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ME511L Medical Display is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.

ME511L is medical use display. ME 511L is monochrome LCD display. ME511L (Model No. MDL2105A)

The provided text is a 510(k) Summary for a medical display device (ME511L). It focuses on the device's identification, classification, intended use, and compliance with standards. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical effectiveness studies in the way you've requested for an AI/CAD product.

This document is for a medical display device (monitor), not an AI or computer-aided diagnosis (CAD) product. Therefore, the types of studies and acceptance criteria you've asked for (e.g., performance metrics like sensitivity/specificity, MRMC studies, ground truth establishment by experts, training set sample size) are not applicable to this product as typically described in a 510(k) for a display.

The "acceptance criteria" for a medical display would typically revolve around technical specifications such as resolution, luminance, contrast ratio, uniformity, viewing angle, and compliance with medical display standards (like DICOM Part 14 for grayscale displays). The "study" proving these would be engineering tests and measurements against these technical specifications, not clinical trials with human readers or AI algorithms.

Here's a breakdown of what can be extracted or inferred based on the document's nature, and what cannot:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in the way you'd expect for an AI/CAD. The acceptance criteria for a display are inherent in its technical specifications and compliance with standards.
  • Inferred Criteria:
    • Resolution: 5 Megapixel (5M)
    • Display Type: Flat Panel (LCD), monochrome
    • Compliance with Medical Safety Standards: UL2601-1, CSA No. 601-1, MDD/CE (EN60601-1), TUV-GM
    • Compliance with EMC Standards: MDD/CE (EN60601-1-2), FCC-A
• Reported Device Performance: The document only states that "The specifications are shown in Appendix 2." (which is not provided in the input text). It also states "ME511L complies with the following standards." Therefore, the "performance" is implicitly meeting these standards and specifications.

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

• Not Applicable. This device is a display monitor, not an algorithm that processes data or requires a test set of medical images.

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. This device is a display monitor. Ground truth for image interpretation is irrelevant to the display hardware itself.

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

• Not Applicable.

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. This is a hardware device (display), not an AI system. MRMC studies compare human performance with and without AI assistance; this device provides neither.

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

• Not Applicable. This is a display device, not an algorithm.

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

• Not Applicable.

8. The sample size for the training set

• Not Applicable. This device is a display monitor, not an AI model.

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

• Not Applicable.

Summary of what the document DOES provide:

• Device Name: 5M Medical Flat Panel Display, ME511L
• Intended Use: For use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.
• Predicate Device: Totoku ME315L, 3 Megapixel Diagnostic Display (K030274). This indicates that the 5M device is an upgrade in resolution from a 3M device, which would be the primary characteristic for substantial equivalence.
• Classification: Class I or II per 21 CFR 899.2050 (The FDA letter later classifies it as Class II, product code 90 LLZ, regulation 21 CFR 892.2050 - Picture archiving and communication system).
• Compliance with Standards: UL2601-1, CSA No. 601-1, MDD/CE (EN60601-1), TUV-GM (Medical Safety) and MDD/CE (EN60601-1-2), FCC-A (EMC). This is the key "evidence" of meeting criteria for a display.

In conclusion, the input text describes a medical display, and therefore the framework you've provided for evaluating an AI/CAD device's performance does not align with the information contained in this document.

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