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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.

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.

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