(207 days)
The MFGD 1318 18 Inch 1 Megapixel Grayscale LCD Display 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.
The MFGD 1318 is a diagnostic display. The MFGD 1318 device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.
This 510(k) premarket notification (K033005) is for a medical display device, not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML software performance (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable.
The submission focuses on establishing substantial equivalence to a predicate device (Coronis 1MP Medical Flat Panel Display System, K023340) based on technological characteristics and intended use. The "acceptance criteria" here refer to the performance specifications of the display hardware, and "study" refers to tests and comparisons demonstrating these specifications are met and are equivalent to the predicate.
Here's the information that can be extracted, and where the requested AI/ML specific information is not applicable (N/A):
- Table of acceptance criteria and the reported device performance
| Criteria | MFGD 1318 Performance | Basis for Acceptance |
|---|---|---|
| Intended Use | Displaying and viewing digital images (excluding digital mammography) for review by trained medical practitioners. | Substantially equivalent to predicate device (K023340) which has the same intended use for medical practitioners. |
| Technological Characteristics | High resolution monitor with electronic capabilities for evaluation of high resolution medical images. | Substantially equivalent to predicate device (K023340) as both are 1 Megapixel Grayscale LCD Displays for medical imaging. Specific technical display parameters (resolution, brightness, contrast, etc.) would have been detailed in the full 510(k) submission, but are not provided in this summary. |
| Display Type | 18 Inch 1 Megapixel Grayscale LCD Display | Matches the display type and resolution category of the predicate device. |
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Sample size used for the test set and the data provenance
- Sample size for test set: N/A (as this is a hardware device, not an AI/ML algorithm evaluated on a dataset of medical images).
- Data provenance: N/A
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A (no ground truth established in the context of an AI/ML algorithm's performance on medical images).
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Adjudication method for the test set
- N/A
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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
- N/A (This is not an AI-assisted device). The evaluation here is about the technical performance of a display, not its impact on human reader performance with AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A (This is a display device, not a standalone algorithm).
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The type of ground truth used
- N/A. The "ground truth" for a display device would relate to its physical characteristics meeting industry standards and safety regulations, not a medical diagnosis dataset.
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The sample size for the training set
- N/A.
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How the ground truth for the training set was established
- N/A.
§ 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).