(41 days)
Quantor View is PACS image viewing software for DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). The software allows physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for viewing, researching, teaching, teleconferencing and online collaboration.
This is a PC software product used for viewing digital medical images having the following features: DICOM File Support (Read and display all DICOM files (mono-frame, multi-frame), Read and display non-DICOM file (JPEG Lossy, JPEG Lossless, JPEG2000, RLE), Read and write DICOM CD/DVD (DICOMDIR support), Export DICOM files to BMP, TIFF, JPEG, Convert Non-DICOM images to DICOM, Convert multi-frame image to AVI file), DICOM Network Support (DICOM Storage SCU/SCP, DICOM Query/Retrieve SCU/ SCP, DICOM Print SCU with 8, 12 bit support), Viewer Functions (Customizable toolbars, NN, linear, cubic, super sampling interpolation, ROIs: polygons, circles, rectangles and etc., Custom LUT and curve, CT/MR scout line view, Thumbnail images support, Support 1 to 4 monitors, User defined hanging protocol, tool bar, overlay, Local database support, Local backup support).
This document describes the QuantorView, a Picture Archiving and Communications System (PACS) software, seeking 510(k) clearance. The submission relies on demonstrating substantial equivalence to a predicate device, the eFilm Workstation (K012211). Therefore, the core of the "study that proves the device meets the acceptance criteria" is primarily focused on non-clinical performance testing to show that QuantorView functions comparably to the predicate and adheres to relevant standards.
Here's a breakdown of the requested information based on the provided text, recognizing that a 510(k) for a PACS viewing software typically does not involve clinical performance studies in the same way an AI diagnostic algorithm would.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for PACS viewing software, the "acceptance criteria" are primarily defined by the functional equivalence to the predicate device and compliance with relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance (QuantorView) |
|---|---|
| Functional Equivalence to Predicate Device (eFilm Workstation) | Declared Substantially Equivalent: "All technical and functional characteristics of the predicate and the QuantorView product are essentially the same, including the platform and DICOM image compatibility." |
| View Medical Images | PACS image viewing software for DICOM images (CR, DR, CT, MRI, Ultrasound, etc.), enabling viewing of digital medical images. |
| DICOM File Support | Reads and displays all DICOM files (mono-frame, multi-frame); reads and displays non-DICOM files (JPEG Lossy, JPEG Lossless, JPEG2000, RLE); reads and writes DICOM CD/DVD (DICOMDIR support); exports DICOM files to BMP, TIFF, JPEG; converts non-DICOM to DICOM; converts multi-frame to AVI. (Matches or exceeds predicate). |
| DICOM Network Support | DICOM Storage SCU/SCP, DICOM Query/Retrieve SCU/SCP, DICOM Print SCU with 8, 12 bit support. (Matches predicate). |
| Viewer Functions (Manipulation, Measurement) | Customizable toolbars, NN, linear, cubic, super sampling interpolation, ROIs (polygons, circles, rectangles, etc.), custom LUT and curve, CT/MR scout line view, thumbnail images, support for 1 to 4 monitors, user-defined hanging protocol, toolbar, overlay, local database support, local backup support. (Matches or exceeds predicate for image manipulation like rotate, flip, invert, and measurements like distance, angle, CTR). |
| Operating System Compatibility | Windows 7 or 8. (Comparable to predicate's Windows XP, Vista, Windows 7). |
| DICOM 3.0 Compliance | DICOM 3.0 Compliant. (Matches predicate). Tested and verified compliance with the DICOM 3 compliance statement. |
| Software Validation & Risk Analysis | Software validation and risk analysis done according to FDA Guidance document: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005". Testing verified compliance. Off-the-Shelf Software and Device Security issues addressed and documented. A Manufacturer Disclosure Statement for Medical Device Security (MDS) has been executed. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a quantitative "test set sample size" in terms of number of patient cases or images for clinical performance. As this is PACS viewing software, the testing would focus on the software's ability to correctly display and manipulate various types of DICOM images. This would likely involve a diverse set of DICOM files covering different modalities (CR, DR, CT, MRI, Ultrasound, etc.) and image characteristics to ensure proper handling and viewing functionalities. However, no specific number is provided.
- Data Provenance: Not explicitly stated as this is not a clinical study involving patient data from a specific region. The testing would involve generic DICOM files, potentially simulated or anonymized, to test the software's functionality and compliance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable or provided for this type of submission. Ground truth establishment with experts is typically for diagnostic AI algorithms where a clinical finding is being evaluated. For PACS viewing software, the "ground truth" is adherence to DICOM standards and accurate representation of image data.
4. Adjudication Method for the Test Set
- Not applicable or provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies with human readers to resolve discrepancies in diagnoses or interpretations. This is not a clinical study evaluating diagnostic performance.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing: Not applicable or required." MRMC studies are used to evaluate the impact of a device (often AI) on human reader performance, which is not the focus of a PACS viewing software 510(k).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone technical performance testing was done. The software itself was tested to ensure it met its functional specifications and complied with DICOM standards. This is evident from "Non-clinical performance testing. Software validation and risk analysis was done... Testing verified compliance with the DICOM 3 compliance statement has been executed." However, this is not a standalone diagnostic algorithm performance evaluation, but rather a standalone software functionality evaluation.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation is primarily technical compliance and adherence to established standards, specifically:
- DICOM 3.0 Compliance: Ensuring the software correctly interprets, displays, and handles DICOM files according to the standard.
- Functional Specifications: Verifying that all advertised features (image manipulation, measurement, network support, etc.) work as intended.
- Predicate Device Functionality: Demonstrating that QuantorView performs equivalently to the legally marketed eFilm Workstation.
8. The Sample Size for the Training Set
- Not applicable or provided. This device is PACS viewing software, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The software's capabilities are based on coded logic and adherence to standards, not on learning from a dataset.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).