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The WISORB™ malleolar screw is intended for use in bone-to-bone fixation in the metaphyseal area, distal humerous, trochanteric area and in the ankle where the bone is dense.

The WISORB™ malleolar screw is intended primarily for internal fixation of fractures with minimal displacement commonly seen in fractures of the ankle and foot, such as, transverse fibular fractures at or distal to the ankle joint (Danis-Weber Type A); low spiral fractures of the lateral malleolus, avulsion fractures of the medial malleolus (Dyputren; Danis-Weber Type-B), avulsion fractures of the posterior malleolus (Volkman's Triangle). Other fractures that maybe suitable for treatment with the WISORB™ malleolar screw include distal ractures (Type Colles), which typically occur at the metaphyseal portion of the bone proximal to the extensor tendon sheaths.

The WISORB™ malleolar screw is not intended for use in and is contraindicated for:

• Fractures of cortical bone (diaphyseal area)
• Situations of active or potential infection or where patient cooperation cannot be guaranteed.

The WISORB™ malleolar screw is composed of 75% by wt (88% by volume) of the copolymer (L -co-D,L-lactide) (weight ratio 70:30), and 25% by wt (12% by volume) of sintered hydroxylapatite. The WISORB is a bioabsorbable, partially-threaded screw with a conical head and rounded bottom.

The WISORB™ has a single size with the following dimensions:

• i. Length 30 mm
• Thread diameter 4.5 mm ii.
• iii. Thread length 11.64 mm
• Shaft diameter 2.62 mm iv.
• Head diameter 6.75 mm v.
• Head depth 6.73 mm vi.

The provided text describes a medical device, the WISORB™ Malleolar Screw, and its 510(k) submission for FDA clearance. However, it does not contain information about acceptance criteria, device performance metrics, or a study detailing these aspects.

The document is a summary of the safety and effectiveness, focusing on establishing substantial equivalence to predicate devices, not on proving new performance metrics against specific acceptance criteria.

Therefore, for your request, I can only provide the information that is present in the document.

Here's what I can extract:

• 1. A table of acceptance criteria and the reported device performance: This information is not present. The document states that "In vitro laboratory, mechanical testing and animal studies have been submitted that support the equivalence of the WISORB™ malleolar screw to other predicate devices," but it does not specify any acceptance criteria or report performance metrics from these studies.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not present.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not present. The device is a physical screw, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. The device is a physical screw, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present. The document mentions "in vitro laboratory, mechanical testing and animal studies" were submitted, implying mechanical and biological outcomes were assessed, but specific "ground truth" establishment methods are not detailed.
• 8. The sample size for the training set: This information is not present.
• 9. How the ground truth for the training set was established: This information is not present.

In summary, the provided text is a 510(k) summary for a medical device (a absorbable screw) and focuses on demonstrating substantial equivalence to existing devices rather than presenting the results of a detailed performance study with defined acceptance criteria and statistical analysis.

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