(223 days)
The UAS is designed for use in the fragmentation, emilsification and aspiration of soft tissue in the following surgical specialties: Neurosurgery, Gastrointestinal and affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Gynecology, Orthopedic Surgery.
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This document is an FDA 510(k) clearance letter for the UAS Ultrasonic Aspirator System, dated December 9, 1997. It explicitly states that the device is determined to be "substantially equivalent" to predicate devices marketed before May 28, 1976.
Based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The letter is a regulatory approval document confirming substantial equivalence, not a detailed technical report of a clinical study or performance evaluation. The typical information requested in your prompt (e.g., acceptance criteria, test set details, ground truth, MRMC studies) is usually found in the 510(k) submission itself or related study reports, which are not part of this clearance letter.
Therefore, I cannot populate the table or answer the specific questions about studies, sample sizes, or ground truth based solely on the provided text. The letter only indicates the device is cleared for marketing based on substantial equivalence, and lists the intended uses.
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