(505 days)
BIOFEATHER: biopsy system must be used for histological biopsy on soft tissue.
AVANGARDE: biopsy system must to be used for histological biopsy on soft tissues.
COX: the Co-Axial introducer needle mod. COX must be used when multiple biopsies of soft tissue are required.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the New Medax Biopsy Systems. It states that the device is "substantially equivalent" to legally marketed predicate devices. This type of document does not contain the acceptance criteria or details of a study proving the device meets specific performance criteria.
The FDA 510(k) process is primarily focused on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials to establish new performance metrics. Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is typically not found within a 510(k) clearance letter.
To fully answer your questions, one would generally need to refer to a separate clinical study report or performance testing documentation submitted as part of the 510(k) application, which is not included in this letter.
Therefore, I cannot provide the requested information based solely on the text provided.
§ 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.