(168 days)
The Barco MWD 321 device is intended to be used in displaying and viewing digital images for and analysis review by trained medical practitioners.
The Barco MWD 321 Medical Workstation is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
The MWD 321 device is a workstation display.
The Barco MWD 321 is a monitor high resolution with electronic capabilities for evaluation of high resolution medical images.
This is a medical display workstation, which is a hardware device. The provided text doesn't contain a study that proves the device meets acceptance criteria in the way one would evaluate an AI/software medical device (e.g., diagnostic accuracy, sensitivity, specificity).
The "study" in this context refers to the substantial equivalence comparison made by FDA to legally marketed predicate devices. The acceptance criteria for such a device are primarily based on its technical specifications and performance characteristics being comparable to, and not raising new questions of safety or effectiveness compared to, predicate devices.
Here's the breakdown based on the information provided:
Acceptance Criteria and Device Performance
Since this is a hardware device (medical display workstation), the acceptance criteria are not typically presented as performance metrics like sensitivity/specificity for a diagnostic algorithm. Instead, they relate to technical specifications that ensure it functions as intended for displaying medical images for review and analysis. The "performance" being evaluated is its ability to perform the intended function comparably to predicate devices.
| Acceptance Criteria (Inferred from Substantial Equivalence and Device Description) | Reported Device Performance (Inferred from Substantial Equivalence and Device Description) |
|---|---|
| Intended Use: Displaying and viewing digital images for review and analysis by trained medical practitioners. | The Barco MWD 321 device is intended to be used in displaying and viewing digital images for and analysis review by trained medical practitioners. |
| Technological Characteristics: High resolution monitor with electronic capabilities for evaluation of high resolution medical images. | The Barco MWD 321 is a monitor high resolution with electronic capabilities for evaluation of high resolution medical images. |
| Safety and Effectiveness: Comparable to legally marketed predicate devices. | The device was found substantially equivalent to predicate devices, implying comparable safety and effectiveness for its intended use. |
Study Information (as applicable for a hardware device submission)
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Sample size used for the test set and the data provenance: Not applicable in the context of an AI/software diagnostic study. For a hardware device like a display, "testing" would involve engineering validation against specifications, not a diagnostic performance study on a test set of medical images in the same way as an AI algorithm. The FDA's substantial equivalence determination relies on comparing the device to existing predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as in diagnostic accuracy is not established for a display monitor.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. This is a display monitor, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a hardware device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a display workstation is its technical specifications and its ability to accurately render images, not a diagnostic ground truth for medical conditions.
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The sample size for the training set: Not applicable. Hardware devices are not "trained" with data in the same way AI algorithms are.
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How the ground truth for the training set was established: Not applicable.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.