(62 days)
For use in Screening Mammographic Imaging as a Specialty Paddle for Full Breast Compression as an alternative to conventional breast compression paddles.
The Advantage paddle is a breast compression paddle comprising of a rectangular tray-like structure of an FDA approved biocompatible material (Eastman Kodak PETG Copolyester #6763). The paddle has a flat section and a tilted section made possible by two-section construction. The first section of the paddle is foamed rigidly and is positioned near the patient's chest and extends about one inch away from the chest. In operation, this provides a vertically oriented force to the breast that tends to keep the breast tissue from being forced into the chest wall and provides a clearer film of the breast tissue adjacent the chest. The scond section is formed and structured to flex for the purpose of tilting the paddle downward to compress the nipple end of the breast in a steady position as the X-ray is taken. The "Advantage" paddle is mcant for use with an 18 x 24cm bucky. That is a standard size used in the industry
The provided document is a 510(k) summary for a breast compression paddle, not an AI/ML device. Therefore, it does not contain information related to acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML device.
The document discusses the substantial equivalence of the "Advantage Breast Compression Paddle" to a predicate device ("S.O.F.T. Paddle") based on design, materials, indications for use, and a comparison of construction and images. There is no performance data in the context of diagnostic accuracy, sensitivity, specificity, etc., that would be applicable to an AI/ML algorithm.
Therefore, I cannot provide the requested information for an AI/ML device based on this document.
§ 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.