(39 days)
JUSHA-C33C LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
JUSHA-C33C LCD Monitor is the display system with the high resolution (2048*1536), high luminance (600 cd/m²), and10 bit display colors expanded to 12 bit color expansion technology, 8 DICOM look up table and 3 GAMMA look up table inside. In particular, JUSHA-C33C LCD Monitor contains CGA function, it is specially made by JUSHA, it can automatic identify gray and color signals, then gray area calls DICOM LUT and color area calls GAMMA2.2 LUT. JUSHA-C33C has ambient brightness adapting and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results. The product is consisted of the following components: - 21.3" Color TFT LCD Panel - JUSHA-C33/45T motherboard/FR-4/REV:0.9 - JUSHA-C33C LCD Monitor software - Power Adapter - Data Cable. The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 1988+A1 : 1991 + A2:1995 IEC 60601-1-2 Edition 3:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
This section describes the acceptance criteria and the study conducted to demonstrate that the JUSHA-C33C LCD Monitor meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the JUSHA-C33C LCD Monitor primarily focuses on demonstrating substantial equivalence to a predicate device (EIZO RX340) through non-clinical performance characteristics and compliance with recognized standards. Therefore, the "acceptance criteria" are implicitly defined by the predicate device's specifications and the safety and electrical standards. The study presented a direct comparison of key technical specifications.
| Attribute | Predicate Device (EIZO RX340 - K113562) Acceptance Criteria | Proposed Device (JUSHA-C33C LCD Monitor) Performance | Differences/Compliance |
|---|---|---|---|
| General | |||
| Product | EIZO RX340 | JUSHA-C33C LCD Monitor | N/A (Product Name) |
| 510(k) Number | K113562 | K141684 | N/A (Approval Number) |
| Display Characteristics | |||
| Screen Technology | 21.2" Color TFT LCD Panel | 21.3" Color TFT LCD Panel | Minor size difference |
| Viewing Angle (H, V) | Horizontal 170°, Vertical 170° | Horizontal 176°, Vertical 176° | Proposed device is better |
| Resolution | 2048 x 1536 / 1536 x 2048 | 2048 x 1536 / 1536 x 2048 | Identical |
| Display Area | 323.7 (H) x 431.6 (V) mm | 324.864 (H) x 433.152 (V) mm | Very similar |
| Contrast Ratio | 1400:1 | 1400:1 | Identical |
| Scanning Freq. (H; V) | 31 | 96.7kHz; 60Hz | Within typical ranges, presumed compatible |
| Recommended Luminance | 400cd/m² | 400cd/m² | Identical |
| Pixel Pitch | 0.21075 x 0.21075 mm | 0.2115 x 0.2115 mm | Very similar |
| Backlight | LED | LED | Identical |
| Display Colors | 10-bit, 1.07 billion colors | 12-bit, 68.7 billion colors | Proposed device is better |
| Luminance Calibration | Built-in calibration sensor provided | Built-in calibration sensor provided | Identical |
| Connectivity & Power | |||
| Input Signals | DVI standard 1.0, DisplayPort 1.1a | DVI standard 1.0, DisplayPort 1.1a | Identical |
| Input Termination | DVI-D (dual link) x 1, DisplayPort x 1 | DVI-D (dual link) x 1, DisplayPort x 1 | Identical |
| Display Controller | Off the shelf | Off the shelf | Identical |
| Power Requirement | AC 100 | AC 100 | Identical |
| Power Consumption/Save Mode | 56W / less than 3W | 65W / less than 3W | Higher consumption (65W vs 56W) but same save mode. Acceptable. |
| Power Management | DVI DMPM, DisplayPort 1.1a | DVI DMPM, DisplayPort 1.1a | Identical |
| USB Ports/Standard | 1 upstream (endpoint), 2 downstream / Rev. 2.0 | 1 upstream (endpoint), 2 downstream / Rev. 2.0 | Identical |
| Physical | |||
| Dimensions w/o stand (W x H x D) | Without stand: 376mm x 505mm x 98 mm | Without stand: 382mm x 490mm x 75mm | Minor differences |
| Standards Compliance | |||
| Applicable Standards | IEC 60601-1 (2005+CORR.1+CORR.2), IEC 60601-1-2 (Ed. 3:2007) | IEC 60601-1 (2005+CORR.1+CORR.2), IEC 60601-1-2 (Ed. 3:2007) | Identical |
2. Sample Size Used for the Test Set and Data Provenance
The submission refers to non-clinical tests and a comparison of technical specifications to a predicate device. There is no mention of a "test set" in the context of image data or patient studies. The performance is assessed by comparing the technical specifications of the proposed device against those of the predicate device. Therefore, no "sample size" in the conventional sense (e.g., number of images or patients) is applicable here.
The "data provenance" refers to the technical specifications of the JUSHA-C33C LCD Monitor and the EIZO RX340. This data would originate from the manufacturers' product specifications and potentially independent testing for compliance with standards. The nature of this comparative study means it is retrospective in the sense that the predicate device's specifications are already established.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No explicit ground truth established by experts is mentioned as this is a comparison of technical specifications for a display monitor, not a diagnostic algorithm. The "ground truth" for this type of submission is the documented performance characteristics of the predicate device and the new device as per engineering specifications and standard testing.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring expert adjudication for a diagnostic task.
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 submission is for an LCD display monitor, not an AI diagnostic algorithm. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI algorithm but a hardware medical device (display monitor).
7. The Type of Ground Truth Used
The ground truth used for this submission is the technical specifications and performance characteristics of the predicate device (EIZO RX340) and the proposed device (JUSHA-C33C LCD Monitor), along with compliance with international safety and electrical standards (IEC 60601-1 and IEC 60601-1-2). This is based on objective, quantifiable engineering data and regulatory standards, rather than clinical outcomes or expert consensus on image interpretation.
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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).