(32 days)
21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor MS23i2 (ML21023) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
MS23i2 (ML21023) is a 21.3-inch (54 cm) Monochrome LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface) and Display Port.
The provided text describes a 510(k) premarket notification for a medical display monitor and does not concern an AI/ML device or a device that undergoes a clinical study with acceptance criteria in the typical sense of diagnostic performance metrics like sensitivity or specificity.
Therefore, most of the requested information regarding acceptance criteria for device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies is not applicable to this submission.
The submission is for a 21.3 inch (54 cm) Monochrome LCD Monitor MS23i2 (ML21023) intended for displaying and viewing medical images for diagnosis. The nature of the device means its "performance" is primarily assessed through technical specifications and compliance with relevant standards rather than diagnostic accuracy.
Here's a breakdown of what can be extracted and why other parts are not applicable:
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A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional diagnostic sense. This device is a monitor. Its "performance" would be assessed against technical specifications (e.g., resolution, luminance, contrast, uniformity, grayscale reproduction) and compliance with industry standards (e.g., DICOM Part 14 for grayscale display function, IEC 60601-1 for electrical safety). The document does not provide a table with these technical acceptance criteria or reported performance values. It only states the display resolution (1200 x 1600 / 1600 x 1200) and that it is a monochrome 2M pixel LCD monitor.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. As this is a display monitor, there is no "test set" of medical images in the context of evaluating a diagnostic algorithm's performance. The evaluation would be based on the physical characteristics and software functionality of the monitor itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth establishment related to diagnostic accuracy is relevant for a medical 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 hardware device (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. There is no algorithm in this product that would be evaluated in a standalone capacity.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable.
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The sample size for the training set
- Not Applicable. There is no algorithm to train.
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How the ground truth for the training set was established
- Not Applicable.
Summary based on available information:
The K113443 submission for the TOTOKU MS23i2 (ML21023) monitor is a 510(k) premarket notification for a medical display device. The "study" proving it meets acceptance criteria typically involves demonstrating that the device's technical specifications and performance meet established standards for medical monitors and are substantially equivalent to a predicate device.
- Intended Use: To be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
- Predicate Device: 21.3 inch (54 cm) Monochrome LCD Monitor MS21i2 (MDL2127A) (K081945).
- Substantial Equivalence: The applicant states that the MS23i2 (ML21023) shares the same characteristics with its predicate device MS21i2 (K081945) except for the main board and power supply. This means the primary "study" involved comparing the technical specifications and, presumably, testing the performance aspects (like luminance, contrast, resolution, DICOM conformance) of the new device against the predicate and relevant standards.
Without further information from the full 510(k) submission, specific technical acceptance criteria and their measured values for items like luminance, uniformity, or DICOM conformance cannot be provided. However, the nature of the device means these are the types of criteria that would be assessed.
§ 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).