(57 days)
The intendended use of the Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device is to hold the needle in the stereotactic device for precise location of the needle tip in the needle biopsy of the breast. This device is intended to be used with the Lorad Stereotactic Device only.
Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device
The provided text ({0} and {1}) is a 510(k) clearance letter from the FDA for the "Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device." This document approves the device for marketing based on its substantial equivalence to a predicate device.
However, the provided text does not contain any information about acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter is a regulatory approval, not a technical report or scientific publication detailing a study about the device's performance. It confirms that the FDA reviewed the 510(k) submission, which would have included such information, but the specific details of that submission are not present in the provided text.
Therefore, I cannot fulfill your request as the necessary information is not available in the input.
§ 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.