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The Inion OTPS Biodegradable Fixation System is generally intended for maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.

Specific indications:

• Fractures and osteotomies of the malleoli .
• Ankle fractures

The Inion OTPS™ Biodegradable Fixation System is made of resorbable polylactic acid / trimethylenecarbonate copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. The Inion OTPS™ Biodegradable Fixation System implants gradually lose their strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.

The provided text describes a medical device, the Inion OTPS™ Biodegradable Fixation System, and its regulatory clearance. However, it does not include information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance in a clinical or diagnostic setting.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and shared intended use, which is a common path for 510(k) clearances. This means that instead of new clinical performance studies, the clearance relies on the established safety and effectiveness of similar, already marketed devices.

Therefore, I cannot provide the requested information. The text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, qualifications of experts, or adjudication method for a test set.
3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
4. Data on standalone device performance in a diagnostic context.
5. Details on the type of ground truth used for performance validation.
6. Sample size for a training set or how ground truth for a training set was established, as this would typically apply to AI/software performance studies, which is not the nature of this device's clearance.

The "study" mentioned is general "mechanical testing" to demonstrate substantial equivalence, not a clinical performance study with specific acceptance criteria and ground truth.

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