Search Results

Vision Series PACS 4.3 is designed and marketed for soft copy reading, communication, printing and storage of studies produced by digital modalities, to include Digital Mammography.

Vision Series PACS receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.

Vision Series PACS imports images and render said images, upon request, within the AMICAS LightBeam Diagnostic Workstation utilizing both lossless (reversible) and lossy (irreversible) compression.

To support the diagnostic interpretation of Mammography studies, Vision Series PACS will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Vision Series PACS formats and delivers images over a network to a FDA-cleared DICOM printer as requested and defined by the user.

Vision Series PACS must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.

AMICAS Vision Series PACS 4.3 is software intended to create and display twodimensional and three-dimensional images of anatomy from a series of digitally acquired images.

Here's an analysis of the acceptance criteria and study information for K062477:

Noteworthy Observation: This 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device (Amicas Light Beam Diagnostic Workstation) based on technological characteristics and functional equivalence, rather than a typical performance study with quantitative acceptance criteria against a clinical ground truth. The "Testing" section describes a software verification process inherent to the product development, not a clinical validation study against a pre-defined performance metric.

1. Table of Acceptance Criteria and Reported Device Performance

• Software Only
• Image Measurements
• Multi-planar reformatting
• Volume Rendering
• Maximum Intensity Projection
• Image editing
• Printing
• DICOM Images (Lossless JPEG2000 & Lossy JPEG2000 Compression) | The device (Amicas Vision Series PACS 4.3) includes all specified features present in the predicate device. Additionally, it has new features not present in the predicate, such as "DICOM Overlay supporting MQSA-requirements" and "DICOM Printing." The table clearly shows "Yes" for all listed predicate features in the new device. |
  | Compliance with Software Requirements | The device is tested with reference to its Software Requirements Specifications. | The device undergoes functional testing as an integral part of Amicas's "VDEV" (Vision Development Elaboration Validation) product development process, with an independent verification of completeness of deliverables and testing reports by the Compliance Department. (No specific quantitative performance metrics are provided for this testing in the summary). |
  | Image Display Fidelity (Mammography Specific) | For diagnostic interpretation of Mammography studies:
• Display full fidelity DICOM image in a non-compressed format.
• Render images with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA.
• Display on monitors cleared by FDA for use in Digital Mammography (at least 5Mpixel resolution and other FDA-accepted technical specifications).
• Lossy compressed mammography images and digitized film screen images should not be used for primary diagnosis. | The device's "Indications For Use" explicitly state its design to meet these requirements. It specifies rendering full fidelity DICOM images in non-compressed format for mammography, displaying DICOM Overlay per MQSA, and requiring FDA-approved 5Mpixel+ monitors. It also states that lossy compressed mammography images should not be used for primary diagnosis. (The document asserts compliance via statement of intended use and features, rather than specific test results). |
  | DICOM Compatibility | Receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems. Formats and delivers images over a network to an FDA-cleared DICOM printer. | The "Indications For Use" state that it "receives images acquired from DICOM-compliant medical imaging systems" and "formats and delivers images over a network to a FDA-cleared DICOM printer." The technological characteristics also list "DICOM Images" (with compression types) and "DICOM Printing." |
  | User Responsibility/Safety | Users must ensure:
• Image quality, display quality, environmental lighting, and other factors are consistent with clinical application.
• Understanding of image manipulation tools to avoid obscuring anatomy.
• Access to patient data is limited to authorized, trained, and qualified individuals.
• Monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application. | The device includes cautionary statements in the user's guide and the 510(k) summary emphasizes the user's responsibility for these aspects, implying the device is safe when used appropriately under these conditions. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document refers to "Functional testing" and "Software Requirements Specifications" but does not detail the size or nature of the test dataset (e.g., number of images, cases).
• Data Provenance: Not specified. Given the nature of the submission (software functional equivalence), it's highly likely that testing involved synthetic data, internal test cases, or a limited set of de-identified clinical images, but no details are provided regarding origin or prospective/retrospective collection.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It's implied that "trained and qualified professionals" (radiologists, technologists, clinicians) would eventually use the system, but their involvement in establishing test set ground truth is not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified. Given the focus on functional software testing rather than clinical performance evaluation, a formal clinical adjudication method is unlikely to have been applied in the context of this submission.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable, as no such study was conducted or reported. This device is a PACS system designed for image display and management, not an AI-assisted diagnostic tool.

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

• Standalone Performance Study: Not applicable in the traditional sense of an AI algorithm. This device is a Picture Archiving Communication System (PACS), which is a display and management tool. Its "performance" is primarily defined by its functionality, compatibility, and compliance with imaging standards, rather than autonomous diagnostic accuracy. The testing described is against software requirements, not clinical ground truth for diagnostic accuracy.

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

• Type of Ground Truth: Not explicitly stated as clinical ground truth. The "Testing" section refers to verification against "Software Requirements Specifications." This implies that the ground truth for testing was the expected behavior and output as defined by the software's functional requirements documents, rather than a clinical gold standard (e.g., pathology, expert consensus on disease presence).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a PACS software, not an AI/ML model that undergoes a training phase.

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

• Ground Truth for Training Set Establishment: Not applicable, as this is not an AI/ML device requiring a training set.

Ask a specific question about this device