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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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SenoBright HD is an extension of the existing indication for diagnostic mammography with Senographe Pristina. The SenoBright HD application shall enable contrast enhanced breast imaging a dual energy technique. This imaging technique can be used as an adjunct following mammography and ultrasound exams to help localize a known or suspected lesion.

This submission is proposing a software update to SenoBright HD consisting of an improvement of the existing "recombination" algorithm with the New Image Recombination Algorithm (NIRA) by adding a local estimation of breast thickness in the images recombination to account for the non-uniformity of the breast thickness, and by compensating for potential patient movement between the 2 CESM acquisitions (Low Energy and High Energy).

SenoBright HD (K172404) is the name of Senographe Pristina FFDM system allowing to perform Contrast Enhanced Spectral Mammography (CESM) application.

The CESM acquisition technique consists in acquiring two images (one High Energy and one Low Energy) in sequence and under the same breast compression after patient injection with an iodinated contrast media. The two images are then recombined through a post-processing algorithm.

This design change is a software and labeling only option, compatible with SenoBright HD installed base and does not require any hardware modification on the Senographe Pristina platform.

Here's a breakdown of the acceptance criteria and study details for the SenoBright HD device with the New Image Recombination Algorithm (NIRA), based on the provided document:

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner (e.g., "must achieve X% sensitivity"). Instead, the document focuses on demonstrating non-inferiority or improvement compared to the predicate device (SenoBright HD K172404) and showing clinical acceptability. The performance is reported in terms of assessments made by radiologists.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Clinical Image Evaluation (Initial Acceptability): 10 images
  • Clinical Image Evaluation (Comparative): 50 clinical images
• Data Provenance: The document does not explicitly state the country of origin for the clinical data used in the studies. Given GE Healthcare's presence in France (as per the submitter's address), it is plausible the data could originate from there or other international sites. The data is described as "clinical images," implying retrospective data from a clinical setting. It is not stated whether it was prospective or retrospective, but the description "clinical images" often implies retrospective collection for such comparative studies.

3. Number of Experts and Qualifications

• Number of Experts: 3 independent MQSA-qualified radiologists used for both clinical image evaluations.
• Qualifications: "MQSA-qualified radiologists." MQSA (Mammography Quality Standards Act) qualification indicates that these radiologists meet specific federal standards for interpreting mammograms in the United States, including training, experience, and continuing education requirements. The specific years of experience for each expert are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1, 3+1). It states that the evaluations were "performed by 3 independent MQSA-qualified radiologists." This suggests that each radiologist independently assessed the images, and the reported percentages (97%, 99%, 98%) likely represent the proportion of cases where at least two out of three (or possibly all three) agreed on the assessment, or an aggregatetion of individual assessments, but the specific consensus/adjudication rule is not detailed.

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

• A comparative effectiveness study was performed as a form of reader study, but it wasn't a "human readers improve with AI vs without AI assistance" MRMC study in the sense of AI assisting the human reader.
• Instead, this study compared the quality of images generated by the new algorithm (NIRA) against the quality of images generated by the previous algorithm (Predicate SenoBright HD), both assessed by human readers.
• Therefore, there's no direct "effect size of how much human readers improve with AI vs without AI assistance" as the AI (NIRA) is the image generation method being evaluated, not an assistance tool for the human reader's diagnostic performance. The human readers are evaluating the output of the AI.

6. Standalone Performance (Algorithm Only)

The document primarily focuses on the output quality of the algorithm as perceived by human readers, rather than a quantifiable "standalone" diagnostic performance (e.g., sensitivity/specificity for detecting lesions). The phantom testing is a form of standalone performance evaluation for image quality metrics, but not for diagnostic accuracy in a clinical context.

7. Type of Ground Truth Used

The ground truth for the clinical image evaluations was effectively the expert consensus/assessment of the image quality metrics (contrast uptake visibility, artifact visibility, overall image quality) by the 3 MQSA-qualified radiologists. There is no mention of pathology or outcomes data being used as the clinical ground truth for lesion presence/absence for diagnostic performance evaluation, as the study was focused on image quality assessment.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for training the New Image Recombination Algorithm (NIRA). This is typical for premarket notifications where the focus is on verification and validation of changes rather than the internal development details of the algorithm itself.

9. How Ground Truth for Training Set was Established

The document does not provide any information on how the ground truth for the training set (if any was used for supervised learning of NIRA) was established. As NIRA is described as an "evolution" of an existing recombination algorithm, it might involve engineering improvements rather than a machine learning model that requires a labeled training set in the typical sense. It states NIRA accounts for "non-uniformity of the breast thickness" and compensates for "potential patient movement," suggesting algorithmic improvements based on physical principles and image characteristics rather than purely data-driven supervised learning.

