(30 days)
The Nio 2MP-20" is intended to be used in displaying digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
"The E-2620 S 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.
Nio 2MP-20" is a display system for medical viewing. It consists of 3 components: E-2620 S is a 20.1" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing. The display system can be a single-head system or multi-head system. In the iast case it contains multiple displays and display controller boards.
E-2620 S is a 20.1" grayscale LCD display for medical viewing. It is combined with NioWatch, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.
The provided 510(k) summary does not contain information about specific acceptance criteria, a study that proves the device meets such criteria, or detailed performance metrics.
This submission is a "Substantial Equivalence" determination for a medical display system, not a clinical performance study. The FDA evaluates these types of devices based on their equivalence to a predicate device already on the market, focusing on similar technological characteristics, intended use, and a demonstration that any differences do not affect safety or efficacy.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable or available in submitted document.
Here's a breakdown of what can be gleaned from the document given its nature:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not provide specific quantitative acceptance criteria or detailed performance metrics from a study that evaluates the device against such criteria. The device is a display system, and its "performance" is primarily assessed by its technical specifications and its ability to display digital images for review, similar to its predicate.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Technological Characteristics (as per substantial equivalence) | Equivalent to predicate device (Nio 2MP Medical flat panel display system for Nio 2MP-20"; MFGD 2320 20-inch 2 Megapixel grayscale display for E-2620 S) in areas of technical characteristics, general function, application, and intended use. | Nio 2MP-20": Utilizes a different LCD panel but maintains identical screen size and resolution (1600x1200 pixels) as the predicate. Other components (BarcoMed Nio board, NioWatch software) are the same. |
| E-2620 S: Contains a backlight sensor instead of a front sensor compared to the predicate, but their panels are identical. Resolution is 1600x1200 pixels. | ||
| Safety and Efficacy Impact (as per substantial equivalence) | No effect on safety or efficacy. | Any differences between the new devices and their respective predicates were determined not to affect safety or efficacy. |
| Intended Use | Display digital images for review by trained medical practitioners. Not for primary image diagnosis in mammography. | The intended use statements for both Nio 2MP-20" and E-2620 S explicitly state this. |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study involving a test set of medical images or patient data. The evaluation is based on technical specifications and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no specific "ground truth" derived from expert consensus on medical images because this is a technical equivalence submission for a display device.
4. Adjudication method for the test set
Not applicable. No test set of medical cases was used.
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. No MRMC study was conducted. These devices are display systems, not AI-powered diagnostic tools. There is no "AI assistance" being evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. These are display devices, not algorithms, and therefore standalone performance of an algorithm is not relevant.
7. The type of ground truth used
Not applicable. As this is not a study evaluating diagnostic performance on medical images, the concept of "ground truth" in the typical clinical study sense (pathology, expert consensus, outcomes data) does not apply. The "truth" in this context is the technical specifications and functional equivalence to the predicate device.
8. The sample size for the training set
Not applicable. As this is a medical display device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).