(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.
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916-342-4133 FAX: 916-343-
DEC - 5 1996
20 September 1996
510(k) SUMMARY
The 510(k) summary information required by CFR 807.92 is as follows :
- A . Classification name: Pin, fixation, smooth
Common/usual name: Fixation wire, fixation pin, nail, rod, and others
Proprietary name: Humerus Wires
- B. Substantial equivalence: Applied Osteo Systems System the Humerus, True/Flex IM Rod for Radius, and Ulna (K902264, K913949), Richards Ender Pins (K811002), O'Tec Corporation and ( K905341 Rush Corporation Pins and Onyx K903261, respectively), and others.
- The Humerus Wires device is C. Device description: an internal wire fixation device to be used in the fixation of humeral fractures.
- D. The Humerus Intended use: Wires device is intended to be implanted in the humerus for and/or internal fixation of fractures reconstruction of the humeral bone.
- E. Technological characteristics: The Humerus Wires
3407 Bay Avenue · Chico, California 95973 · USA
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device is similar to predicate devices in its design, function, and intended use.
The device is similar to certain predicates which do not utilize a locking screw, but it is unlike predicates which do utilize such a locking component.
The Humerus Wires device is manufactured from materials presently and/or previously utilized in FDA-cleared medical devices.
Submitted, FERGUSON MEDICAL FDA Establishment Registration Number 2937794
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Frank Ferguson Official Correspondent
§ 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.