(15 days)
1.3MP Medical Monochrome Reference Display, MDM1900-1NG MDM1900-1NR is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
Medical Display, MDM1900-1NG is a 19" monochrome LCD monitor that displays image for medical use. It provides 1.3 mega pixel (1280 x 1024/1024 x 1280) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
The provided document describes a 510(k) submission for a medical display, the MDM1900-1NG (1NR), and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain a study demonstrating device performance against specific acceptance criteria in the way one would for a diagnostic algorithm or a novel medical device with new features.
Instead, the submission for this medical display is based on establishing equivalence to an existing device (RadiForce G22 19.6" Class Monochrome LCD Monitor by EIZO NANAO CORPORATION, K041597) by showing similar characteristics and intended use, and no new questions of safety or effectiveness.
Therefore, many of the requested details about acceptance criteria and a study proving their fulfillment are not present in this type of 510(k) submission for a display monitor.
However, I can extract the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a display monitor establishing substantial equivalence, explicit "acceptance criteria" for a study demonstrating diagnostic performance are not provided. The criteria for equivalence are based on the device's technical specifications and intended use being similar to the predicate.
| Feature / Criterion | Acceptance Criteria (implied by predicate) | Reported Device Performance (MDM1900-1NG) |
|---|---|---|
| Intended Use | Displaying images for review and analysis by trained medical practitioners for diagnosis in CT, MRI, HIS, and PACS. Not suitable for digital mammography. | Displaying images for review and analysis by trained medical practitioners for diagnosis in CT, MRI, HIS, and PACS. Not suitable for digital mammography. |
| Device Type | 19.6" Monochrome LCD Monitor | 19" monochrome LCD monitor |
| Resolution | (Predicate not explicitly stated, but assumed to be adequate for medical imaging) | 1.3 mega pixel (1280 x 1024 / 1024 x 1280) |
| Grayscale | Adjustable gamma grayscale for precise diagnosis | Adjustable gamma grayscale for more precise diagnosis |
| Interaction with Patient | No contact with patient | No contact with patient |
| Control of Life-Sustaining Device | Does not control life-sustaining device | Does not control life-sustaining device |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission does not involve a diagnostic performance study with a test set of images. It is a review of the device's technical specifications and intended use against a predicate device.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment for a test set of images was performed or reported as part of this submission. The "ground truth" for the device's equivalence is based on regulatory review of technical specifications.
4. Adjudication method for the test set
- Not applicable.
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 MRMC study was conducted or reported. This device is a display monitor, not an AI or CAD system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a display monitor, not an algorithm.
7. The type of ground truth used
- Not applicable in the context of diagnostic performance. The "ground truth" for this 510(k) application is the established regulatory framework for medical device equivalence, relying on comparison of technical specifications and intended use to a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This device is a display monitor, not an AI system that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).