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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.

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.

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.

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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.

The ASPIRE Cristalle (K133972) (FDR MS-3500) is an integrated FFDM system combining an X-ray system made by Fujifilm with Fujifilm's a-Se detector and FDR-AWS3000 acquisition workstation (AWS). The system creates digital mammography images by direct capture of x-ray energy using a detector of 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, technologists' preview and QC, and subsequent transmission to hard copy printers, diagnostic workstations and archiving systems. The ASPIRE Cristalle provides powered compression and AEC modes.

The subject of this premarket notification is a software upgrade to the predicate device. The hardware is unchanged. The software is unchanged with the exception that the subject device incorporates improved grayscale and frequency processing software named Dynamic Visualization II for Mammography (DVIIm) in the FDR-AWS3000 image acquisition software.

DVIIm image processing consists of EDR2m and MFP2 image processing.

• . Exposure Data Recognition 2 for mammography (EDR2m) = the EDR2m algorithm analyzes image data and identifies various anatomic structures using a statistical estimation method as opposed to original EDR's histogram analysis method. EDR2m determines the parameters to optimize brightness and contrast of the image based on the analysis result.
• . Multi-Object Frequency Processing 2 (MFP2) - MFP2 optimizes the brightness, contrast and sharpness of the image using parameters determined by the EDR2m processing. MFP2 uses additional low frequency tables and a combination of automatic and preset dynamic range control operations.

DVIIm takes full advantage of the wide range of image data acquired with the high sensitivity of Fujifilm's advanced detector technologies. DVIIm provides improved contrast and density stability throughout the entire exposure region and achieves improved visibility across a wide range of breast compositions including the presence of implants.

Here's an analysis of the provided text regarding the ASPIRE Cristalle device, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a software upgrade to an existing device (ASPIRE Cristalle with DVIIm image processing). The "acceptance criteria" here are framed within the context of demonstrating substantial equivalence to the predicate device and meeting regulatory guidance for Full-Field Digital Mammography (FFDM) systems. The reported performance refers to the outcomes of the clinical image attribute review.

• Phantom Testing (Section 8 Physical Laboratory Testing) | Applicable phantom testing results have been provided in accordance with the guidance. (Specific numerical acceptance criteria for phantom testing are not detailed in this summary, but the general statement indicates compliance). Additionally, "ASPIRE Cristalle maintains the confidentiality, integrity and availability in accordance with Section 6 of the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". |
  | Premarket Notification Guidance for FFDM Systems (March 27, 2012):
• Clinical Image Attribute Review (Section 6)
  Implicit Criterion: Provide sufficiently acceptable image quality for mammographic use across various breast compositions and exposure modes. | A clinical image attribute review was conducted by independent mammographic radiologists.
  Conclusion: "The ASPIRE Cristalle provides sufficiently acceptable image quality for mammographic use."
  Specifically, DVIIm "provides improved contrast and density stability throughout the entire exposure region and achieves improved visibility across a wide range of breast compositions including the presence of implants." |
  | General Safety and Performance Standards (e.g., IEC 60601 series, IEC 62304, DICOM v3):
• Compliance with relevant medical electrical equipment, software, and imaging communication standards. | The ASPIRE Cristalle meets the applicable basic safety and essential performance requirements for Medical Electrical Equipment, including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-45, IEC 62304, and DICOM Version 3.
  Hazard Analysis: Indicates the device is of moderate concern, consistent with guidance, and introduces "no new safety or efficacy issues other than those already identified with the predicate device." |
  | Software Development Lifecycle (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices):
• Comprehensive software development, verification, and validation activities. | Software verification and validation have been performed by unit, integration, and system tests throughout design verification and validation phases. (This implies adherence to established software quality processes, which are an acceptance criterion for software-driven medical devices). |
  | Substantial Equivalence:
• Same Indications for Use (IFU) as the predicate device. | The predicate and proposed devices have the same indications for use (IFU). (Explicitly stated). |

Note: The FDA 510(k) process primarily evaluates "substantial equivalence" to a legally marketed predicate device, rather than setting distinct, quantitative "acceptance criteria" for novel performance. The acceptance criteria here are derived from the regulatory guidance documents referenced and the conclusion of equivalence based on the provided data.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Six (6) image sets of screening and diagnostic cases.
• Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. The cases were reviewed by independent mammographic radiologists, implying they were existing or newly acquired images for the purpose of the review.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not explicitly stated as a specific number. The document mentions "independent mammographic radiologists" in the plural, so it was more than one.

• Qualifications of Experts: "Independent mammographic radiologists." Specific experience levels (e.g., "10 years of experience") are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). It states that the review was conducted by "independent mammographic radiologists" who concluded that the image quality was "sufficiently acceptable for mammographic use." This suggests a consensus or independent evaluation without a formal multi-reader adjudication process detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a formal MRMC comparative effectiveness study that quantitatively measures "how much human readers improve with AI vs without AI assistance" was not described.
• The study was a clinical image attribute review assessing the quality of images produced by the device, not a reader study evaluating diagnostic performance with or without an AI assist. While it mentions "improved visibility" across breast compositions, this is a qualitative claim based on the image attribute review, not a quantitative measure of reader improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, implicitly. The DVIIm software is an "image processing" algorithm. The clinical image attribute review assessed the output of this algorithm (the images themselves) in terms of their quality for mammographic use. While radiologists were involved in evaluating the images, the study was not testing the algorithm as a diagnostic assist to the radiologists' decision-making. It was assessing the quality of the image produced by the algorithm.
• The "performance testing - bench: Applicable phantom testing results..." also represents a form of standalone testing of the system/algorithm's physical output and processing capabilities without human diagnostic interaction.

7. The Type of Ground Truth Used

• For the clinical image attribute review, the "ground truth" was expert consensus/opinion by "independent mammographic radiologists" regarding the acceptability of image quality for mammographic use.
• It's important to note this is not ground truth for disease diagnosis (e.g., pathology-confirmed cancer) but rather ground truth for the quality and suitability of the image for interpretation.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set of the DVIIm image processing software. It mentions that DVIIm image processing consists of EDR2m and MFP2, and describes their functions, but does not detail their development data.

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

The document does not provide information on how ground truth was established for the training set (if any) used for developing the DVIIm image processing software. It describes the algorithms (EDR2m and MFP2) but doesn't detail their training methodology or data. Image processing algorithms often rely on various image characteristics and properties rather than diagnostic "ground truth" derived from patient outcomes or pathology, but the specific methods are not mentioned here.

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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.

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.

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.

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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