(210 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 interpreted by either 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 system software to VC20, including new detector software for faster system calibration, and improvements to the contrast enhanced mammography feature and biopsy workflow. Improvements include adjustments to the image processing for contrast enhanced mammography to present a more homogeneous image. The biopsy attachment was complemented with a spacer plate to be used for easier access to the biopsy region.
Here's a summary of the acceptance criteria and study details for the MAMMOMAT Revelation device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Detector Characteristics | Same or better than predicate (as described in FDA's Class II Special Controls Guidance Document: Full-Field Digital Mammography System) | Passed |
| Dual Energy Imaging | Image quality equivalent to images acquired with VC10 | Passed |
| Targeting Accuracy (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 |
| Biopsy Procedure with Spacer Plate | Same results with and without spacer plate | Passed |
| Cleaning of the Spacer Plate | According to AAMI TIR 30 and AAMI ST58 | Passed |
| Clinical Image Evaluation (FFDM) | Acceptable quality for mammographic usage (substantially equivalent to predicate device images) | Determined to be substantially equivalent to predicate device |
2. Sample Size and Data Provenance for Test Set
- FFDM Clinical Image Evaluation: The image sets consisted of 8 FFDM cases (including one case with diagnostic images).
- DBT Biopsy Cases: Three DBT biopsy cases with the new spacer plate.
- Contrast Enhanced Mammography Cases: 4 contrast enhanced mammography cases.
- Data Provenance: Not explicitly stated, but given that the study was conducted by Siemens and submitted to the FDA, it is likely internal data, possibly from multiple sites contributing to the case collection. It is considered retrospective in the sense that existing cases were used for evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Images for dual energy imaging were "evaluated by Radiologists." The clinical image evaluation was reviewed by "expert radiologists." The exact number of radiologists is not specified, nor are their specific qualifications (e.g., years of experience), but they are described as "expert radiologists."
4. Adjudication Method for the Test Set
- The text does not specify a formal adjudication method (like 2+1 or 3+1 consensus). It simply states that images were "evaluated by Radiologists" and "reviewed by expert radiologists."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done to evaluate human reader improvement with AI assistance. The study described focuses on demonstrating the substantial equivalence of the device's image quality and performance compared to its predicate, primarily through technical tests and a clinical image evaluation by radiologists. This submission does not appear to involve an AI component that would assist human readers in interpretation.
6. Standalone (Algorithm Only) Performance Study
- A standalone algorithm performance was not the primary focus of the clinical evaluation described here. The evaluation of FFDM cases and dual energy images involved human radiologists determining image quality and equivalence. Some tests, like "Detector characteristics" and "Targeting accuracy," could be considered standalone performance evaluations of specific aspects of the device's capabilities.
7. Type of Ground Truth Used
- For the clinical image evaluations, the ground truth was established by expert consensus/review from radiologists. The "acceptable quality for mammographic usage" and "image quality equivalent to images acquired with VC10" were determined by these experts.
- For technical tests like "Targeting accuracy," the ground truth was established by physical measurement (e.g., measuring the needle tip's deviation from the target point with a phantom).
8. Sample Size for the Training Set
- The document describes modifications to the MAMMOMAT Revelation device, including updated system software (VC20) with new detector software and improvements to image processing. It does not explicitly mention a "training set" in the context of machine learning or AI algorithm development for the device itself. Therefore, the concept of a training set for an AI algorithm is not directly applicable to the information provided regarding this device's submission.
9. How the Ground Truth for the Training Set Was Established
- As a training set for an AI algorithm is not explicitly mentioned or relevant in the provided context, the method for establishing its ground truth is not applicable. The improvements mentioned (e.g., "improvements to the contrast enhanced mammography feature and biopsy workflow") suggest engineering and software development rather than machine learning model training.
§ 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.