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The INION OTPS™ BIODEGRADABLE DISTAL RADIUS PLATE implants are indicated for use in open reduction and internal fixation of fractures, and radiolunocarpal fusion of the distal radius in the presence of appropriate immobilization.

Inion OTPS™ Biodegradable Distal Radius Plate implants are indicated for use in open reduction and internal fixation of fractures, osteotomies, and radiolunocarpal fusion of the distal radius in the presence of appropriate immobilization. Inion OTPS 100 Biodegradable Distal Radius Plate implants are made of is made of resorbable polylactic acid / trimethylenecarbonate copolymers and it is provided in sizes typical to this application.

Inion OTPS™ Biodegradable Distal Radius Plate implants gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years.

Inion OTPS™ Biodegradable Distal Radius Plate implants are provided sterile to the user and is non-pyrogenic. The shelf life of the device is 3 years.

The provided document is a 510(k) summary for the Inion OTPS™ Biodegradable Distal Radius Plate. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about a study that establishes acceptance criteria for device performance or provides reported device performance data, especially in the context of AI/ML software.

The document discusses the mechanical properties and degradation profile of the Inion OTPS™ plate in relation to a predicate metallic device, but this is a comparison based on product specifications and potentially bench testing, not a clinical study involving specific acceptance criteria for performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.

The 510(k) process for medical devices like this typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish and meet specific performance acceptance criteria for a novel AI/ML application. The performance here refers to the physical properties and functional equivalence of the biodegradable plate to a metallic plate, not the diagnostic or predictive accuracy of a software.

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