(207 days)
The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under supervision of medical professionals.
Mammographic images can be interpreted by either hardcopy film or softcopy workstation.
Mammomat Inspiration is a floor-mounted mammography system for screening, diagnostic and biopsy procedures on standing, seated or recumbent patients.
The system consists of an examination stand with integrated. microprocessor-controlled, high-frequency generator as well as a radiation shield with an optional height-adjustable control desk in which the Acquisition Workstation (AWS) can be integrated. A swivel arm contains the X-ray tube on the top end and the object table with the detector on the bottom end.
The provided text is a 510(k) summary for the Siemens Mammomat Inspiration, a mammography system. This submission is for an updated version (VB30) compared to a predicate device (VB10). The document primarily focuses on demonstrating substantial equivalence to the predicate device, emphasizing that the core imaging components and algorithms remain unchanged.
Based on the information provided, here's an analysis of the requested points:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or report specific performance metrics for the Mammomat Inspiration VB30 in a format that would typically be used for a new medical device claiming improved diagnostic accuracy or a new clinical capability.
Instead, the submission focuses on demonstrating substantial equivalence to the predicate device (Mammomat Inspiration VB10). The key "performance" reported is that the imaging properties (TFT with pixel size and number and image processing algorithms) have not been modified and are identical to the predicate device. The new features ("Automatic Quality Control" and workflow improvements) are presented as optional and not impacting the fundamental image acquisition or processing for diagnostic interpretation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent imaging properties to predicate device (VB10) | X-ray generation and control used with the Mammomat Inspiration VB30 is identical to the Mammomat Inspiration with VB10. Detector TFT specifications, image processing algorithms remain unchanged. The Acquisition Workstation (AWS) is identical. |
| Safe and effective operation | 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. The system is continually monitored, and if an error occurs, functions will be blocked and an error message displayed. |
| Compliance with industry practice and regulations | Siemens adheres to recognized and established industry practice (to minimize electrical, mechanical and radiation hazards), and all equipment is subject to final performance testing. |
| No change in Indications for Use | The Mammomat Inspiration VB30 is intended for the same indications for use as the predicate Mammomat Inspiration VB10 (mammography exams, screening, diagnosis, and stereotactic biopsies). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention any test set, sample size, or data provenance related to a clinical study for the VB30 version to prove its diagnostic performance. The submission relies on the established performance of the predicate device (VB10) and the fact that the core imaging path has not changed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. No test set or related ground truth establishment is described for the VB30 in this submission.
4. Adjudication Method for the Test Set:
Not applicable. No test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document does not describe a MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The focus is on hardware and software equivalence for image generation and display, not an AI diagnostic aid.
6. Standalone Performance Study:
No. The document does not describe a standalone performance study of an algorithm without human-in-the-loop. The Mammomat Inspiration is an imaging system, not a diagnostic algorithm in this context.
7. Type of Ground Truth Used:
Not applicable. No clinical study involving ground truth for diagnostic performance is described for the VB30. The "ground truth" for this submission appears to be the functional and technical equivalence to the previously approved predicate device.
8. Sample Size for the Training Set:
Not applicable. The document does not describe any machine learning or AI models requiring a training set in the context of diagnostic performance. The "Automatic Quality Control" feature is mentioned, but its development method (e.g., if it uses machine learning and a training set) is not detailed.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As no training set is described for diagnostic purposes, the establishment of its ground truth is not relevant here.
§ 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.