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510(k) Data Aggregation
(43 days)
JUSHA-M550G/JUSHA-M550/M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA-M550G has ambient brightness adapt inside. In particular, JUSHA-M550G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization 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" Mono-TFT LCD Panel - DMX0704AR0/main board/REV1.1 - JUSHA-M550G LCD Monitor software - Power Adapter - Data Cable
The document describes the JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor, intended for displaying and viewing digital images, including standard and multi-frame digital mammography and breast tomosynthesis applications.
Here's an analysis of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state numerical acceptance criteria in a table format but outlines the performance tests conducted, implying that the device met acceptable standards for these tests. The comparison to the predicate device (BARCO MDMG-5221; K161229) is a key aspect of demonstrating substantial equivalence.
| Acceptance Criteria (Implied from Bench Testing) | Reported Device Performance (JUSHA-M550G/M550) |
|---|---|
| Angular dependency of luminance response | Met, as bench testing was conducted |
| Luminance non-uniformity characteristics (TG18 guideline) | Met, as bench testing was conducted |
| Chromaticity non-uniformity characteristics (TG18 guideline) | Met, as bench testing was conducted |
| Small-spot contrast ratio | Met, as bench testing was conducted |
| Temporal response | Met, as bench testing was conducted |
| Luminance stability | Met, as performance data was provided |
| Electrical safety (IEC 60601-1) | Complies with IEC 60601-1 standard |
| Electromagnetic compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2 standard |
Comparison to Predicate Device (BARCO MDMG-5221):
| Attribute | Predicate Device Performance | Proposed Device Performance | Discussion of Differences (from document) |
|---|---|---|---|
| Screen technology | 21.3 inches, Mono-TFT LCD Panel | 21.3 inches, Mono-TFT LCD Panel | Same |
| Resolution | 2560 x 2048 / 2048 x 2560 | 2560 x 2048 / 2048 x 2560 | Same |
| DICOM calibrated luminance | 1000 cd/m2 | 1000 cd/m2 | Same |
| Pixel Pitch | 0.165 x 0.165 mm | 0.165 x 0.165 mm | Same |
| Backlight | LED | LED | Same |
| DICOM LUT | 10-bit: 1024 | 16-bit: 65536 | The JUSHA-M550G LCD Monitor uses a color bit expansion technology to improve image display quality, the image clarity is better than the image displayed on the predicate device. |
| Luminance calibration | Built-in calibration sensor provided | Built-in calibration sensor provided | Same |
| Input signals | DVI standard 1.0, DisplayPort 1.2a | DVI standard 1.0, DisplayPort 1.2a | Same |
| Input terminational | DVI-D x 1, DisplayPort x 1 | DVI-D x 1, DisplayPort x 1 | Same |
| Display controller | Off the shelf | Off the shelf | Same |
| Power Requirement | AC 100 | AC 100 | Same |
| Power Consumption/Save Mode | 57W / less than 0.7W | 55W / less than 0.5W | The differences caused by components used in the LCD Monitor. This only shows the power consumption is different, nothing to do with the display function. |
| Power Management | DVI DMPM, DisplayPort 1.2a | DVI DMPM, DisplayPort 1.2a | Same |
| USB Ports/standard | 1 upstream (endpoint), 2 downstream / Rev. 2.0 | 1 upstream (endpoint), 2 downstream / Rev. 2.0 | Same |
| Indication for use | Same as proposed device | Same as predicate device | Same |
2. Sample size used for the test set and the data provenance
The document states that bench testing was conducted. For device performance testing of this nature (LCD monitor characteristics), the "sample size" typically refers to the number of units tested. However, this specific number is not explicitly mentioned in the provided text.
The data provenance is implied to be from the manufacturer's internal testing facilities (Nanjing Jusha Display Technology Co., Ltd) and is retrospective in the sense that the results were submitted for regulatory review after the tests were completed. There is no information about the country of origin of the data itself in terms of medical images or patient information, as this device is a display monitor and not an AI algorithm processing medical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device. The JUSHA-M550G/M550 is an LCD monitor for displaying images, not a diagnostic or interpretive AI algorithm. Therefore, there is no "ground truth" to be established by medical experts for its performance, beyond ensuring it accurately and consistently displays existing medical images. The performance is assessed against technical specifications and conformity to standards like TG18.
4. Adjudication method for the test set
Not applicable. As explained above, for an LCD monitor's performance testing, there is no "ground truth" to be adjudicated in the sense of a medical diagnosis. The performance is evaluated based on objective technical measurements.
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 an LCD display monitor, not an AI-powered diagnostic tool. Therefore, MRMC studies evaluating human reader performance with or without AI assistance are not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an LCD display monitor, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As explained in point 3, the concept of "ground truth" for medical diagnosis does not apply to the technical performance evaluation of an LCD display monitor. The "ground truth" for the device's technical specifications is established by predefined industry standards and measurements (e.g., DICOM standard, TG18 guideline).
8. The sample size for the training set
Not applicable. This device is an LCD display monitor and does not involve machine learning or AI algorithms that require a "training set."
9. How the ground truth for the training set was established
Not applicable. As explained in point 8, there is no training set for this device.
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