(58 days)
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The Intuitive Workflow Tools are intended to be used as accessories for image enhancement in diagnostic displays.
The MDCC-6530 is a derivative of the MDCC-6230.
✓ Updated Liquid Crystal Display technology, providing a higher Contrast Ratio
✓ New housing, display stand and internal mechanics
✓ Change in electronics board, including integration of the power supply adaptor into the device
✓ Updated firmware
✓ New packaging
The MDCC-4430 only differs from MDCC-6530 in having a 4MP panel instead of a 6MP panel.
The Intuitive Workflow Tools package includes some software tools that are intended to support the intended use of the diagnostic displays by performing image enhancement.
The provided text is a 510(k) Summary for Barco NV's Coronis Fusion displays (MDCC-6530, MDCC-4430) and Intuitive Workflow Tools (IWT). The document focuses on demonstrating substantial equivalence to a predicate device (Coronis Fusion 6MP, MDCC-6230).
Based on the provided information, here's an analysis of the acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes specific modifications to the devices (Coronis Fusion MDCC-6530 and MDCC-4430) compared to the predicate, and how performance was assessed for these changes. The acceptance criteria essentially boil down to "PASS" for various tests, indicating that the new devices perform comparably or better than the predicate and meet established safety/performance standards.
| Modification to Device | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Update to LCD panel (higher Contrast Ratio, max output Luminance) | Bench Test Equivalence report | PASS (showed similar characteristics) | PASS |
| Change in housing and display stand | Environmental tests | PASS | PASS |
| Electrical Safety tests | PASS | PASS | |
| EMC tests | PASS | PASS | |
| Change in internal mechanics | Environmental tests | PASS | PASS |
| Electrical Safety tests | PASS | PASS | |
| EMC tests | PASS | PASS | |
| Change in electronics board | Environmental tests | PASS | PASS |
| Electrical Safety tests | PASS | PASS | |
| EMC tests | PASS | PASS | |
| Updated firmware | Firmware tests | PASS | PASS |
| Change in packaging | Environmental tests | PASS | PASS |
| Internal power supply instead of external power supply | Electrical Safety tests | PASS | PASS |
2. Sample Size for the Test Set and Data Provenance:
The document does not specify a sample size for any clinical test set. Instead, it relies on bench tests and technical comparisons to demonstrate substantial equivalence. The data provenance is implied to be from internal testing by Barco NV, related to the manufacturing and design of the devices. There is no information about country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The concept of "experts" to establish ground truth is not applicable in this submission as it's primarily a technical and performance comparison against a predicate device, not a clinical study requiring expert interpretation of medical images. The "ground truth" here is the performance and safety characteristics as defined by relevant industry standards and the predicate device's established performance.
4. Adjudication Method for the Test Set:
An adjudication method like 2+1 or 3+1 is not applicable as there was no clinical study involving human readers and interpretations that would require such a method for discrepancies.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not performed and is not mentioned in the document. The submission focuses on demonstrating substantial equivalence of the display hardware and software tools, not on evaluating the clinical effectiveness of AI assistance in improving human reader performance.
6. Standalone (Algorithm Only) Performance:
The document does not provide information about standalone (algorithm-only) performance. The "Intuitive Workflow Tools" are described as "accessories for image enhancement in diagnostic displays," implying they work with human-in-the-loop, but no specific performance metrics are given for the tools themselves in a standalone capacity. The main devices are displays, which inherently require a human for interpretation.
7. Type of Ground Truth Used:
The "ground truth" for the acceptance criteria and performance evaluation is based on:
- Technical specifications and performance characteristics of the predicate device (MDCC-6230).
- Compliance with relevant standards (implied by the "PASS" criteria for Electrical Safety, EMC, Environmental tests).
- Bench test results demonstrating that the new devices' characteristics are "similar" to the predicate and do not introduce new safety or performance issues.
There's no mention of expert consensus, pathology, or outcomes data being used as ground truth for this particular submission.
8. Sample Size for the Training Set:
The document does not mention a training set specific to the devices or the Intuitive Workflow Tools. Since this is a hardware and basic software accessory submission for image display/enhancement rather than a complex AI algorithm for diagnosis, the concept of a "training set" in the context of machine learning is not directly applicable or discussed here.
9. How the Ground Truth for the Training Set Was Established:
As no training set is discussed, the method for establishing its ground truth is not applicable/provided.
§ 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).