(260 days)
The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
Dual energy procedures is an optional feature of the ASPIRE Cristalle that can capture images consecutively under two different tube voltage conditions during one compression, and then create and display a subtraction image of the two acquired images. This optional feature shall enable contrast enhanced breast imaging and is used as an adjunct following mammography. Dual energy procedures is not intended for primary screening or diagnosis.
The ASPIRE Cristalle (K173132) (FDR MS-3500) is an integrated FFDM system combining an X-ray system made by Fuiifilm's a-Se detector and Acquisition Workstation (AWS). The ASPIRE Cristalle creates digital mammography images by direct capture of x-ray energy using the a-Se detector. The detector is a Fujifilm design utilizing an a-Se photoconversion layer with TFT Readout circuitry to acquire image data and transfer images to the A WS for automated post processing, technologist preview and QC, and subsequent transmission to hard copy printers, diagnostic workstations and archiving systems. The ASPIRE Cristalle provides powered compression and three AEC modes.
The ASPIRE Cristalle Acquisition Workstation (FDR 3000AWS) includes an off the shelf personal computer, the application software, Windows Operating System, a 5megapixel portrait type monitor, and a hub. The hub transmits signals between the personal computer and control cabinet, and between the personal computer and exposure stand.
The AWS display primarily consists of three windows:
- . Patient Information Input window
- Exposure Menu Selection window ●
- . Study window.
The user may switch between these windows depending on the operation being performed. The X-ray control panel, which controls and observes the exposure stand, is always displayed in the lower part of each window. This allows setting the exposure conditions and confirming the radiation conditions on a single view.
This 510(k) submission introduces the optional feature of Dual energy procedures for the ASPIRE Cristalle. Dual energy procedures can capture images consecutively under two different tube voltage conditions during one compression, and then create and display a subtraction image of the two acquired images. This optional feature shall enable contrast enhanced breast imaging and is used as an adjunct following mammography. It should only be used with FDA approved contrast agents according to the manufacturer's instructions. The X-ray exposures must be performed after the contrast agent has diffused into the breast and before its washout, which is typically between 2 to 7 minutes after beginning of injection according to Clinical publications and/or the manufacturer's instructions. For the image acquisition in one direction, it takes about 25 seconds from the first X-ray exposure to the display of energy subtraction images.
The provided text describes the Fujifilm ASPIRE Cristalle (FDR MS-3500) device and its optional Dual Energy Procedures feature. The 510(k) summary explains that the device is substantially equivalent to a predicate device for standard mammography, and that the dual-energy feature was evaluated through non-clinical and limited clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the dual-energy feature in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating acceptable image quality and substantial equivalence.
| Aspect of Acceptance/Evaluation | Reported Device Performance | Comments |
|---|---|---|
| Image Quality (Clinical) | "produces images that are of acceptable quality for mammographic usage." | This is a qualitative assessment by experts. No specific quantitative metrics (e.g., SNR, contrast difference) are provided for "acceptable quality." |
| Substantial Equivalence (Non-Clinical) | "demonstrated substantial equivalence to the predicate device." | This refers to various physical and technical parameters of the system, not directly diagnostic performance. |
| Safety & Efficacy | "introduces no new safety or efficacy issues other than those already identified with the predicate device." | Assessed through hazard analysis and compliance with standards. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: 10 patient CEDM images were used for the clinical evaluation of the Dual Energy Procedures feature.
- Data Provenance: Not explicitly stated (e.g., country of origin). The text refers to "10 patient CEDM images," implying prospective or retrospective acquisition for the purpose of the study, but no details are given.
3. Number of Experts and Their Qualifications
- Number of Experts: Three (3)
- Qualifications: "MOSA qualified expert mammographic radiologists."
4. Adjudication Method
The text states that the clinical evaluation was "performed on 10 patient CEDM images by three (3) MOSA qualified expert mammographic radiologists." It does not specify an adjudication method like 2+1 or 3+1 for establishing ground truth or determining a consensus on image quality. It's implied the experts individually or collectively assessed acceptability, but the process is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed comparing human readers with AI vs. without AI assistance. The study described is a clinical evaluation of image quality performed by human readers on the new dual-energy images, not an AI-assisted interpretation study.
6. Standalone (Algorithm Only) Performance
The document does not describe a standalone performance study of an algorithm independent of human-in-the-loop performance. The dual-energy feature is described as enabling contrast-enhanced breast imaging and producing subtraction images for human interpretation, not for automated standalone diagnosis.
7. Type of Ground Truth Used
For the clinical evaluation of the dual-energy images, the ground truth was expert consensus (or individual expert assessment) on "acceptable quality for mammographic usage." There is no mention of pathology, long-term outcomes data, or other objective diagnostic ground truth being used to validate the accuracy of findings from these dual-energy images. The evaluation primarily focused on image quality for human interpretation.
8. Sample Size for Training Set
The document does not mention a training set or any machine learning algorithm for diagnostic interpretation in the context of the dual-energy feature. The Dual Energy Procedures feature is described as a method to capture and display subtraction images based on X-ray physics, not an AI-based diagnostic tool requiring a training set.
9. How Ground Truth for Training Set Was Established
Not applicable, as no training set for an AI/ML algorithm is described in the provided text for the Dual Energy Procedures feature.
§ 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.