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510(k) Data Aggregation
(88 days)
HYDROFERA FEMORAL WICK
The absorbent dressing is indicated for use in hip arthroplasty.
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This document is a 510(k) clearance letter from the FDA for a device called "Hydrofera Femoral Wick." It does not contain any information about acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, rather than being cleared based on a specific performance study against pre-defined acceptance criteria.
Therefore, I cannot provide the requested information from this document.
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