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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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The WirelessMired FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film /screen or CR systems may be used. The FDR D-EVQ is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Fujifilm's FDR D-EVO Flat Panel Detector System (DR-ID600) is a portable digital detector system that acquires and digitizes x-ray exposures from standard radiographic systems. It is designed to be used in any environment that would typically use a radiographic cassette. It can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid exams.

The FDR D-EVO FPD system is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (Csl)). The new submission is being submitted for the same FDR D-EVO FPD system to seek the clearance of the pediatric indication for use.

Here's a breakdown of the acceptance criteria and study information for the Fujifilm FDR D-EVO Flat Panel Detector System (DR-ID600), based on the provided text:

Acceptance Criteria and Device Performance

The provided document (a 510(k) summary) doesn't explicitly list specific quantitative "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, or image quality metrics with thresholds). Instead, it states the device conforms to voluntary standards and provides acceptable diagnostic capability and image quality at reasonably low dose levels for pediatric use. The "reported device performance" is qualitative and based on expert evaluation.

Study Details

1. Sample size used for the test set and data provenance:

   • Test Set Sample Size: The document states that images were acquired "using phantoms that mimicked the pediatric subgroups." It does not provide a specific numerical sample size (e.g., number of phantom images or specific phantom types) for this test set.
   • Data Provenance: The data was generated through laboratory testing using phantoms. The country of origin is not explicitly stated, but the submission is from FUJIFILM Medical Systems U.S.A., Inc. This was a prospective study as it involved acquiring new images for the evaluation.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Number of Experts: Singular: "a pediatric radiologist."
   • Qualifications: "with experience in evaluating patient images and images of pediatric phantoms."

3. Adjudication method for the test set:

   • The document mentions evaluation by "a pediatric radiologist," implying no multi-reader adjudication method (e.g., 2+1 or 3+1). It appears to be a single-reader evaluation.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • No. The document describes an image quality evaluation by a single pediatric radiologist using phantoms. It does not mention an MRMC study or a comparison of human readers with vs. without AI assistance. The device itself is a flat panel detector, not an AI-assisted diagnostic tool in the sense of providing algorithmic interpretations for comparison with human readers.

5. If a standalone study (i.e., algorithm only without human-in-the-loop performance) was done:

   • This question is not directly applicable in the typical sense for this type of device. The FDR D-EVO is a hardware component (a flat panel detector) that acquires images, not an algorithm that interprets them. The "performance" being evaluated here is the image quality and diagnostic capability derived from the detector's output, which is then assessed by a human expert. The study essentially is a standalone evaluation of the device's capability to produce images suitable for diagnostic interpretation across pediatric subgroups.

6. The type of ground truth used:

   • The ground truth was established through expert consensus/evaluation by a pediatric radiologist evaluating images from phantoms designed to mimic pediatric subgroups. The phantoms themselves provide a known "truth" (e.g., structures, densities) which the radiologist assesses in the acquired images for diagnostic capability and image quality.

7. The sample size for the training set:

   • The document does not mention a training set. This device is a digital X-ray detector, and its primary function is image acquisition, not complex image analysis or AI interpretation that would typically require a training set in the context of machine learning. The focus of the submission is on hardware performance and image output suitability.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set is mentioned or implied for this device's function.

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Synapse 3D Base Tools is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning. Synapse 3D Base Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, CR, US, NM, PT, and XA, etc.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Synapse 3D Base Tools provides several levels of tools to the user:

• Basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal / oblique / curved Multi-Pianar Reconstructions (MPR), Maximum (MIP), Average (RaySum) and Minimum (MinIP) Intensity Projection, 4D volume viewing, image fusion, image subtraction, surface rendering, sector and rectangular shape MPR image viewing, MPR for dental images, creating and displaying multiple MPR images along an object, time-density distribution, basic image processing, CINE, measurements, annotations, reporting, printing, storing, distribution, and general image management and administration tools, etc.
• Tools for regional segmentation of anatomical structures within the image data, path definition through vascular and other tubular structures, and boundary detection.
• Image viewing tools for modality specific images, including CT PET fusion and ADC image viewing for MR studies.

The SYNAPSE 3D Base Tools software is medical application software running on Windows Server 2008 installed on commercial general-purpose Windows-compatible computers. SYNAPSE 3D Basic Tools software is connected through DICOM standard to other medical devices such as CT, MR, CR, US, NM, PT, XA, etc. and to PACS systems storing data generated by these medical devices. Image data obtained from these devices are used for display, image processing, analysis, etc. SYNAPSE 3D Base Tools cannot be used to interpret Mammography images.

