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The Coronis 3MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

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The provided document is a 510(k) clearance letter from the FDA for the "Coronis 3MP (MDCG-3221)" device, which is a medical flat panel display system. This document grants market clearance based on substantial equivalence to predicate devices and does not contain the detailed study information regarding acceptance criteria and performance of the device itself.

Therefore, I cannot provide the requested information based on this document. This document primarily focuses on regulatory approval, not on the technical performance study of the device.

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The Coronis 3MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be need in primary image diagnosis in mammography.

Coronis 3MP is a display system for medical viewing. It consists of 3 components: MDCG 3120-CB is a 20.8" grayscale LCD display. MXRT 5100 is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb Agent for a softcopy QA software application for local calibration and QA control.
The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.

The provided text describes a 510(k) submission for the Barco Coronis 3MP display system. This document focuses on establishing substantial equivalence to a predicate device (Coronis 2MP-21") rather than demonstrating performance against specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided text. The submission is a regulatory filing for a medical device display, emphasizing its technical characteristics and intended use, and declaring it "substantially equivalent" to an existing device, which is a different type of assessment than proving efficacy or performance against clinical metrics.

The "conclusion" section explicitly states: "The 510(k) Pre-Market Notification for the Barco Coronis 3MP contains adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device." This indicates the nature of the submission.

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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

• 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.

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The Barco Coronis 3MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The Coronis 3MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

The Coronis 3MP device is a digital image display system
The Barco Coronis 3MP device consists of components to provide high resolution visualization of digital images.

The provided text does not contain detailed information about specific acceptance criteria and the study that proves the device meets these criteria. The document is a 510(k) summary for the Barco Coronis 3MP Medical Flat Panel Display System, a device intended for displaying and viewing digital medical images. It primarily focuses on demonstrating substantial equivalence to a predicate device (Barco NV Display Systems MeDis 5MP2 Dual-Head Medical Diagnostic Display System, K001753).

The text does not provide the following information:

1. A table of acceptance criteria and the reported device performance: This level of detail about technical performance metrics and their comparison is absent.
2. Sample size used for the test set and the data provenance: There is no mention of a test set, data provenance, or any clinical or technical study outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set is discussed, this information is not present.
4. Adjudication method for the test set: No test set is described, so no adjudication method is mentioned.
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: This device is a display system, not an AI or diagnostic algorithm, so an MRMC study with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a display system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is discussed as there is no diagnostic algorithm or study evaluated.
8. The sample size for the training set: No training set is applicable or mentioned for a display system.
9. How the ground truth for the training set was established: Not applicable.

The document mainly states the device's intended use, classification, and asserts substantial equivalence to a predicate device based on its technological characteristics (high-resolution visualization of digital images). Device performance is implied to be similar to the predicate device, which would have undergone its own clearance process, but specific performance metrics for the Coronis 3MP are not detailed in this summary.

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