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Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits.

The material used to manufacture the bone plates is implant-quality 316L Stainless (ASTM Fric material used to manufacture (ASTM F-136). The plates are to be used with accompanying bone screws of the same material.

I am sorry, but the provided text from the FDA letter regarding the Vilex Bone Plate Systems does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) clearance letter, which states that the device is substantially equivalent to a legally marketed predicate device. This type of clearance focuses on equivalence rather than performance against specific acceptance criteria from a clinical study.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample sized used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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