(14 days)
The family of R2 Image Display Units with UDS software is intended to display low resolution, non-diagnostic medical images with annotations such as precomputed regions-of-interest or pre-computed CAD marks from medical scanning devices.
The R2 family of Image Display Units are a combination of dedicated computer software and hardware. The System uses an off-the-shelf personal computer with Windows-based CPUs, a hard drive, and various sizes of off the shelf monitors. Despite the variability in physical dimensions, all monitor display units have the identical functional specifications. R2 Uniform Image Display Software (UDS) is provided with all R2 image display units. This version of display software provides an updated user interface and CAD mark display features
The provided text for K050667, a 510(k) Premarket Notification for the R2 Family of Image Display Units with Uniform Display Software (UDS), does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria.
The 510(k) summary explicitly states:
"The family of Image Display Units with UDS Software will undergo design verification tests for conformance with specifications."
This indicates that design verification tests are planned or will be conducted to ensure the device meets its specifications, but the results or details of these tests are not provided within this document. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological specifications, rather than presenting a performance study with detailed acceptance criteria.
Therefore, many of the requested sections (Table of acceptance criteria, sample size, ground truth, MRMC study, standalone performance) cannot be filled with information from the provided document.
Here's a summary of what can be extracted based on the provided text, and where information is missing:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided document.
- Reported Device Performance: Not reported in the provided document, as performance studies are not detailed.
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable as a formal performance test set is not described.
- 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 as a formal performance test set with expert-established ground truth is not described.
4. Adjudication method for the test set
- Not applicable as a formal performance test set with adjudication is not described.
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, an MRMC comparative effectiveness study was not done or at least not described in this document. The device is an "Image Display Unit" intended to display images and CAD marks, not to provide AI assistance for diagnostic interpretation that would typically necessitate such a study in 2005.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study was not done or at least not described in this document. The device's intended use is to display images and pre-computed CAD marks, implying it's a display tool, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable as a formal performance test set with ground truth is not described.
8. The sample size for the training set
- Not applicable as the document does not describe the development or training of any algorithm within the "Image Display Unit" beyond its display functionality. It is a display unit for pre-computed marks.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as above.
Conclusion:
The K050667 submission primarily focuses on demonstrating "substantial equivalence" of the R2 Image Display Units with UDS to existing predicate devices based on their intended use (displaying low-resolution, non-diagnostic medical images with annotations or CAD marks) and technological specifications. It states that design verification tests will be conducted for conformance with specifications, but the results, specific acceptance criteria, or any clinical performance studies are not detailed within this 510(k) summary. This type of submission relies on the similarity to legally marketed devices rather than extensive new clinical performance data.
§ 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).