(19 days)
Needle Guides shall be single use only and are to be used by a mammographic x-ray specialist in a healthcare setting to aid in needle placement.
Needle Guide
This document is a 510(k) clearance letter from the FDA for a Needle Guide manufactured by Remington Medical, Inc. It explicitly states that the device is "substantially equivalent" to predicate devices, meaning it does not require a new study to prove its safety and effectiveness.
Therefore, the input does not provide information about:
- Acceptance criteria and reported device performance: Since it's a 510(k) clearance based on substantial equivalence, there are no specific performance acceptance criteria or study results presented in this document.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone studies, type of ground truth for test or training sets, or how ground truth was established. These are all elements of a de novo or PMA submission, not a 510(k) based on substantial equivalence.
The document essentially states that because a similar device is already on the market and the new device is substantially equivalent, it does not need to go through the rigorous testing and reporting described in your request.
§ 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.