(61 days)
The MODALIXX G202MP display is intended for use by physicians and the medical industry for diagnostic imaging applications along with the Picture Archiving Communication System (PACS). The Modalixx G202MP is also intended as a direct replacement for ageing CRT medical monitors.
The MODALIXX G202MP display is intended to be used in displaying and viewing digital images for review by trained medical practitioners before the digital images are sent to other diagnostic displays. Modalixx G202MP is not meant to be used for mammography applications.
Modalixx G202MP is a grayscale High Bright medical LCD solution for modality CRT monitor replacement. G202MP will Auto Sync to any legacy grayscale or color analog modality and up scales it to clear, sharp, and vivid high bright 2 mega pixel resolution to provide the best diagnostic medical imaging applications.
Armed with a complete set of input options, G202MP is compatible to nearly all medical modality applications. Modalixx G202MP medical LCD is capable of accepting any combination of BNC connections, including single to 5 BNC, as well as D-SUB 15. At any resolution from 525- 1600 horizontal pixels, G202MP can accept from low line to high line video signals through BNCs or VGA (D-sub15) inputs. This attribute of the Modalixx G202MP can be utilized in different types of medical imaging and application modalities as a true CRT imaging replacement.
The provided document is a 510(k) summary for the MODALIXX G202MP, a medical LCD monitor. It details the device's technical specifications, intended use, and comparison to a predicate device to establish substantial equivalence. However, it does not describe an acceptance criteria study in the way a clinical study would for an AI/CAD product.
Instead, the document focuses on demonstrating that the MODALIXX G202MP is substantially equivalent to a previously cleared device (Totoku ME201L/r, K021738) based on technical specifications and performance characteristics, rather than clinical performance (e.g., sensitivity, specificity for diagnostic tasks).
Therefore, I cannot populate the table and answer the study-specific questions as there is no such study described in the provided text. The "acceptance criteria" for this device are primarily based on meeting safety and EMC standards, and showing improved technical specifications (contrast ratio, brightness) compared to the predicate device, not on diagnostic performance in a clinical setting.
Here's a breakdown of what is available from the document, framed as if it were an acceptance criteria study, though it's important to reiterate it's a technical equivalence argument:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly for equivalence to predicate) | Reported Device Performance (MODALIXX G202MP) |
|---|---|---|
| Device Type | Grayscale LCD Monitor | Grayscale High Bright medical LCD |
| Screen Size | 20.1" | 20.1" |
| Resolution | 2 Mega Pixel | 2 Mega Pixel |
| Contrast Ratio | Equivalent to or better than predicate (1000:1) | 1500:1 (Higher than predicate) |
| Brightness | Equivalent to or better than predicate (700 CD/M2) | 1000 CD/M2 (Higher than predicate) |
| Input Options | Capable of accepting various medical modality inputs | Complete set of input options (single to 5 BNC, D-SUB 15) |
| Compatibility | Compatible with legacy grayscale/color analog modalities | Auto Sync to any legacy grayscale or color analog modality |
| Medical Safety | Compliance with UL 60601-1, CE | UL 60601-1, CE Compliant |
| EMC | Compliance with CSA-C22.2 | CSA-C22.2 Compliant |
| Intended Use | For diagnostic imaging applications with PACS; direct replacement for aging CRT monitors; not for mammography. | For diagnostic imaging applications with PACS; direct replacement for aging CRT monitors; not for mammography. |
2. Sample size used for the test set and the data provenance
- Not applicable. This document describes a technical comparison and regulatory submission for a medical display, not a clinical study involving a test set of data. The "test set" would be the device itself tested against technical specifications and safety standards.
- Data provenance: The performance data reported (contrast ratio, brightness) would be based on internal testing and specifications of the MODALIXX G202MP.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in the context of diagnostic accuracy is not relevant for this type of device submission. The "ground truth" here is adherence to technical specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used in clinical studies to establish a consensus ground truth, which is not relevant for a display device's technical specifications.
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. This document describes a medical display, not an AI or CAD system. Therefore, an MRMC study and effects on human reader performance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This document describes a medical display, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for this device's submission is its adherence to technical specifications, safety standards (UL 60601-1, CSA-C22.2, CE), and functional equivalence to the predicate device.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" as this is not an AI/ML device.
In summary, the provided document demonstrates the MODALIXX G202MP's substantial equivalence to a predicate device based on its technical specifications (brightness, contrast, resolution, inputs) and compliance with safety and EMC standards, rather than proving its diagnostic performance through a clinical efficacy study. Therefore, most of the requested information regarding clinical study methodology is not present.
§ 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).