(140 days)
The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be inter hard copy film or soft copy workstation.
With Biopsy Option:
The InSpect feature for MAMMOMAT Revelation with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.
MAMMOMAT Revelation is a floor-mounted full field digital mammography system for screening, diagnostic and biopsy procedures on standing, seated or recumbent patients.
The system consists of an examination stand with X-ray generator, a gantry with tube housing assembly and mammography support table including detector, and an acquisition workstation with a radiation shield. The MAMMOMAT Revelation comes with a variety of compression plates and a biopsy attachment for diagnostic adjunct procedures.
The MAMMOMAT Revelation features an updated detector (LMAM 2v2), an upgrade to the MS Windows 10 operating system, the capability to do contrast enhanced mammography and tomosynthesis guided biopsy.
The Siemens MAMMOMAT Revelation device was evaluated in non-clinical bench tests. Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Objective | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Detector characteristics | Ensure non-inferiority to predicate | Same or better than predicate | Passed |
| Dual energy imaging | Ensure diagnostic image quality | As described in System Test Record Dual Energy (Appendix E) | Passed |
| Targeting accuracy (biopsy) | Ensure accuracy of the biopsy device | The needle tip must be no more than +/-1 mm in x, y, z direction from the selected target point. | Within 1 mm of target |
2. Sample Size and Data Provenance for Test Set:
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the bench tests. These tests are non-clinical and conducted in a laboratory setting.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
Not applicable. The tests described are bench tests focused on technical performance metrics (detector characteristics, image quality, targeting accuracy) and do not involve human readers or expert-established ground truth in the traditional sense of a clinical study. The "ground truth" for these tests would be the established physical and technical specifications or reference measurements.
4. Adjudication Method for Test Set:
Not applicable. As these are bench tests, an adjudication method for human interpretation is not relevant. The results are based on direct measurement and comparison against defined technical criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document describes non-clinical bench tests. There is no mention of an MRMC comparative effectiveness study involving human readers.
6. Standalone (Algorithm Only) Performance:
The document describes tests of the physical device's characteristics and its features. It does not specifically detail a "standalone" algorithm performance study without a human-in-the-loop, as the device is a medical imaging system. The "algorithm" here would refer to the internal image processing and AEC calculations, which are components of the system test.
7. Type of Ground Truth Used:
The ground truth for these non-clinical tests is based on:
- Established specifications and performance of the predicate device (for detector characteristics).
- Defined technical standards and internal system test records (for dual energy image quality).
- Physical measurements against a known target in a phantom (for targeting accuracy).
8. Sample Size for Training Set:
Not applicable. The document describes tests for a medical imaging device, not an AI or machine learning algorithm that typically requires a separate training set. The "MAMMOMAT Revelation" is a physical mammography system.
9. How Ground Truth for Training Set Was Established:
Not applicable, as there is no mention of a separate training set for an AI algorithm.
§ 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.