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The Humerus Wires device is intended to be implanted in the humerus for internal fixation of fractures and/or reconstruction of the humeral bone.

The Humerus Wires device is an internal wire fixation device to be used in the fixation of humeral fractures.

I am sorry, but the provided text only contains basic descriptive and classification information about a medical device called "Humerus Wires." It is a 510(k) summary from 1996 for a fixation wire.

The document does not contain any information about:

• Acceptance criteria for performance.
• A study proving the device meets acceptance criteria.
• Reported device performance metrics.
• Sample sizes for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Types of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Therefore, I cannot fulfill your request for this specific document. This document is related to regulatory clearance (510(k)) and focuses on substantial equivalence to predicate devices, not detailed performance studies or AI-related metrics.

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