SYNAPSE 3D Base Tools can be integrated with Synapse Workstation (cleared by CDRH via K051553 on 07/07/2005) and can be used as a part of a SYNAPSE system.

SYNAPSE 3 D Base Tools Version 3.0 expands upon the applications listed in Synapse 3D Basic Tools, #K101662 with the addition of the below new applications. In addition, new and improved algorithms are listed in Section 11.1.4.

• Slicer
  Slicer creates multiple cross-sectional images along an object such as spine with MPR processing using CT or MR data. The user can adjust the location of reference lines manually to obtain desired slices.

• Combination
  Combination can concatenate separated series data acquired for a single body into one single series.

• Dental MPR
  Dental MPR creates a cross-sectional image along the specified line on teeth with MPR, including CPR, processing using head CT data.

• ADC Viewer
  ADC Viewer accepts MR diffused weighted images, calculates ADC (Apparent Diffusion Coefficients) and EADC (Exponential ADC) values for each pixel using the known equations, and displays color mapped ADC and EADC images.

The provided text describes the Synapse 3D Base Tools device and its regulatory clearance but does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and a definitive study proving the device meets them.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states: "Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed." However, it does not provide a detailed table of these criteria nor specific quantitative performance metrics like sensitivity, specificity, or accuracy. It only generically mentions "system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test, as well as the test for risk mitigation method."

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

This information is not provided in the document.

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

This information is not provided in the document. The document refers to "trained medical professionals" as the intended users of the tools, but not as part of a formal ground truth establishment process for testing.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A MRMC study is not explicitly mentioned or described. The document focuses on the device's functional and performance testing in isolation, rather than its comparative effectiveness with or without human readers.

6. Standalone Performance Study

The document describes "system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test," which implies standalone testing of the algorithm's performance on various tasks (segmentation, measurement). However, specific metrics (e.g., accuracy percentages, dice scores) are not reported.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated. It can be inferred that for "segmentation accuracy" and "measurement accuracy," some form of reference standard (e.g., manual segmentation by experts, known physical measurements) would have been used.

8. Sample Size for the Training Set

This information is not provided in the document. The document mentions "new and improved algorithms" but does not detail any machine learning model training or the dataset used.

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

This information is not provided in the document.

Summary based on available information:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and confirming that internal testing (verification, validation) against predefined requirements was successful. It states that "Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed." However, it lacks the granular detail about the specific acceptance criteria, test methodologies, sample sizes, expert involvement, and quantitative results that your request outlines. This level of detail is typically found in the full submission or predicate device documentation, not usually in the brief 510(k) summary filed with the FDA.

Therefore, while the device "meets the acceptance criteria" as stated by the submitter, the document does not provide the specific study details nor the acceptance criteria themselves that would allow for a comprehensive answer to your questions.

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The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), 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 HD is an integrated FFDM system combining an X-ray system made by Siemens with Fujifilm's a-Se detector and Acquisition Workstation (AWS). The Aspire HD creates digital mammography images by direct capture of x-ray energy using the a-Se 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 provides automated compression and one AEC mode.

The Aspire HD Acquisition Workstation (FDR 1000AWS) includes an off the shelf personal computer, the application software, either Microsoft Vista or Windows 7 Operating System, a Smegapixel 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 t
• . 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 provided text regarding the FUJIFILM Aspire HD Full-Field Digital Mammography X-ray System, focusing on the acceptance criteria and the study that proves the device meets them.

It's important to note that the provided documents are a 510(k) Summary and the FDA's Substantial Equivalence letter. These documents typically focus on demonstrating equivalence to a predicate device rather than presenting a detailed clinical study with explicit acceptance criteria and corresponding performance metrics for an AI algorithm. Since this device is a digital mammography system itself and not an AI-based diagnostic tool, the interpretation below will reflect the information provided for such a system.

Acceptance Criteria and Device Performance

The provided text does not contain a typical "acceptance criteria table" with specific quantitative metrics (e.g., sensitivity, specificity, AUC) and corresponding reported performance values that would be expected for an AI diagnostic device. Instead, for a digital mammography system, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through technical comparisons and a qualitative clinical image attribute review.

Implicit Acceptance Criteria and Reported Performance (for a digital mammography system):

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Six (6) image sets of screening and diagnostic cases.
   • Data Provenance: Not explicitly stated, but clinical cases are implied. The country of origin and whether the data was retrospective or prospective are not mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: "independent mammographic radiologists" (number not specified, but plural indicating more than one).
   • Qualifications: "independent mammographic radiologists." Specific experience (e.g., 10 years) is not detailed.

