(54 days)
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.