(59 days)
Delta 32 and Delta 32 TACT® are intended to be used for diagnostic digital spot and 3D imaging, and optionally for digital stereotactic breast biopsy. Delta 32 and Delta 32 TACT® are intended to be used with the base mammographic system Diamond. However, a PC workstation of Delta 32 and Delta 32 TACT® can also be used as stand-alone for viewing images taken by Delta 32 and Delta 32 TACT®. The TACT® add-on provides means for digital 3D spot imaging using 2D projection images acquired with the system.
Delta 32 and Delta 32 TACT® is a mammographic diagnostic digital mammography spot and 3D imaging system, which can also be used for digital stereotactic breast biopsy. The base system is the Diamond mammographic system (#K955411), on which the Delta 32 and Delta 32 TACT® is installed. The images are acquired by a CCD camera identical to our Delta 32 (#K002472). The needle guiding system is the same than previously, Cytoguide biopsy unit (#K885020). A PC workstation receives images and computes the necessary needle coordinates for Cytoguide unit. The PC also performs the optional TACT® 3D reconstruction identically to the Delta 32 TACT® system described in (#K002472). The PC workstation can also be used as stand-alone for viewing digital mammography spot and 3D images taken by Delta 32 and Delta 32 TACT®.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Delta 32 with optional add-on TACT® device:
Acceptance Criteria and Device Performance Study for Delta 32 with optional add-on TACT®
The evaluation for the diagnostic use of the Delta 32 and Delta 32 TACT® was based on a clinical study comparing the subjective image quality of the digital system to screen and diagnostic film systems. The study used a Likert scale from +4 (digital image absolute better) to -4 (film image absolute better).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria (e.g., "The average Likert score must be greater than X"). However, the performance indicated by the statistical significance (p
§ 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.