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FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources.

FUJIFILM Synapse PACS Software provides toolsets for:

• Performing measurements on DICOM images
• Regional segmentation
• Importing and presenting data from modalities (DICOM and non-DICOM),
• Solving clinical calculations
• Creating and distributing structured reports

FUJIFILM Synapse PACS Software 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. It enables the display, comparison, fusion, and volume rendering of studies to aid in reading, interpreting, reporting, and treatment planning.

MIP, MPR Fusion, and volume rendering are not intended for mammography use. FUJIFILM Synapse PACS Software can be used to process FUJIFILM's DICOM MG "For Processing" images and also 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 for mammography.

The Synapse PACS is an enterprise-wide medical information and image management software that runs on standard "off-the-shelf" PC hardware and Software (OS, browser). Synapse is intended for communication, storage, display, manipulation, measurement, printing, and processing of images and information acquired from various medical imaging and information systems. As a Software as a Medical Device (SaMD), Synapse PACS performs these purposes without being part of a hardware medical device.

FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources.

FUJIFILM Synapse PACS Software provides toolsets for:

• Performing measurements on DICOM images
• Regional segmentation
• Importing and presenting data from modalities (DICOM and non-DICOM),
• Solving clinical calculations
• Creating and distributing structured reports

Here's a breakdown of the acceptance criteria and study details for the Synapse PACS (7.5) device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

The core performance study described pertains to the Bone Removal algorithm.

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

Note: The acceptance thresholds for DSC and 95% HD were determined by reviewing existing bone removal models in scientific literature.

Study Details Proving Device Meets Acceptance Criteria

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

• Test Set Sample Size: 72 patients, each with one image collected.
• Data Provenance: The document states patient demographic distribution from "Midwest" (20 patients), "Southwest" (20 patients), and "Southeast" (32 patients) regions. This indicates the images were collected from various regions within the United States. The document does not explicitly state whether the data was retrospective or prospective, but the description of "collected images" and established ground truth often implies a retrospective study using an existing image archive.

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

• Number of Experts: An initial bone mask was created by a "certified technologist." Then, an "independent dual-reader consensus review" was performed by two U.S. board-certified radiologists.
• Qualifications of Experts:
  • Certified Technologist (specific certification details not provided)
  • Two U.S. Board-Certified Radiologists (specific experience/years not provided, but "board-certified" implies a high level of qualification).

4. Adjudication method for the test set:

• Adjudication Method: A consensus review process was used. After an initial mask by a technologist, two U.S. board-certified radiologists independently evaluated the mask, recorded discrepancies, and iteratively reconciled them until consensus was achieved. This is a form of 2-reader independent reading with a consensus stage.

5. 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 was not performed as part of this submission's performance testing. The study focused on the standalone performance of the bone removal algorithm against a "definitive ground truth." The document does not describe human reader performance with or without the AI assistance.

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

• Yes, a standalone (algorithm only) performance study was conducted for the Bone Removal feature. The performance metrics (DSC and HD) directly measure the algorithm's output against the established ground truth.

7. The type of ground truth used:

• The ground truth used was expert consensus. Specifically, after an initial mask by a technologist, it was refined and finalized through an "independent dual-reader consensus review" by two U.S. board-certified radiologists.

8. The sample size for the training set:

• The provided document does not specify the sample size for the training set. It only describes the test set. It mentions the "Bone Removal is a tool that enhances the visibility of vessels... based on an AI algorithm cleared and marketed for Synapse 3D (K221677, reference device). It was improved for Synapse PACS 7.5.0." This implies the algorithm was already trained and validated prior to this submission, and this submission focuses on its performance after potential integration and improvements within Synapse PACS 7.5.0.

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

• The provided document does not describe how the ground truth for the training set (if applicable to this version's training) was established. Given that the algorithm was "improved" from a previously cleared device (Synapse 3D), the initial training and ground truth establishment would have occurred during the development and clearance process for that prior version.

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