(82 days)
CThe Gallini Atra-Cut Needle is used for fine bone biopsy and aspiration procedures.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Gallini Atra-Cut® Needle. It does NOT contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.
The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices, which allows it to proceed to market. It refers to a "510(k) notification of intent to market" which would have contained the technical details and performance data, but this specific document (the clearance letter) itself does not include that information.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies based only on the text you provided.
To answer your request, you would need the actual 510(k) submission document or a summary thereof, which typically includes the performance data and comparisons to predicate devices.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.