).

The 510(k) clearance process for this type of device does not involve the kind of performance studies (e.g., clinical trials, AI algorithm validation) that would generate the data you're asking about.

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