(107 days)
The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
The Aspire HD Plus and Aspire HD-s are integrated FFDM systems combining an X-ray system made by Fujifilm with Fujifilm's a-Se detector and Acquisition Workstation (AWS). The Aspire HD Plus and Aspire HD-s create digital mammography images by direct capture of x-ray energy using the a-Se detector. The detector is a Fujifilm design utilizing an exclusive dual layer a-Se scintillator with Direct Optical switching circuitry to acquire image data and transfer images to the AWS for automated post processing, technologist preview and QC, and subsequent transmission to hard copy printers, diagnostic workstations and archiving systems. The Aspire HD Plus and Aspire HD-s provide automated compression and three AEC modes.
The Aspire HD Acquisition Workstation (FDR 2000AWS) includes an off the shelf personal computer, the application software, Windows 7 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.
Here's a breakdown of the acceptance criteria and study information for the Fujifilm Aspire HD Plus and Aspire HD-s digital mammography systems, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document focuses on establishing substantial equivalence to a predicate device (FUJIFILM Aspire HD (FDR MS-1000) (K110729)) rather than presenting a formal table of specific, quantitative acceptance criteria with corresponding performance metrics for the proposed devices. Instead, it states that the devices meet the requirements through a comparison of imaging characteristics and a clinical image attribute review.
Here's an interpretation based on the information provided:
| Acceptance Criteria Category | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Technological Characteristics | "The technological characteristics of the devices are similar as demonstrated by the comparison of imaging characteristics such as MTF, Noise Analysis, DQE, CNR, Phantom testing, etc." |
| Non-Clinical Testing | Compliance with FFDM 510(k) Guidance document for: Sensitometric Response, Spatial Resolution, Noise Analysis, Signal-to-Noise Ratio Transfer - DQE, Dynamic Range, Image Erasure and Fading, Repeated Exposure Test, AEC Performance, ACR MAP Phantom Testing, Contrast Detail Phantom Testing, Patient Radiation Dose Testing, and Breast Compression system Testing. |
| Clinical Image Quality | "The Aspire HD Plus provides sufficiently acceptable quality for mammographic use." (This is stated to apply to both proposed devices due to identical imaging geometry and components.) |
| Indications for Use (IFU) | Same IFU as the predicate device: screening and diagnosis of breast cancer, intended for use in the same clinical applications as traditional screen-film mammography systems. |
| Safety & Efficacy | "no new safety or efficacy issues other than those already identified with the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Six (6) image sets per exposure mode of screening and diagnostic cases.
- Data Provenance: Not explicitly stated, but clinical image attribute reviews typically involve retrospective analysis of images. The document does not specify the country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated, but described as "independent mammographic radiologists."
- Qualifications of Experts: "independent mammographic radiologists." Specific years of experience are not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The document only mentions a "clinical image attribute review" by independent radiologists. It does not detail if there was a consensus process, independent reads followed by adjudication, or similar methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study mentioned is an image attribute review for image quality, not a comparative effectiveness study of human readers with vs. without AI assistance.
- Effect Size: Not applicable, as an MRMC study was not detailed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- Standalone Study: No, this device is a complete Full-Field Digital Mammography X-ray System, not an AI algorithm. The performance evaluation is for the entire imaging system.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the clinical image attribute review, the "ground truth" was the subjective assessment of "sufficiently acceptable quality for mammographic use" by independent mammographic radiologists. This is closer to expert consensus on image quality rather than pathology, outcomes data, or directly diagnosing disease. For the non-clinical tests (MTF, DQE, etc.), established physical phantom measurements and engineering standards were used.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. These are hardware medical devices (digital mammography systems), not AI algorithms that are "trained" on a dataset in the typical machine learning sense. The "development" would involve engineering and design, but not a distinct "training set" like for AI.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there isn't a training set in the context of an AI algorithm. The system's design and engineering parameters are based on established physics principles and clinical requirements for mammography.
§ 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.