(15 days)
The Nio Color 3MP LED Medical Flat Panel Display System is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The display may be used in dental applications.
The MDNC-3421 is a derivative of the MDNC-3321. The modifications are:
✓ PLD panel instead of NLT panel
✓ Change in packaging (smaller size)
✓ Updated firmware
✓ Change in type of material from steel to aluminum (inside metal housing)
✓ For the dental radiology market, this display will be marketed with the screen in landscape orientation
Here's an analysis of the acceptance criteria and study information based on the provided document:
This document is a 510(k) premarket notification for a medical display system, which often focuses on demonstrating substantial equivalence to a predicate device rather than extensive clinical studies for novel technologies.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of AI/CADe devices. Instead, it demonstrates substantial equivalence by comparing the new device (MDNC-3421) to a predicate device (MDNC-3321) based on technical specifications and performance testing. The "reported device performance" is implicitly shown by the new device meeting or exceeding the specifications of the predicate device and showing no new safety or performance issues.
| Acceptance Criteria (Inferred) | Reported Device Performance (MDNC-3421) |
|---|---|
| Technological Characteristics (Similar to Predicate): | |
| Screen technology | TFT AM Color LCD IPS |
| Active screen size (diagonal) | 540 mm (21.3") |
| Active screen size (H x V) | 433 x 325 mm (17.0 x 12.8") |
| Aspect ratio (H:V) | 4:3 |
| Resolution | 3MP (2048 x 1536) |
| Pixel pitch | 0.2155 mm |
| Color imaging | Yes |
| Gray imaging | Yes |
| Viewing angle (H, V) | 176° |
| Uniform Luminance Technology (ULT) | Yes |
| Per Pixel Uniformity (PPU) | No |
| Ambient Light Compensation (ALC) | No |
| Backlight Output Stabilization (BLOS) | Yes |
| Maximum luminance | 800 cd/m² |
| DICOM calibrated luminance (ULT off) | 400 cd/m² |
| Contrast ratio (typical) | 1400:1 |
| Response time (Tr + Tf) | 40 ms |
| Video input signals | DVID Dual Link, DisplayPort |
| USB ports | 1 upstream (endpoint), 2 downstream |
| USB standard | 2.0 |
| Power consumption (nominal) | 50W |
| Power save mode | Yes |
| Dimensions with stand (W x H x D) | Portrait: 378 x 528 |
| Dimensions w/o stand (W x H x D) | Portrait: 378 x 491 x 84 mm, Landscape: 491 x 378 x 84 mm |
| Net weight with stand | 12.8 kg |
| Intended use | Displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. |
| Performance (Demonstrated Equivalence/Superiority for Modifications): | |
| PLD panel instead of NLT panel | PPVR (Product Producibility Validation Report) confirms performance. |
| Change in packaging (smaller size) | Environmental tests confirm performance. |
| Updated firmware | Firmware tests confirm performance. |
| Change in type of material from steel to aluminum (inside metal housing) | Environmental tests confirm performance. |
| Marketing in landscape/portrait orientation | Clinical study (mentioned, but details not provided in this excerpt). |
| Electrical Safety | IEC 60601-1 compliant |
| EMC | IEC 60601-1-2 compliant |
| Overall Conclusion: | Device has similar or superior characteristics compared to the predicate and did not reveal new issues of safety and performance. |
2. Sample size used for the test set and the data provenance
The document primarily describes bench testing and, for one specific aspect, mentions a "Clinical study."
- Bench Tests (for hardware/firmware changes, safety, and EMC): No specific sample sizes (e.g., number of displays tested) are provided for tests like PPVR, Environmental tests, Firmware tests, Electrical Safety (IEC 60601-1), and EMC (IEC 60601-1-2). These are typically engineering validation tests. The provenance is internal to the manufacturer's testing process.
- Clinical Study (for landscape/portrait orientation marketing): A "Clinical study" is mentioned for validating the marketing of the display in landscape/portrait orientation. However, no details are provided regarding the sample size, data provenance (e.g., country of origin, retrospective/prospective nature), or the methodology of this study. This suggests it was likely a usability or preference study relevant to display orientation, rather than a clinical trial assessing diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Given that the core of the submission relies on demonstrating substantial equivalence through technical specifications and bench testing, rather than a diagnostic performance study, the establishment of "ground truth" by medical experts is not a primary focus here. The clinical study mentioned is too briefly described to extract this information.
4. Adjudication method for the test set
This information is not provided in the document. As noted above, the predominant testing described is bench testing, where adjudication by medical experts isn't applicable in the same way as in a diagnostic study.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not described or implied in this document. This device is a medical display system, not an AI/CADe diagnostic algorithm. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study of an algorithm was not done. This device is a display monitor, not an algorithm.
7. The type of ground truth used
For the bench tests, the "ground truth" consists of engineering specifications, industry standards (e.g., DICOM, IEC 60601-1), and established performance metrics (e.g., luminance, contrast ratio, response time). These are not expert consensus, pathology, or outcomes data. For the mentioned "clinical study," the type of ground truth is not specified due to the lack of detail.
8. The sample size for the training set
This information is not applicable as this device is a medical display system, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
§ 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).