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The Pristina Serena Bright option provides the three-dimensional location of target lesions, using information obtained from stereotactic pairs of two-dimensional X-ray images acquired with Contrast Enhanced Spectral Mammography (CESM) under the same breast compression. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as: vacuum assisted biopsy, core biopsy, pre-surgical localization (e.g. hookwire), and fine needle aspirations (FNA).
CESM-Biopsy application is indicated for patients with suspicious lesions only seen with certainty when imaged with a contrast agent or that do not have a definite correlate on mammography or ultrasound.

Pristina Serena Bright is a Biopsy System for Senographe Pristina. It is an additional software option that builds upon the Pristina Serena device (GE Healthcare Stereotaxy biopsy option for Senographe Pristina platform). Pristina Serena was cleared on May 14, 2018 (K173576).
Pristina Serena Bright enables biopsy medical application to be done using Contrast Enhanced Spectral Mammography images.
The Pristina Serena Bright add-on includes the following items: Software: A new software version for the Senographe Pristina platform which includes software to manage the Pristina Serena Bright option. Labeling for the CESM Biopsy Medical application.
Pristina Serena Bright option is compatible with previously installed Senographe Pristina systems. Pristina Serena Bright does not require any hardware modification on the Senographe Pristina platform. The hardware that was cleared on Pristina Serena (K173576) was also not modified.

The provided text describes the regulatory submission for GE Healthcare's "Pristina Serena Bright" and mentions substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria or a specific study proving the device meets those criteria with performance metrics, sample sizes for test sets, ground truth establishment, or MRMC study results as requested.

The document states that "Pristina Serena Bright has successfully completed required design control testing per GE Healthcare's quality management system." It also mentions "Non-Clinical Data – Biopsy accuracy testing: verification of the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)." However, it does not provide the specific acceptance criteria for this accuracy (e.g., within X mm), nor the quantitative results of this testing.

Therefore, I cannot provide the complete answer to your request. I can only extract what is present in the document.

Based on the provided text, here's what can be gathered, and what is missing:

Missing Information:

• A table of specific acceptance criteria (e.g., accuracy must be X mm) and reported device performance against those criteria.
• Sample sizes used for the test set.
• Data provenance (country of origin, retrospective/prospective) for the test set.
• Number of experts used to establish ground truth for the test set.
• Qualifications of those experts.
• Adjudication method for the test set.
• Whether an MRMC comparative effectiveness study was done, and if so, the effect size.
• Specific quantitative results from the standalone performance (e.g., numerical accuracy metrics).
• The type of ground truth used (beyond "verification of the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)").
• Sample size for the training set.
• How the ground truth for the training set was established.

Information Extracted (albeit limited):

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in quantitative terms within the provided text. The document refers to "Biopsy accuracy testing" for "verification of the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)."
   • Reported Device Performance: "The testing demonstrated that Pristina Serena Bright performs according to specifications and functions as intended." No specific performance metrics (e.g., mean accuracy, standard deviation) are provided.

2. Sample sized used for the test set and the data provenance: Not specified in the provided text. The testing is referred to as "Non-Clinical Data – Biopsy accuracy testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. The ground truth appears to be based on the physical position of a needle or target in a phantom/bench test, rather than human expert interpretation of images for ground truth.

4. Adjudication method for the test set: Not applicable based on the "Non-Clinical Data – Biopsy accuracy testing" described, which suggests a physical measurement validation rather than a reader study on images.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not indicated. The focus of the provided text is on demonstrating "substantial equivalence" of the device through technical and performance testing against a predicate, particularly in terms of image quality and biopsy accuracy, rather than clinical efficacy studies involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The "Biopsy accuracy testing" appears to be a standalone performance test of the system's ability to accurately guide a needle to a target, based on the stereotactic principles. However, specific metrics are not provided. The device provides "guidance for a variety of minimally invasive or interventional procedures," implying human involvement in the procedure, but the accuracy testing itself seems to be of the system's geometric capability.

7. The type of ground truth used:

   • For the "Biopsy accuracy testing": Ground truth was established by verifying "the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)." This implies a physical, measurable ground truth (e.g., using a phantom or controlled setup).
   • For image quality and dose tests: Comparison to "SenoBright HD" images at similar dose levels.

8. The sample size for the training set: Not mentioned.

9. How the ground truth for the training set was established: Not mentioned.

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