(43 days)
Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system. The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion.
The Contrast Enhanced Digital Mammography (CEDM) Option used with the Selenia Dimensions 2D Full Field Digital Mammography System (FFDM) is an imaging option, referred to as dual energy imaging. The Selenia Dimensions was designed to support dual energy imaging. A CEDM Duel Energy Subtracted Image (CEDM image) acquisition consists of two 2D images, taken in sequence and in the same breast compression. The first image is a standard 2D FFDM image, as is acquired during conventional FFDM imaging. The kVp range used is typically 25 to 33 kVp and the rhodium and silver filters are the conventional ones used in this kVp range. This is referred to as the 'low energy' image. Following the low energy acquisition, a second image is acquired. This will be referred to as the 'high energy' image, and it uses a copper filter and a kVp range of 45 to 49 kVp. A weighted subtraction method is then used to subtract the contents of the low energy image from the high energy image. The two images are acquired in rapid succession to minimize the potential of patient motion that can create structural noise and can degrade image contrast. The low energy image together with the subtracted image is used clinically to evaluate the patient.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) premarket notification for a Contrast Enhanced Digital Mammography (CEDM) system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.
The 510(k) summary mentions:
- Summary of Testing: "Dual energy images captured, saved and/or transmitted by the Selenia Dimensions 2D FFDM conform with ACR/NEMA Digital Imaging Communications in Medicine version 3.0." and "Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820." These are general statements about compliance with standards and regulations, not specific performance metrics or a detailed clinical study for efficacy or accuracy.
- Comparison with Predicate Devices: It states that the device and predicate have "the same intended use, general configuration, principles of operation, and similar operating parameters," which is central to substantial equivalence.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text, as this information is not present.
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.