(56 days)
The Planmed Cytoguide is a mammography stereotactic biopsy system which is attached to Planmed Sophie Classic mammographic x-ray unit. The Cytoguide system is a removable attachment and is intended for obtaining tissue samples, for delivering localized treatment and for placement of a radio-opaque marking to assist subsequent procedures, especially for breast lesions too small to be palpable.
The Planmed Cytoguide is a mammography stereotactic biopsy system which is attached to Planmed Sophie Classic mammographic x-ray unit. The Cytoguide system is a removable attachment.
I am sorry, but the provided text from the FDA 510(k) notification for the Planmed Cytoguide does not contain information on the acceptance criteria, device performance study details, or ground truth establishment. The document is primarily a notification of substantial equivalence and outlines the intended use of the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this 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.