(48 days)
The MDNC 3120 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The MDNC 3120, which is part of the Nio Color 3MP system, will be marketed separately.
The Nio Color 3MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The Nio Color 3MP, containing the display MDNC 3120, the software MediCal QAWeb Agent and a graphic board, will be marketed as separate device.
MDNC 3120 is a 20.8" color LCD display for medical viewing. It is combined with MediCal QAWeb Agent, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.
Nio Color 3MP is a display system for medical viewing. It consists of 3 components: MDNC 3120 is a 20.8" color LCD display. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control. The system also contains a fast high-resolution display controller board that plugs into a PACS workstation computer. Standard the system is delivered with the MXRT 2100 board, but the user can opt for another type of display controller board (MXRT 5100 or MXRT 7100). The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.
This document describes two similar devices, MDNC 3120 and Nio Color 3MP. Both are medical display systems. The provided text is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of filing does not typically include detailed studies proving performance against acceptance criteria in the way a new, novel device might. Instead, the focus is on a comparison to existing devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for this device is largely absent because it's not a requirement for a 510(k) substantial equivalence submission for a display system. The "study" here is essentially the comparison to a predicate device.
Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the 510(k) summary in terms of a formal “acceptance criteria” and “reported device performance” table for the new device. The acceptance criteria for a 510(k) for a display device are typically centered around demonstrating substantial equivalence to a predicate device, meaning it performs as safely and effectively.
The "performance" is implicitly deemed equivalent to the predicate device E-2320C (for MDNC 3120) and Color Nio 2MP (for Nio Color 3MP) because the manufacturer states: "The basic specifications and functions, however, are the same." and "Any difference between both devices does not affect safety or efficacy."
Key Specifications mentioned for the new devices:
- Resolution: 2048 x 1536 pixels
- Display type: 20.8" color LCD (MDNC 3120)
- Software: MediCal QAWeb Agent (optimizes for DICOM-compliant viewing, sets display function, test patterns, calibrates, views controller info).
- Display Controller (for Nio Color 3MP system): 3-megapixel flat panel display, 32-bit display controller, up to 64-bit color.
Comparison to Predicate:
The document states that the new devices have "a different LCD panel, other electronic and mechanical parts" and (for Nio Color 3MP) "The software is a new version." However, it asserts that "The basic specifications and functions of all the parts are the same" and "Any difference between both devices does not affect safety or efficacy." This forms the basis of their claim of substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable. This is not a study involving patient data or images in the traditional sense for assessing diagnostic performance. The "test" for a display device in a 510(k) is usually a technical comparison to a predicate device, focusing on specifications and functionality.
- Data provenance: Not applicable. No clinical or image data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. Ground truth, in the context of diagnostic performance, is not established for this type of device submission. The device is a display, not an AI algorithm performing diagnosis.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: 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
- MRMC study: No. This is a display device, not an AI-powered diagnostic tool. Such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: No. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not applicable.
8. The sample size for the training set
- Sample size: Not applicable. This device does not use a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Ground truth establishment: Not applicable.
In summary:
The provided document is a 510(k) premarket notification for medical display systems. The "study" for this type of device, as presented here, is a demonstration of substantial equivalence to existing predicate devices based on a comparison of technical specifications, intended use, and general functionality. It does not involve clinical performance studies with patient data, diagnostic accuracies, or expert-adjudicated ground truth, as those are typical for diagnostic imaging algorithms or novel clinical devices, not medical display systems. The acceptance criteria are implicitly met by demonstrating that the new devices' characteristics are "substantially equivalent" to the predicate devices and that any differences do not affect safety or efficacy.
§ 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).