(62 days)
Adaptation for use on the Mammotest® System tables when the clinician wishes to use the Auto Suture ABBI* System for large core biopsy.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Mammotest® Adapter Driver." It acknowledges that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related information requested in the prompt.
The letter is a regulatory approval, not a technical report or a study summary. It confirms the device's clearance for marketing based on substantial equivalence, but it does not detail the technical performance studies that might have been submitted to support that claim.
Therefore, I cannot provide the requested table and study information based solely on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or the full 510(k) submission, which would contain the technical data and study details.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.