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.

Summary

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APR 2 3 2004

510(k) Summary

as required by 807.92

Ko3/661

Company Identification 1.

Totoku Electric Co., Ltd. 300 Oya, Ueda-shi, Nagano-ken, 386-0192, JAPAN 011-81-268-34-5484 Tel: Fax: 011-82-268-34-5565

Official Correspondent 2.

Mikio Hasegawa (Mr.) General Manager Product Development Dept.

Date of Submission 3.

May 26, 2003

Device Trade Name 4.

5M Medical Flat Panel Display, ME511L

Common Name 5.

Monitor, display, workstation, and others

6. Classification

Classification
Medical display is classified as Class I or II per 21 CFR 899 2050

Predicate Device 7.

Totoku ME315L, 3 Megapixel Diagnostic Display, manufactured by Totoku Electric Co., Ltd. (K030274). Comparison of the principle characteristics of the device, which is pertinent to clinical performance, is shown in Appendix 1.

Description of Device 8.

ME511L is medical use display.

9. Intended Use

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

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10. Explanation of ME511L

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

The specifications are shown in Appendix 2.

11. Compliance

ME511L complies with the following standards.

Medical Safety: UL2601-1, CSA No. 601-1, MDD/CE (EN60601-1),

and TUV-GM

MDD/CE (EN60601-1-2), FCC-A EMC:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle's body is composed of three vertical lines, and its legs are represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2004

Mr. Mikio Hasegawa General Manager TOTOKU ELECTRIC CO., LTD, MM Company, Design Group 300 Oya, Ueda, Nagano 386-1092 JAPAN

Re: K031661 Trade/Device Name: 5M Medical Flat Panel Display, ME511L Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: February 3, 2004 Received: February 5, 2004

Dear Mr. Hasegawa:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stared in the enot 28, 1976, the enactment date of the Medical Device Amendments, or to econiner of the they are reclassified in accordance with the provisions of the Federal Food, Drug, de noos that hat ( Act ( Act ( that do not require approval of a premarket approval application ( PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, the cerony in the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial cquivalence determination does not mean I loase ve activities made a determination that your device complies with other requirements of the Act that 1 DA has made a very regulations administered by other Federal agencies. You must comply or any I bactar starss and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your artist equivalence of your device to a legally premarket notification. The PDA intellig of substantial equivalians of thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the regulation and 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - reg contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotive and any and on the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, please note their - Other gene Office of Compliatice at (301) 574-4057. This, production of the Peneral by reference to premarket nomication (210) it it all one of on the Division of Small
information on your responsibilities under the Act may be of the sumber (800) 638-2041 information on your responsibilities under the Assistance at its toll-dreamenting html Manufacturers, International and Collisation Postedwith Art Collection of School

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Not known 510(k) Number (If known):

K63/661

5M Medical Flat Panel Display, ME511L Devicc Name:

Indications for Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation

Prescription Use

OR Over-The-Counter Use

David A. Lynam

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Regulation Number and Section

§ 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).