(81 days)
The KIMAX ™ Remote Viewing Station software and hardware (RVS) are intended to allow physicians to view static or dynamic digital images from radiographic and other medical imaging equipment. The RVS includes a high-performance computer, data storage devices, a high-resolution monitor and software to: 1) accept AVI images or import other image formats; 2) allow physician to quickly locate and display images; 3) adjust contrast and brightness, apply filters to enhance the images, zoom in on selected features of interest, pan to selected areas, and annotate images; 4) print out selected images; and 5) create reports that include text and annotated images. The RVS is intended to be used in the clinical workspace of a practicing physician.
The KIMAX ™ Remote Viewing Station software and hardware (RVS) includes a high-performance computer, data storage devices, a high-resolution monitor and software.
Here's an analysis of the provided text to extract the acceptance criteria and study information:
Based on the provided text, it's not possible to fully detail the acceptance criteria and the study that proves the device meets those criteria because the document is a 510(k) clearance letter from the FDA, not the full 510(k) application or a study report itself. The 510(k) letter primarily confirms substantial equivalence to a predicate device and outlines regulatory responsibilities.
However, I can extract what is available and highlight what's missing, based on the typical requirements for and contents of a 510(k) submission.
Missing Information:
The provided document is the FDA's clearance letter for the KIMAX™ Remote Viewing Station, not the detailed submission itself. As such, it does not contain the specific acceptance criteria, comprehensive study details, or performance metrics beyond a general statement of intended use. The letter states, "We have reviewed your Section 510(k) premarket notification of intent to market the device...and have determined the devices is substantially equivalent (for the indications referenced above...)." This indicates that the manufacturer provided data, but the data itself is not within this letter.
Therefore, the tables and detailed points below will reflect this limitation, categorizing information as "Not Provided in Document" when it's absent from the supplied text.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The clearance is based on "substantial equivalence" to a predicate device, meaning its performance for its intended use is considered comparable and within acceptable safety and effectiveness limits as proven by the submission. The "Intended Use" section outlines the functional capabilities the device is designed to perform.
| Acceptance Criterion (Implicit from Intended Use) | Reported Device Performance (as implied by FDA Clearance) |
|---|---|
| View static or dynamic digital images from radiographic and other medical imaging equipment | Substantially equivalent to legally marketed PACS devices for this function. |
| Accept AVI images or import other image formats | Substantially equivalent to legally marketed PACS devices for this function. |
| Quickly locate and display images | Substantially equivalent to legally marketed PACS devices for this function. |
| Adjust contrast and brightness | Substantially equivalent to legally marketed PACS devices for this function. |
| Apply filters to enhance images | Substantially equivalent to legally marketed PACS devices for this function. |
| Zoom in on selected features | Substantially equivalent to legally marketed PACS devices for this function. |
| Pan to select regions of interest | Substantially equivalent to legally marketed PACS devices for this function. |
| Annotate images | Substantially equivalent to legally marketed PACS devices for this function. |
| Print out selected images | Substantially equivalent to legally marketed PACS devices for this function. |
| Create reports that include text and annotated images | Substantially equivalent to legally marketed PACS devices for this function. |
| Use in the clinical workspace of a practicing physician | Substantially equivalent to legally marketed PACS devices for this context. |
Study Details and Ground Truth Establishment
The provided 510(k) clearance letter does not contain the detailed study information regarding device performance. This information would typically be part of the original 510(k) submission that the FDA reviewed.
- Sample size used for the test set and the data provenance: Not provided in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in the document.
- 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 / Not provided. The KIMAX™ Remote Viewing Station is described as "software and hardware" for viewing and manipulating images, not an AI-assisted diagnostic tool that would typically undergo an MRMC study for AI enhancement. Its purpose is a PACS-like viewing station.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a "Remote Viewing Station," implying human interaction is integral to its intended use. It's a display and manipulation tool, not an autonomous diagnostic algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in the document. For a viewing station, ground truth might relate to image fidelity, display accuracy, or function verification, rather than clinical diagnostic accuracy per se.
- The sample size for the training set: Not applicable. The KIMAX™ Remote Viewing Station, as described, is not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. It's software and hardware for image display and manipulation.
- How the ground truth for the training set was established: Not applicable, as it's not a trained AI/ML device.
§ 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).