(42 days)
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.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.