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

Device Description

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

AI/ML Overview

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)

Item	Acceptance Criteria (Implied by Predicate Device MGD221)	Reported Device Performance (ME221f)	Notes on Acceptance
510(k) Number	K000923	Not known (for initial submission)	For the predicate. ME Series receives K012099.
Display Area	300mm x 400mm	Horizontal 300mm, vertical 400mm	Equivalent.
Luminescent Material	B4-L8	P45 (standard) or P4 (optional)	Different materials, but both are types used in monochrome CRTs. Implied to be acceptable based on overall performance.
Input Signal	Video input connector type: BNC & 0.7 Vpp; Sync inputs: CS or HS and VS (BNC), 0.5Vpp Synchro input; Termination: 75Ω	Video signal - analog 0.714Vp-p/75Ω; Synchronizing signal - 1.0-5.5Vp-p/3.9kΩ; Synchro input - Separate/composite/composite video; Connector - BNC and SD-sub 15p	Functionally equivalent to handle video input, despite minor specification differences.
Maximum Display Pixels	1280 dots x 1600 line	1200 dots x 1600 line	Closely comparable, 1200x1600 is a common diagnostic resolution. The other ME models vary (e.g., ME521f is 2048 x 2560).
Scanning Frequency	Horizontal 80-140kHz, Vertical 48-150Hz	Horizontal 30k-127kHz, vertical 50-180Hz	Broadly comparable ranges for display refresh.
Maximum Image Clock	250MHz	250MHz	Equivalent.
Maximum Luminance	Calibrated: 222cd/m²; Peak: 360cd/m²	410 cd/m² min. (P4 luminescent material) for both partial white (20%) and total white (100%)	ME Series meets or exceeds the predicate's peak luminance. (Other ME models vary, e.g., ME223f is 800 cd/m² min.)
Luminance Calibration	Frontal X-Rite DTP92	Software (standard item) Photosensor (optional item) – DTP92 (X-Lite)	Similar calibration methods, ME Series offers the same optional photosensor.
Serial Communication Connector	1 input, 1 output; 9600 baud, RS232; SUB-D9 male/female connector	D-sub 9p x 2	Equivalent functionality.
Agency Standards	Medical safety: UL2601-1, cUL2601-1, IEC 60601-1, CE (EN60601-1); Others: DHHS	Medical safety: UL2601-1, CSA No.601-1, IEC 60601-1, MDD/CE (EN60601-1); Others: DHHS	Both devices comply with relevant medical safety and radiation standards. This is a critical "acceptance criterion."
Dimensions & Weight	Unpacked, 400 x 561 x 558 mm, 37.4kg; Packed, 630 x 780 x 788 mm, 55.9 kg	Net, 412 x 578 x 518 mm (W x H x D) 35kg; Packed, 560 x 710 x 730 mm (W x H x D) 41kg	Similar, within expected variation for physically comparable devices.
Power Supply	100-240V AC, 50/60Hz	100-240V AC, 50/60Hz	Equivalent.

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.

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.
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.
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.
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.
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.
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.
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.
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.

Summary

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K0/2099

JUL 3 1 2001

510(k) Summary as required by 807.92

1. Company Identification

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

2. Official Correspondent

Mikio Hasegawa (Mr.) Manager Design Group

3. Date of Submission

June 7, 2001

4. Device Trade name

Monochrome perfectly flat panel displays, ME Series

5. Common Name

Monitor, display, workstation, and others

6. Classification

Medical displays were classified in Class II per 21 CFR 890.2050.

7. Predicate Device

BARCO MGD 221 2 MegaPixel Diagnostic Display, manufactured by BARCO NV / Display Systems (K000923). Comparison of the principal characteristics of the three devices which are pertinent to clinical performance is shown in Appendix 1.

8. Description of Device

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

9. Intended Use

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

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Explanation of ME Series

ME Series consists of the following models.

ME221f (Model No. MDT 2205A) ME222f (Model No. MDT 2210A) ME223f (Model No. MDT 2212A) ME224f (Model No. MDT 2210A) ME521f (Model No. MDT 2209A) ME311L (Model No. MDL 2102A)

Comparison of specifications is shown in Appendix 2.

