(88 days)
The Mammomat Fusion system generates digital mammographic images that can be used for screening and diagnosis of the breast under supervision of medical professionals. The Mammomat Fusion system is intended to be used in the same clinical applications as traditional film-screen mammography systems. The Mammomat Fusion system may also be used for additional diagnostic workup of the breast.
Mammomat Fusion is a floor-mounted full field digital mammography system for screening and diagnostic procedures on standing, seated or recumbent patients. The system consists of an examination stand with integrated microprocessor-controlled high-voltage generator as well as an optional radiation shield with a height-adjustable control desk with an integrated Acquisition Workstation (AWS). The moveable swivel arm on the examination stand contains the X-ray tube on the top end and the object table with the detector on the bottom end. The detector is a full field digital mammoqraphy detector.
The provided text describes the Siemens Mammomat Fusion Full Field Digital Mammography System and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, reported device performance metrics, or the details of a study designed to explicitly prove the device meets said acceptance criteria. Instead, it outlines the basis for substantial equivalence for FDA 510(k) clearance.
Here's an analysis of what can be extracted and what is missing based on your request:
Missing Information:
- A table of explicit acceptance criteria and specific reported device performance metrics. The document states "All test results were satisfactory" but does not quantify them.
- Sample size used for a test set in the context of proving acceptance criteria.
- Data provenance (e.g., country of origin, retrospective/prospective) for a test set.
- Number of experts and their qualifications used to establish ground truth for a test set.
- Adjudication method for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers improving with AI assistance. (This device is a mammography system, not an AI CAD system, so such a study would not be expected in this context).
- Details of a standalone (algorithm only) performance study. (Again, this is a hardware system, not an AI algorithm).
- The type of ground truth used (pathology, outcomes data, etc.) for any specific performance study related to acceptance criteria.
- Sample size for a training set. (This pertains to AI/machine learning, which is not the primary focus of this submission for a hardware device).
- How ground truth for a training set was established.
Information that can be inferred or is directly stated (though not in the format you requested for acceptance criteria):
1. Acceptance Criteria and Reported Device Performance (Inferred/General)
The document primarily relies on "substantial equivalence" to predicate devices and compliance with recognized standards.
| Acceptance Criteria (Inferred from standards and predicate comparison) | Reported Device Performance (General Statement in document) |
|---|---|
| Safety and Essential Performance: Adherence to IEC 60601-1:2005 (General requirements), IEC 60601-1-2 (Electromagnetic compatibility), IEC 60601-1-3 (Radiation protection). | "All test results were satisfactory." |
| "Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition, the Mammomat Fusion is continually monitored and if an error occurs, the system functions will be blocked and an error message will be displayed." | |
| "Siemens adheres to recognized and established industry practice and all equipment is subject to final performance testing." | |
| Mammographic Imaging Performance: Compliance with IEC 61223-3-2:2007 (Acceptance tests - Imaging performance) and IEC 60601-2-45:2011 (Particular requirements for mammographic equipment). | "All test results were satisfactory." |
| "The performance data of the Mammomat Fusion are compared to the GE Senographe DS as they have same physical detector characteristics." | |
| "The subject device has the same or better performance data as the secondary predicate." | |
| "The detector technology has been changed to Cesium Iodide technology. The performance of the detector has been compared to the secondary predicate the GE Senographe DS and the results of the non-clinical tests provide evidence of substantial equivalence to the secondary predicate." | |
| Risk Management: Compliance with ISO 14971:2007. | "Risk Analysis" performed as a quality assurance measure. |
| Software Life Cycle: Compliance with IEC 62304:2006. | "Requirement Specification Reviews," "Design Reviews," "Integration testing (System verification)" performed. |
| Biological Evaluation: Compliance with ISO 10993-1:2009. | (Not explicitly detailed as performance, but compliance implied by "All test results were satisfactory" and adherence to standards.) |
2. Sample Size for Test Set and Data Provenance:
- Not specified. The document mentions "Clinical and Non-clinical testing was conducted in accordance with the 'Guidance for industry and FDA Staff: Class II Special Control Guidance Document: Full-Field digital Mammography System,' (issued on March 27, 2012) and 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' (issued August 6, 1999)." These guidances would outline typical testing requirements, but the specifics for this particular submission's test set (e.g., number of images, patients, type of breast density, etc.) are not provided. The data provenance is also not mentioned.
3. Number of Experts and Qualifications for Ground Truth:
- Not specified. No mention of expert consensus or qualifications for a test set's ground truth. The submission focuses on device performance data compared to predicates and adherence to technical standards, not diagnostic accuracy studies with expert review.
4. Adjudication Method:
- Not applicable/Not specified. Not relevant to the type of device performance testing described (primarily technical and safety compliance).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is typically performed for Computer-Aided Detection (CAD) or AI systems where human reader performance is a direct outcome measure. The Mammomat Fusion is a hardware imaging system, and the submission does not describe an MRMC study comparing human readers with and without AI assistance from this device.
6. Standalone Performance Study:
- Yes (for technical parameters). The document claims "The subject device has the same or better performance data as the secondary predicate" and that "The performance of the detector has been compared to the secondary predicate the GE Senographe DS." This implies standalone technical performance testing (e.g., image quality metrics like spatial resolution, contrast-to-noise ratio, detective quantum efficiency related to the detector technology change from Selenium to Cesium Iodide TFT). However, the specific metrics and quantitative results are not provided in this summary.
7. Type of Ground Truth Used:
- Technical Benchmarks / Predicate Device Performance. For the technical performance aspects, the "ground truth" seems to be established through measurements against recognized technical standards (e.g., IEC standards for imaging performance, safety) and direct comparison to the physical detector characteristics of the GE Senographe DS predicate device. It is not an assessment of diagnostic accuracy against pathology or outcomes data.
8. Sample Size for Training Set:
- Not applicable/Not specified. This pertains to AI/machine learning model training. The Mammomat Fusion is a digital mammography system (hardware and associated control/processing software), not an AI algorithm requiring a training set in the typical sense.
9. How Ground Truth for Training Set Was Established:
- Not applicable/Not specified. See point 8.
§ 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.