(129 days)
The Nova Radiology Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The Nova 5MP display is currently not cleared in the U.S. for use with Ful Field Digital Mammography (FFDM). The Nova 1MP, 2MP and 3MP displays are not intended for use with FFDM
The Nova - Radiology Monochrome Display is a diagnostic display.
The provided text is a 510(k) summary for a medical device called "Nova - Radiology Monochrome Display." It describes the device, its intended use, and states that it is substantially equivalent to other marketed predicate devices. However, the document does not contain acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, which is a regulatory pathway for lower-risk medical devices in the US. This process typically involves showing that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, and does not raise different questions of safety and effectiveness. It often relies on a comparison table of features and specifications rather than a new clinical study with specific acceptance criteria that the device's performance needs to meet.
Therefore, for aspects of your request that relate to acceptance criteria and performance studies, the information is not available in the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The document describes the device's technological characteristics (high resolution, LCD, monochrome, image restoration) and intended use, and lists predicate devices for comparison. It does not provide specific performance metrics or acceptance thresholds that the device was tested against in a formal study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text. A formal test set and associated data provenance are typically part of a performance study, which is not described here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available in the provided text. Ground truth and expert adjudication are relevant for studies assessing diagnostic accuracy, which is not the focus of this 510(k) submission for a display device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text.
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 and not available in the provided text. This is a passive display device, not an AI-powered diagnostic tool. MRMC studies are not relevant for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not available in the provided text. This is a display device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable and not available in the provided text.
8. The sample size for the training set
- Not applicable and not available in the provided text. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable and not available in the provided text.
Summary of available information from the provided text:
- Device Name: Nova - Radiology 18.1" Monochrome Display (1MP), Nova - Radiology 20.1" Monochrome Display (2MP), Nova - Radiology 20.8" Monochrome Display (3MP), Nova - Radiology 21.3" Monochrome Display (5MP)
- Intended Use: To display and view digital images for review and analysis by trained medical practitioners. (Note: Specific limitations for FFDM use are mentioned for different models).
- Technological Characteristics: High-resolution, Liquid Crystal Display (LCD) with image restoration for viewing and analysis of high-resolution medical images.
- Regulatory Pathway: 510(k) Premarket Notification based on substantial equivalence.
- Predicate Devices:
- Conclusion: The FDA determined substantial equivalence, allowing the device to be marketed. This determination is based on the comparison of the new device's characteristics against the legally marketed predicate devices, not on the results of a new performance study with explicit acceptance criteria.
§ 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).