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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.

Device Description

The ASPIRE Cristalle is an integrated FFDM system combining an X-ray system made by Fujifilm with Fujifilm'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 photo-conversion layer with TFT Readout 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 Cristalle provides powered compression and three AEC modes.

The ASPIRE Cristalle Acquisition Workstation (FDR 3000A WS) 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the ASPIRE Cristalle, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided document (K133972 510(k) Summary) states that the ASPIRE Cristalle was evaluated against the predicate device, FUJIFILM Aspire HD Plus (K121674). The acceptance criteria were based on a comparison of imaging characteristics and a clinical image attribute review, concluding that the device provides "sufficiently acceptable image quality for mammographic use."

While explicit numerical acceptance criteria values are not presented in a table format, the document implies that the ASPIRE Cristalle's performance met the standards set by the predicate device and relevant guidance documents.

Acceptance Criteria Category	Reported Device Performance (ASPIRE Cristalle compared to Aspire HD Plus)
Technological Characteristics	- Same Indication For Use (IFU)
	- Generates digital mammographic images for screening and diagnosis of breast cancer.
	- Intended for use in the same clinical applications as traditional screen-film mammography systems.
Detector Technology	- Same amorphous selenium digital x-ray detectors integrated into the gantry.
Pixel Type	- Uses hexagonal pixels (vs. square pixels in HD Plus). This is a difference, but the conclusion states overall similarity.
X-ray Stands and Generators	- Same x-ray stands.
	- Extremely similar generators.
Imaging Characteristics (Non-Clinical Testing)	- Similar characteristics demonstrated across: MTF, Noise Analysis, DOE, CNR, Phantom testing.
	- Tested in accordance with FFDM 510(k) Guidance: 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, Breast Compression system Testing.
Clinical Image Quality	- Provides sufficiently acceptable image quality for mammographic use.

2. Sample Size and Data Provenance

Test Set Sample Size: "six (6) image sets of screening and diagnostic cases" were reviewed for the clinical image attribute review.
Data Provenance: Not specified, but implied to be clinical images. No country of origin is mentioned. The study is retrospective, as it is a review of existing image sets.

3. Number of Experts and their Qualifications for Ground Truth

Number of Experts: Independent mammographic radiologists. The exact number is not explicitly stated.
Qualifications: "Independent mammographic radiologists." No specific years of experience are provided, but their specialization in mammography is stated.

4. Adjudication Method for the Test Set

The document states a "clinical image attribute review was conducted by independent mammographic radiologists." It does not specify a formal adjudication method like 2+1 or 3+1. It implies a consensus-based review or individual assessments leading to the overall conclusion of "sufficiently acceptable image quality."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study evaluating the improvement of human readers with AI assistance versus without AI assistance was reported. This submission is for a digital mammography system, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a full-field digital mammography system, not an algorithm being evaluated in a standalone capacity. The performance described relates to the image acquisition system itself.

7. Type of Ground Truth Used

The ground truth for the clinical image attribute review was based on the expert consensus/opinion of independent mammographic radiologists regarding the "sufficiently acceptable image quality for mammographic use."

8. Sample Size for the Training Set

Not applicable. The document describes a digital mammography system, not a machine learning algorithm that requires a training set. The "training" for the system would be its design and engineering parameters, not a dataset in the AI sense.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set for an AI algorithm. The device's performance is established through non-clinical testing and a clinical image attribute review, comparing it to a predicate device.

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