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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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