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The ME and CCL Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.

The ME and CCL Series Medical Displays are displays for medical use. ME Series are monochrome LCD displays consists of the following models. ME181L (Model No. MDL1809A), ME201L (Model No. MDL2006A), ME203L (Model No. MDL2004A). CCL Series are color LCD displays consists of the following models. CCL182 (Model No. CDL1808A), CCL202 (Model No. CDL2005A), CCL314 (Model No. CDL2103A).

This 510(k) summary for the Totoku Electric Co., Ltd. Flat Panel Displays, ME Series and CCL Series, primarily focuses on demonstrating substantial equivalence to a predicate device and compliance with regulatory standards. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way medical AI or diagnostic software devices typically would.

Here's a breakdown of why the requested information cannot be found in the provided text:

• Device Type: The device is a medical display, not an AI algorithm or a diagnostic software. Its performance is typically assessed by meeting technical specifications (e.g., resolution, luminance, color accuracy) and compliance with safety and EMC standards, rather than clinical performance metrics like sensitivity, specificity, or AUC.
• Regulatory Pathway: A 510(k) for a display device emphasizes "substantial equivalence" to a predicate device and compliance with established standards (like UL, CSA, IEC, FCC, VCCI, MDD/CE). This is different from the rigorous clinical efficacy studies often required for novel diagnostic devices.

Therefore, for your specific requests, based only on the provided text:

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

   • Acceptance Criteria (Implied): Compliance with various safety and EMC standards (UL2601-1, CSA No. 601-1, IEC60601-1 for medical safety; IEC60601-1-2, FCC-B/A, VCCI-B/A for EMC; UL1950, CSA No.950, LVD/CE(EN60950) for IT safety; EN55022, EN55024 for EMC). Substantial equivalence to the Totoku ME311L predicate device (K012099) in terms of principal characteristics (which are not detailed in this excerpt but referred to in Appendix 1).
   • Reported Device Performance: The document states, "All ME Series are complies with following standards," and "All CCL Series are complies with following standards." This implies the devices successfully met the requirements of these standards. No specific performance numbers (e.g., specific luminance readings, contrast ratios) are provided in this summary, but rather a statement of compliance.

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 or not provided. This information is typically for diagnostic algorithms tested on patient data, not for display hardware.

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 or not provided. Ground truth is not established for a display device in the clinical performance sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not provided.

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 device is a display, not an AI or diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a display device. The "ground truth" for a display would relate to its technical specifications and performance characteristics, which are verified against engineering standards and measurement tools, not clinical "ground truth."

8. The sample size for the training set: Not applicable. This is hardware; it does not involve training data.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) submission for a medical display device focuses on regulatory compliance and substantial equivalence rather than clinical performance metrics measured in studies with patient data and expert ground truth, which are typically associated with diagnostic software or AI algorithms.

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The ME Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.

The ME Series Medical Displays are displays for medical use. This product complies with Radiation performance standards (21 CFR Chapter J, Sub-chapter J).

Here's an analysis of the provided text regarding the Totoku Electric Co., Ltd. ME Series Medical Displays, focusing on acceptance criteria and study information.

It's important to note that this document is a 510(k) Summary, not a full study report. It primarily aims to demonstrate substantial equivalence to a predicate device. Therefore, it does not contain the level of detail typically found in a clinical study report or a comprehensive validation document for medical device performance.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ME Series Medical Displays are primarily demonstrated through a comparison with a predicate device, the BARCO MGD 221 2 MegaPixel Diagnostic Display (K000923), and compliance with various regulatory and safety standards. The document doesn't explicitly state quantitative "acceptance criteria" for clinical performance that would be measured in a study; instead, it matches specifications and intended use against a legally marketed device.

The table below summarizes the key performance characteristics reported for the ME Series models, particularly ME221f, and the predicate device. The underlying acceptance criteria for market clearance are implicitly that the ME Series devices meet or surpass the performance specifications of the predicate device and comply with relevant standards.

Table 1: Acceptance Criteria and Reported Device Performance (Key Characteristics)

Study Information

Based on the provided 510(k) Summary, the "study" conducted to prove the device meets acceptance criteria is a technical and performance comparison study against a predicate device, not a clinical trial involving human readers or a standalone algorithm performance study.

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

   • Test Set Sample Size: This type of information is not applicable to this document. The "test set" here refers to the specifications and performance characteristics of the ME Series devices themselves, compared against the published specifications of the predicate device. There is no dataset of medical images described.
   • Data Provenance: Not applicable in the context of a clinical or AI study. The data provenance refers to the technical specifications provided by the manufacturer of the ME Series and the predicate device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not applicable. There is no ground truth established by experts for a dataset in this submission. The "ground truth" for the comparison is the published, accepted specifications of the predicate device and the new device's manufacturing specifications.
   • Qualifications of Experts: Not applicable.

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

   • Adjudication Method: Not applicable. This summary focuses on technical specifications and regulatory compliance, not interpretation of clinical data requiring adjudication.

4. 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:

   • MRMC Study: No. This submission pertains to a medical display monitor, not an AI algorithm.
   • Effect Size: Not applicable.

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

   • Standalone Performance: No. This submission pertains to a medical display monitor, not an algorithm.

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

   • Type of Ground Truth: The "ground truth" in this context is the established technical and performance specifications of the predicate legally marketed device and the compliance with recognized industry and regulatory standards (e.g., UL, CSA, IEC, FCC, VCCI, DHHS, 21 CFR Chapter J). The submission asserts that the ME Series devices are substantially equivalent to the predicate based on these objective technical comparisons.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This is not an AI/machine learning device; there is no training set.

8. How the ground truth for the training set was established:

   • Ground Truth for Training Set: Not applicable.

In summary, the 510(k) filing for the Totoku Electric Co., Ltd. ME Series Medical Displays relies on demonstrating substantial equivalence to a predicate device by comparing technical specifications and showing compliance with relevant safety and performance standards. It is not a clinical study in the sense of evaluating a diagnostic algorithm's performance with patient data.

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