Compliance standards

Medical safety: UL2601-1, CSA No.601-1, IEC60601-1, MDD/CE (EN60601-1)

EMC: MDD/CE (EN60601-1-2), FCC-A, VCCI-A, IEC60601-2

Others: DHHS

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The state of the state of the states of the states

Item	ME221f/4	MGD221		ME221f	ME222f	ME223f*1	ME224f*2	ME521f	NOTE
510(k) Number	Not known	K000923	Item
Display area	Horizontal 300mm, vertical 400mm	300mm x 400mm	10(k) Number	Not known	Not known	Not known	Not known	Not known	*1 ME223f is identical to ME221f except for CRT focus.
Luminescent material	P45 (standard) or P4 (optional)	B4-L8	Display area	Horizontal 300mm, vertical 400mm	Horizontal 400mm, vertical 300mm	Horizontal 300mm, vertical 400mm	Horizontal 400mm, vertical 300mm	Horizontal 302mm, vertical 378mm
Input signal	Video signal - analog 0.714Vp-p/75 $\Omega$Synchronizing signal - 1.0-5.5Vp-p/3.9k $\Omega$Synchro input - Separate/composite/composite video.Connector - BNC and SD-sub 15p (VGAconnection, Gch for video)	• Signal inputsVideo input connector type: BNCVideo input voltage: 0.7 VppTermination: 75 $\Omega$• Synchronization inputsInputs provided: CS or HS and VSInput connector type: BNCTermination: 75 $\Omega$Sync input voltage: nominal 0.5Vpp	Luminescent material	P45 (standard) or P4 (optional)	P45 (standard) or P4 (optional)	P45 (standard) or P4 (optional)	P45 (standard) or P4 (optional)	P45 (standard) or P4 (optional)
Maximum display pixels	1200 dots x 1600 line	1280 dots x 1600 line	Input signal	Video signal - analog 0.714Vp-p/75ΩSynchronizing signal - 1.0-5.5Vp-p/3.9kΩSynchro input - Separate/composite/composite video.Connector - BNC and SD-sub 15p (VGA connection, Gch for video)	Video signal - analog 0.714Vp-p/75ΩSynchronizing signal - 1.0-5.5Vp-p/3.9kΩSynchro input - Separate/composite/composite video.Connector - BNC and SD-sub 15p (VGA connection, Gch for video)	Video signal - analog 0.714Vp-p/75ΩSynchronizing signal - 1.0-5.5Vp-p/3.9kΩSynchro input - Separate/composite/composite video.Connector - BNC and SD-sub 15p (VGA connection, Gch for video)	Video signal - analog 0.714Vp-p/75ΩSynchronizing signal - 1.0-5.5Vp-p/3.9kΩSynchro input - Separate/composite/composite video.Connector - BNC and SD-sub 15p (VGA connection, Gch for video)	Video signal - analog 0.714Vp-p/50Ω or 75Ω (optional)Synchronizing signal - TTL level, negativeSynchro input - Separate.Connector- BNC	*2 ME224f is identical to ME223f except for luminance.
Scanning frequency	Horizontal 30k-127kHz, vertical 50-180Hz	Horizontal 80-140kHz, Vertical 48-150Hz	Maximum display pixels	1200 dots x 1600 line	1600 dots x 1200 line	1200 dots x 1600 line	1600 dots x 1200 line	2048 dots x 2560 line
Maximum image clock	250MHz	250MHz	Scanning frequency	Horizontal 30k-127kHz, vertical 50-180Hz	Horizontal 30k-110kHz, vertical 50-180Hz	Horizontal 30k-127kHz, vertical 50-180Hz	Horizontal 30k-110kHz, vertical 50-180Hz	Horizontal 186kHz, vertical 71Hz (fixed)
Maximum luminance	410 cd/m2 min. (P4 luminescent material)for both partial white (20%) and total white(100%)	Calibrated: 222cd/m2; 65fLPeak: 360cd/m2; 105fL	Maximum image clock	250MHz	250MHz	250MHz	250MHz	500MHz
Luminance calibration	Software (standard item)Photosensor (optional item) – DTP92(X-Lite)	Frontal X-Rite DTP92	Maximum luminance	410 cd/m² min. (P4 luminescent material) for both partial white (20%) and total white (100%)	600 cd/m² min. (P45 luminescent material) for both partial white (20%) and total white (100%)	800 cd/m² min. (P4 luminescent material) for both partial white (20%) and total white (100%)	600 cd/m² min. (P45 luminescent material) for both partial white (20%) and total white (100%)	600 cd/m² min. (P45 luminescent material) for both partial white (20%) and total white (100%)
Serial communication connector	D-sub 9p x 2	1 input, 1output9600 baud, RS232SUB-D9 male/female connectorOperational at save state	Luminance calibration	Software (standard item)	Software (standard item)	Software (standard item)	Software (standard item)	Software (standard item)
Agency standards	Medical safety: UL2601-1, CSA No.601-1,IEC 60601-1, MDD/CE (EN60601-1)Others: DHHS	Medical safety: UL2601-1, cUL2601-1,IEC 60601-1, CE (EN60601-1)Others: DHHS		Photosensor (optional item) - DTP92 (X-Lite)	Photosensor (optional item) - DTP92 (X-Lite)	Photosensor (optional item) - DTP92 (X-Lite)	Photosensor (optional item) - DTP92 (X-Lite)	Photosensor (optional item) - DTP92 (X-Lite)
Dimensions and weight(incl. tilt and swivel)	Net, 412 x 578 x 518 mm (W x H x D) 35kgPacked, 560 x 710 x 730 mm (W x H x D)41kg	Unpacked, 400 x 561 x 558 mm, 37.4kgPacked, 630 x 780 x 788 mm, 55.9 kg	Serial communication connector	D-sub 9p x 2	D-sub 9p x 2	D-sub 9p x 2	D-sub 9p x 2	D-sub 9p x 2
Power supply	100-240V AC, 50/60Hz	100-240V AC, 50/60Hz	Agency standards	Medical safety: UL2601-1, CSA No.601-1, IEC 60601-1, MDD/CE (EN60601-1)Others: DHHS	Medical safety: UL2601-1, CSA No.601-1, IEC 60601-1, MDD/CE (EN60601-1)Others: DHHS	Medical safety: UL2601-1, CSA No.601-1, IEC 60601-1, MDD/CE (EN60601-1)Others: DHHS	Medical safety: UL2601-1, CSA No.601-1, IEC 60601-1, MDD/CE (EN60601-1)Others: DHHS	Medical safety: UL2601-1, CSA No.601-1, IEC 60601-1, MDD/CE (EN60601-1)Others: DHHS
Dimensions and weight (incl. tilt and swivel)	Net, 412 x 578 x 518 mm (W x H x D) 35kgPacked, 560 x 710 x 730 mm (W x H x D) 41kg	Net, 505 x 500 x 515 mm (W x H x D) 35kgPacked, 615 x 655 x 650 mm (W x H x D) 40kg	Net, 412 x 578 x 518 mm (W x H x D) 35kgPacked, 560 x 710 x 730 mm (W x H x D) 41kg	Net, 505 x 500 x 515 mm (W x H x D) 35kgPacked, 615 x 655 x 650 mm (W x H x D) 40kg	Net, 412 x 578 x 552 mm (W x H x D) 35kgPacked, 560 x 710 x 730 mm (W x H x D) 41kg
Power supply	100-240V AC, 50/60Hz	100-240V AC, 50/60Hz	100-240V AC, 50/60Hz	100-240V AC, 50/60Hz	100-240V AC, 50/60Hz

