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510(k) Data Aggregation
(29 days)
This device is used for the correction of hallux valgus (bunion) and repair of metatarsal, metacarpal and phalangeal fractures.
Titanium Compression Anchor System
The provided text is a 510(k) clearance letter from the FDA for a device called "Titanium Compression Anchor System". This document confirms that the device is substantially equivalent to a predicate device and can be marketed. It does not contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert qualifications for AI/ML device validation.
Therefore, I cannot extract the requested information from the provided text. The questions posed are relevant to AI/ML device submissions, which this document is not.
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(89 days)
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