(18 days)
To obtain percutaneous core biopsy samples from soft tissue 10 obtain perculations core bropsy surves, kidney, prostate, and culturs of sach organs as awnen used for breast blopsy, the product is for diagnosis only.
Automated Core Biopsy Device
The provided text is an FDA 510(k) clearance letter for the "Automated Core Biopsy Device" and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter primarily states that the device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory matters such as general controls, manufacturing practices, and labeling, but does not include technical details about the device's validation or performance.
Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided input.
§ 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.