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The OSSIO® Pin Product Family is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace) in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

OSSIOfiber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, ostectomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace) in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The OSSIOfiber® devices are made of degradable poly (L-lactide-co-D, L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alphahydroxy acids that are metabolized by the body. 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 provided text is a 510(k) summary for the OSSIO® Pin Product Family, OSSIOfiber® Compression Screw, and OSSIOfiber® Trimmable Fixation Nail. This document primarily focuses on demonstrating substantial equivalence to predicate devices for expanding the indications for use to include children and adolescents.

Therefore, this document does not contain the acceptance criteria or a study proving the device meets those criteria in the format typically associated with AI/ML-based device performance evaluations. The information provided is for a traditional medical device (fixation pins, screws, and nails) where the performance is assessed through non-clinical data (toxicological risk assessment, chemical characterization, and mechanical performance testing) comparing it to predicate devices.

Based on the provided text, I cannot complete the requested table or answer the questions related to AI/ML device performance studies because the document pertains to a traditional medical device and not an AI/ML diagnostic or therapeutic device.

Here's an analysis of why the requested information is absent:

• No AI/ML Component: The devices described are physical implants (pins, screws, nails) made of degradable materials. There is no mention of any software, AI, or machine learning component.
• Performance Evaluation Method: The substantial equivalence argument is based on:
  • Identical/Similar Intended Use: Expanding the age range for existing indications.
  • Material Composition: Degradable poly (L-lactide-co-D, L-lactide) (PLDLA) reinforced with continuous mineral fibers.
  • Design Characteristics: Similar to predicate devices.
  • Manufacturing and Sterilization Methods.
  • Principles of Operation.
  • Non-Clinical Data: Toxicological risk assessment, chemical characterization, and mechanical performance testing (where new worst-case scenarios were not identified).
• Lack of Study Design for AI/ML: There are no details about test sets, data provenance, ground truth establishment by experts, adjudication methods, or MRMC studies because these are not relevant to the type of device being cleared.

In summary, the provided document describes a traditional medical device clearance, not an AI/ML-enabled device. Therefore, the information required to fill out the table and answer the questions regarding acceptance criteria and performance study details for an AI/ML device is not present.

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