3. Adjudication method for the test set:

   • The document states an "image attribute review was conducted by independent mammographic radiologists." The specific adjudication method (e.g., 2+1, 3+1) is not provided. It seems to have been a collective review or consensus among the independent radiologists.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study involving AI assistance was not done. This document pertains to a device (mammography system), not an AI algorithm intended to assist human readers. The clinical review was to assess the image quality of the Aspire HD system itself, not its impact on human reader performance with or without AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No, this is not applicable. The Aspire HD is a full-field digital mammography X-ray system, not a standalone algorithm. The "performance" being assessed is the system's ability to produce diagnostically acceptable mammographic images.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the image attribute review was based on the expert opinion/consensus of independent mammographic radiologists regarding the "sufficiently acceptable quality for mammographic use" of the images. It was not based on pathology or outcomes data in the typical sense of a diagnostic accuracy study.

7. The sample size for the training set:

   • Not applicable. This document describes a medical imaging device (hardware and integrated software for image acquisition), not a machine learning model that relies on a "training set" in the context of AI. The system itself undergoes design and engineering, but doesn't have a data-driven "training set" like an AI algorithm would.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for this device in the context of AI development.

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FUJIFILM Unity SpeedSuite X-Ray System is Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

The FUJIFILM DR Unity SpeedSuite is a stand-alone X-ray exposure system comprised of a U- arm (manufactured by Sedecal) that incorporates the following: Fuji's image reader equipped with HD Linescan technology, Fuil's CR/DR Console (IIP), and Sedecal's X-ray source and U-Arm system (Verso). Since both are paired, the height and angle can be flexibly changed while maintaining their positional relationship. This system enables you to make an exposure not only at supine or upright position but also at any other desired positions. Images taken by the Unity system are sent to Fuii's IIP (CR/DR Console) to be processed. There is an automatic collimator made by Huestis attached to the tube head. The x-ray tube is manufactured by Toshiba

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided documents, the "acceptance criteria" for the FUJIFILM Unity SpeedSuite are primarily based on demonstrating substantial equivalence to a predicate device, the Sedecal URS LP X-Ray Units with Digital Detector (K042876). The "performance" is implicitly compared through a feature-by-feature assessment rather than explicit quantitative metrics of diagnostic accuracy.

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

The provided documentation does not mention a clinical test set with human patients or images for performance evaluation. The study focuses on demonstrating substantial equivalence through a comparison of technical specifications and the fact that the proposed device combines three already cleared devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No clinical evaluation with expert ground truth establishment is described in these documents. The "ground truth" for this 510(k) submission is the technical specifications and cleared status of the predicate and component devices.

4. Adjudication Method

Not applicable. No clinical evaluation or expert review process requiring adjudication is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in these documents. The submission focuses on substantial equivalence based on technical specifications and the combination of previously cleared components, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not conducted or reported. The device is a hardware system for X-ray acquisition and processing, not an AI algorithm for image interpretation.

7. Type of Ground Truth Used

The "ground truth" implicitly used for this submission is regulatory clearance and established performance of predicate and component devices, along with technical specifications and bench/standards testing results of the proposed device itself. There is no mention of pathology, expert consensus on patient images, or outcomes data.

8. Sample Size for the Training Set

Not applicable. This device is a diagnostic X-ray system, not an AI image analysis algorithm that requires a training set of images.

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

Not applicable. As above, there is no AI algorithm requiring a training set for this device.

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Synapse Image Visualization Software MIP/MPR Obliquus enables the display of 3D (MIP/MPR) visualization of CT and MR studies. Typical users are radiologista, technologists and clinicians.

Obliquus is an integrated Maximum Intensity Projection (MIP) and Multi-Planar Reformatting (MPR) software package intended to be used with Fuji Synapse Workstation Software Version 3.1.1 and higher. This software is designed to be used by radiologists, clinicians and referring physicians to acquire, process, review, store, print and distribute DICOM compliant image studies utilizing standard PC hardware. Obliquus offers similar user interface and image manipulation functionality as was cleared in Synapse Workstation software version 3.1.0.

The Obliquus software enables the user to display MPR visualization of CT or MRI studies in Synapse. Once opened in Synapse, the images can be presented in the following viewers:

MPR Viewer: Visualizes a study image of the selected series in the following four types of plane images:

(1) Original view is the original CT or MRI study image.

(2) Reformatted A view represents visualization of the original view orthogonal to the original study plane (i.e., if original image is axial, then Reformatted A will be of the coronal plane).

(3) Reformatted B view represents visualization of the original view orthogonal to the original study plane (i.e., if the original image is axial, then Reformatted B will be of the sagittal plane).

(4) Oblique view shows a plane image from any direction specified by the user.

