(9 days)
The Coronis 3MP-21" is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
The MFGD 3621 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
Coronis 3MP-21" is a display system for medical viewing. It consists of 3 components: MFGD 3621 is a 21.3" grayscale LCD display. BarcoMed Coronis is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal Pro is user-friendly softcopy QA software. The display system can be a single-head system or multi-head system. In the last case it -ontains multiple displays and display controller boards.
MFGD 3621 is a 21.3" grayscale LCD display for medical viewing. It is combined with MediCal Pro, a user-friendly softcopy QA software.
The provided 510(k) summary for the Barco Coronis 3MP-21" and MFGD 3621 display systems does not contain explicit acceptance criteria or a study outlining the device's performance against such criteria.
This type of submission primarily focuses on establishing substantial equivalence to a predicate device. For display systems like these, the demonstration of substantial equivalence often relies on technical specifications and functional equivalence rather than clinical performance studies with specific metrics like accuracy, sensitivity, or specificity. The documents state that "Any difference between both devices does not affect safety or efficacy," implying that the technical characteristics are sufficiently similar to the predicate to not warrant new performance data.
Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission for a medical display system.
Here's an attempt to structure the answer based on the information available:
Acceptance Criteria and Study for Coronis 3MP-21" and MFGD 3621
The provided 510(k) summaries for the Barco Coronis 3MP-21" and MFGD 3621 do not include explicit acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) or a specific clinical study designed to test against such criteria. The regulatory pathway chosen for these devices is substantial equivalence to a predicate device, meaning the focus is on demonstrating that the new device is as safe and effective as a legally marketed product.
Instead of performance metrics, the acceptance criteria are implicitly defined by the technical and functional characteristics being substantially equivalent to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Coronis 3MP-21" | ||
| Technical Equivalence | The Coronis 3MP-21" system's components (display, controller, software) must perform functions comparable to its predicate device (Coronis 3MP Medical flat panel display system) and not introduce new safety or efficacy concerns. | - Display (MFGD 3621): 21.3" grayscale LCD, 2048 x 1536 pixels resolution. |
- Controller (BarcoMed Coronis): Fast, high-resolution, 10-bit in, 10-bit out LUT (1024 gray levels).
- Software (MediCal Pro): Automated image quality assurance, calibration.
- Comparison to Predicate: "Compared to the predicate device, the display of the Coronis 3MP-21" system has a different LCD panel with somewhat larger screen size. The other components of the system are the same."
- Conclusion: "Any difference between both devices does not affect safety or efficacy." |
| Functional Equivalence | The Coronis 3MP-21" system must serve the same general function as its predicate. | "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use." |
| Intended Use Equivalence | The intended use of the Coronis 3MP-21" must be the same as its predicate. | "The Coronis 3MP-21" is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography." (Identical to predicate's stated intended use characteristics). |
| MFGD 3621 Display | | |
| Technical Equivalence | The MFGD 3621 display must perform functions comparable to its predicate device (MFGD 2320 20-inch 2 Megapixel grayscale display) and not introduce new safety or efficacy concerns. | - Display (MFGD 3621): 21.3" grayscale LCD, 2048 x 1536 pixels resolution. - Software (MediCal Pro): Automated image quality assurance, calibration.
- Comparison to Predicate: "Compared to the predicate device, the MFGD 3621 display has a different LCD panel with larger screen size and higher resolution."
- Conclusion: "Any difference between both devices does not affect safety or efficacy." |
| Functional Equivalence | The MFGD 3621 display must serve the same general function as its predicate. | "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use." |
| Intended Use Equivalence | The intended use of the MFGD 3621 must be the same as its predicate. | "The MFGD 3621 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography." (Identical to predicate's stated intended use characteristics, though the predicate's intended use isn't explicitly listed in this document, it's inferred by the substantial equivalence claim). |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable / Not provided. No specific clinical test set or data provenance is mentioned as this is a technical substantial equivalence submission for a display system, not a diagnostic algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable / Not provided. Ground truth establishment by experts for a test set is not detailed in this type of submission for a display system.
4. Adjudication Method for the Test Set
- Not applicable / Not provided. Adjudication methods are typically for clinical performance studies, which are not described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not described. This type of study is more relevant for AI diagnostic algorithms where human reading performance is being measured and compared with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- No. A standalone performance study of an algorithm is not applicable, as these are medical display systems, not diagnostic algorithms. Their "performance" is primarily defined by their technical display capabilities and image quality, which is compared to predicate devices.
7. Type of Ground Truth Used
- Not applicable / Not provided directly. In the context of a display system, "ground truth" would relate to the display's ability to accurately render images according to industry standards, but this is assessed through technical specifications and comparison rather than a clinical ground truth like pathology or outcomes data. The "ground truth" for substantial equivalence is the predicate device's established safety and efficacy.
8. Sample Size for the Training Set
- Not applicable / Not provided. There is no mention of a training set as this is not an AI algorithm requiring one.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not provided. No training set is described.
In summary: The 510(k) submission for the Barco Coronis 3MP-21" and MFGD 3621 relies on demonstrating technical and functional equivalence to legally marketed predicate display devices. The acceptance criteria are implicit in aligning with the predicate's established performance, and formal clinical studies with specific performance metrics are not presented as part of this submission for a medical display system.
§ 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).