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20.1-inch (51cm) Color LCD Monitor CDL2010A (CCL204) is 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.

CDL2010A has a multi-displaying function corresponding to the resolution from VGA 640 x 480 to UXGA 1600 x 1200. This is also compliant with VESA standard display mode.

The provided 510(k) summary for the TOTOKU ELECTRIC CO., LTD. 20.1-inch (51cm) Color LCD Monitor CDL2010A (CCL204) is for a medical display device, not a diagnostic AI algorithm. Therefore, the questions regarding acceptance criteria and performance against a test set, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.

Medical display devices are typically evaluated based on technical specifications related to image quality (e.g., resolution, luminance, contrast, uniformity, color accuracy) and compliance with relevant industry standards (e.g., DICOM Part 14 for grayscale display function, display calibration standards). The "acceptance criteria" for such a device would generally involve meeting these technical specifications and demonstrating substantial equivalence to a predicate device in terms of intended use and technological characteristics.

The "study that proves the device meets the acceptance criteria" for a medical display would involve a series of technical tests and measurements to verify that the display performs according to its specifications and regulatory requirements.

However, based on the provided document, here's what information can be extracted or reasonably inferred:

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

The document does not provide a specific table of acceptance criteria with corresponding performance data in the format typically seen for algorithms. Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicate device, CDL2009A (K061061), and meeting the general requirements for a Class II Picture Archiving and Communication System (PACS) component.

• Acceptance Criteria (Inferred from Substantial Equivalence and Device Description):

  • Intended Use: "displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography." (Must match predicate and be appropriate for a medical display).
  • Technological Characteristics: Multi-displaying function corresponding to resolutions from VGA 640 x 480 to UXGA 1600 x 1200, VESA standard display mode compliant. (Needs to be similar to predicate, or differences do not raise new questions of safety or effectiveness).
  • Image Quality Parameters: (Not explicitly stated in the summary, but for a monitor, this would include luminance, contrast ratio, uniformity, resolution, color accuracy, and compliance with DICOM Part 14 for grayscale display, all of which would need to be tested and meet established standards for medical displays).
  • Safety and EMC: (Compliance with relevant electrical safety and electromagnetic compatibility standards).

• Reported Device Performance (Implicit/Stated):

  • Intended Use: The device "is 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," which is accepted by the FDA.
  • Technological Characteristics: "CDL2010A has a multi-displaying function corresponding to the resolution from VGA 640 x 480 to UXGA 1600 x 1200. This is also compliant with VESA standard display mode."
  • Substantial Equivalence: The FDA's 510(k) clearance letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, implying that any differences in performance from the predicate (CDL2009A) do not raise new concerns about safety or effectiveness. The key difference noted is "except for the LCD panel."

For the remaining points (2-9), these are entirely non-applicable to the provided document as it concerns a hardware display device, not a diagnostic algorithm that processes images and provides an output for interpretation.

• 2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" of medical images in the context of evaluating a display device.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth from experts is not established for hardware display evaluation in this manner.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are for evaluating diagnostic performance with and without AI assistance for human readers, which is irrelevant for a display device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable. This is not a trained AI model.
• 9. How the ground truth for the training set was established: Not applicable.

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