100 100

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Appendix 2 Comparison table among application model

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Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2001

Totoku Electric Co., Ltd. % Mr. Shinichi Yamanaka Safety Dept. Cosmos Corporation 319 Akeno, Obata-cho, Watarai-gun Mie-ken, 519-05 JAPAN

Re: K012099 ME Series Medical Display Dated: June 7, 2001 Received: July 5, 2001 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Yamanaka:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the w inave is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices device is substantally cquiraline (tor the materials of the Medical Device Amendments, or to devices matkled in meetstance commerce provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of 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 (Premarket Approval), it may be subject 11 your device is classince (Sc above) and etaxe to entry vour device can be found in the Code of Federal Regulations, to such and conceller. A substantially equivalent determination assumes compliance with the Current Good Manufacturing I I uc 21, 1 at 3 ove to 099. 11 our of the System Regulation (QS) for Medical Devices: General regulation (21 CFR Part Placitie requirements, as set tour in the Quality Dysterial regultures Administration (FDA) will verify such assumptions. Failure o comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to comply with the Federal Register. Please note: this response to your premarket notification submission does not concenting your device in the Poccal Regions 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding I his when while he of your device to a legally marketed predicate device results in a classification for your device and 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 and additionally 809.10 for in vitro 11 you deste spothe arrice to your corress of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your common "Misolanding of Ferences to premation in the Division of Small Manufacturers Assistance at its toll-free number (800) 1638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours

Nancy C. bogdon

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

Enclosure (s)

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KO12099 510(k) Number (If known): Not known

Device Name: Monochrome perfectly flat panel display, ME Series

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use

OR Over-The-Counter Use

(Optional Format 1-2-96)

Nancy Broghon

(Division Sign-Off)

Division of Reproductive. Abdominal.

and Radiologi 510(k) Numbe

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).