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The Omnia Medical Trauma Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The Omnia Medical Trauma screws are manufactured from Ti-6A1-4V ELI per ASTM F136. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy.

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device.

The document pertains to the 510(k) premarket notification for Omnia Medical Trauma Screws, which are physical medical devices (metallic bone fixation fasteners), not an AI/ML software device.

Therefore, I cannot provide an answer that includes:

1. A table of acceptance criteria and reported device performance (for an AI/ML device)
2. Sample size and data provenance for a test set (for an AI/ML device)
3. Number and qualifications of experts for ground truth (for an AI/ML device)
4. Adjudication method (for an AI/ML device)
5. Multi-reader multi-case (MRMC) comparative effectiveness study data (for an AI/ML device)
6. Standalone performance data (for an AI/ML device)
7. Type of ground truth (for an AI/ML device)
8. Sample size for the training set (for an AI/ML device)
9. How ground truth for the training set was established (for an AI/ML device)

The document focuses on the substantial equivalence of the physical trauma screws to a predicate device based on intended use, technological characteristics, and engineering rationale, rather than performance data from clinical studies in the way you'd expect for an AI/ML algorithm.

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