Compare Viewer: Compare viewer consists of four windows and up to four series that can be displayed for visual comparison. The Compare viewer functions are as follows:

• . Synchronously display images of each series
• Make synchronous display setting which includes adjusting slice position and changing . synchro unit
• . Switch among 3 orthogonal plane images
• Set rendering mode and slab thickness .
• Display patient study and image information .
• . Toggle with the MPR viewer

Stereo Viewer: Presents images for stereopsis, particularly for Magnetic Resonance Angiography (MRA) MIP images. The Stereo viewer's functions include:

• . Rotating and displaying plane images horizontally
• . Setting image display format
• . Setting rendering mode, slab thickness and projection angle interval
• . Display patient, study and image information
• . Toggle with the MPR viewer

Images can be saved either as bitmap files or to the Synapse server.

The provided text is a 510(k) summary for the FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D MIP/MPR Image Visualization Software OBLIQUUS. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically understood for performance metrics like accuracy, sensitivity, or specificity.

The document focuses on regulatory clearance based on substantial equivalence, rather than a detailed performance study with quantitative metrics. The "Testing" section broadly refers to "Functional testing" as part of the product development process, but provides no specifics on methodology, results, or acceptance criteria.

Therefore, for the requested information, many fields will be marked as "Not provided in the document."

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not provided in the document.
• Data provenance: Not provided in the document. The document mentions "CT or MRI studies" as input for the software but does not specify the origin or nature of the data used for any testing.
• Retrospective or Prospective: Not provided in the document.

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

• Number of experts: Not provided in the document.
• Qualifications of experts: Not provided in the document.

As there is no detailed performance study described for the device's visualization capabilities, the concept of "ground truth" and expert adjudication in the context of diagnostic accuracy, which these questions imply, is not applicable or detailed in this 510(k) summary. The summary focuses on functional equivalence to a predicate device for image display and manipulation.

4. Adjudication Method for the Test Set

• Adjudication method: Not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs. Without AI Assistance

• MRMC study done: No. This document describes an image visualization software, not an AI software intended to assist human readers in a diagnostic capacity or a comparative effectiveness study of its impact on reader performance.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable/Not provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

• Standalone study done: Not explicitly described in the context of performance metrics for image visualization. The "Testing" section refers to "Functional testing" but doesn't detail a standalone performance study with specific outcomes. The device itself is an "Image Visualization Software," implying human interaction is integral to its intended use, rather than an autonomous algorithm making diagnoses.

7. The Type of Ground Truth Used

• Type of ground truth: Not provided in the document. (Given the nature of the device as image visualization software, "ground truth" in the diagnostic sense is not the primary focus of this submission, which emphasizes functional equivalence).

8. The Sample Size for the Training Set

• Sample size for training set: Not applicable/Not provided. This software is described as an image visualization tool, not a machine learning or AI-based diagnostic tool that would typically involve a "training set" for model development.

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

• How ground truth for training set was established: Not applicable/Not provided. (See point 8).

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Fuji Synapse Workstation Software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with Fuji Synapse PACS. The Fuji Synapse Workstation is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse Workstation can process medical Images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities.

The Synapse Workstation may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible, displays. Synapse does not provide spatial frequency enhancement, dynamic range control, or mulli-objective frequency image processing for DICOM MG "For Presentation" mammography images.

The Synapse Workstation provides viewing and manipulation of radiological data including images, reports, patient status, and clinical information.

The workstation utilizes a folder structure providing easy navigation and organization of images, studies, documents, etc. that most users are familiar with from Microsoft Explorer and other Windows applications. The workstation contains workflow scripting and hanging protocols designed to maximize productivity and allow each user to tailor the workstation operation to their individue looging

In addition to common image manipulation functions such as windowlevel and windowlydth variation, magnification, density value, etc., the Synapse Workstation provides more advanced image processing, including processing of CR and CT images.

The provided text is a 510(k) summary for the Fuji Synapse Workstation Software. This type of document focuses on establishing substantial equivalence to predicate devices rather than providing detailed studies proving specific performance metrics against defined acceptance criteria for AI/ML-based devices.

Therefore, the document does not contain the information requested regarding acceptance criteria for device performance, specific studies demonstrating the device meets those criteria, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or training set details.

The device description primarily highlights its functions for viewing and manipulating radiological data, workflow, and image processing capabilities, comparing them to predicate devices like the Fuji CR Console and Amicas Light Beam Workstation. The "Safety Information" section discusses hazard analysis and compliance with standards like DICOM, but not performance-based acceptance criteria in the context of AI/ML evaluation.

The 510(k) summary concludes with a statement of substantial equivalence to its predicate devices for its intended use, which is typical for a device of this type and era (2005).

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