(35 days)
"Disposable needle for obtaining biopsies from Bone and Bone Marrow."
Not Found
I am sorry, but the provided text does not contain the information requested. The document is an FDA letter regarding the 510(k) clearance for a bone biopsy needle and includes sections on "Indications for Use." However, it does not detail any acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or a more detailed submission summary. Therefore, I cannot generate the requested table or answer the specific questions about the study.
§ 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.