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OSSIOfiber™ Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.

The OSSIOfiber™ Compression Screws are cannulated bone screws made of degradable poly (Llactide-co-D. L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from minerals that are found in natural bone. As the OSSIOfiber™ implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber™ Compression Screws are supplied sterile, for single patient use only, and are available in several sizes: 26-60 mm long, and 3.5-6.5 mm diameter. The screws are partially threaded, cannulated design.

The OSSIOfiber™ Compression Screws are designed to be used with commonly available orthopedic surgical tools such as ISO 5853/ISO 9714 compatible instrumentations.

The provided text describes the OSSIOfiber™ Compression Screw and its substantial equivalence to a predicate device, focusing on non-clinical testing for mechanical properties and biocompatibility. It does not contain information about a study involving acceptance criteria related to device performance in an AI/software context.

Therefore, I cannot fulfill the request as it pertains to acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided document for this medical device.

The document focuses on the regulatory clearance process for a physical medical device (bone screw) based on demonstrating substantial equivalence through mechanical testing and biocompatibility assessment, not on a software or AI-driven device requiring performance metrics like sensitivity, specificity, or reader studies.

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