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21.3-inch (54cm) Monochrome LCD Monitor ME213L (MDL2108A) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

Best suited for CT and MRI, ME213L (MDL2108A) is a 21.3-inch high definition monochrome medical imaging LCD monitor with higher luminance (1500cd/m²) and longer lifetime (three times as long as our existing models). With λ-Sentinel, a luminance stabilizing circuit, mounted, ME213L (MDL2108A) delivers stable display of images.

The provided text does not contain information regarding acceptance criteria for a device, nor does it describe a study that validates device performance against such criteria. The document is a 510(k) summary and an FDA clearance letter for a medical monitor (TOTOKU 21.3-inch (54cm) Monochrome LCD Monitor ME213L (MDL2108A)).

This type of document typically focuses on demonstrating substantial equivalence to a predicate device, rather than detailing specific performance studies with acceptance criteria in the manner you've outlined. It confirms the device's technical specifications and intended use, and states that it shares characteristics with a predicate device (MDL2004 (K021738)) with some improvements in display area, luminance, number of photo sensors, and lifetime.

Therefore, for your required information, the following answers are based on the absence of this information in the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not provided in the document.
• Reported Device Performance: The document states the device has "higher luminance (1500cd/m²)" and "longer lifetime (three times as long as our existing models)" compared to existing models, and includes a "λ-Sentinel, a luminance stabilizing circuit." However, these are descriptive features and not presented as performance "against" specific acceptance criteria in the context of a validation study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. This information is typically part of a performance study, which is not detailed here.

3. 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 / Not provided. This information is typically part of a performance study, which is not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. This information is typically part of a performance study, which is not detailed here.

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

• Not applicable. The device is a medical monitor, not an AI software/device for interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The device is a medical monitor, not an algorithm, so a standalone algorithm performance study is not relevant and was not conducted or mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable / Not provided. This information is typically part of a performance study, which is not detailed here.

8. The sample size for the training set

• Not applicable / Not provided. The device is a monitor, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

• Not applicable / Not provided. The device is a monitor, not a machine learning model, so there is no "training set" or associated ground truth.

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