(88 days)
Exhibit is a software package, which may be marketed as a software only solution, as well as in coniunction with standard PC hardware. Exhibit is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to Exhibit are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by Exhibit to create JPEG and wavelet images follow known and accepted protocols.
lmages sent to Exhibit can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The Exhibit applet can be used for the purposes of viewing images over a hospital intranet, or over the internet from a remote location. Images stored on Exhibit are transient, as Exhibit is not intended to be an archiving device.
Exhibit uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Exhibit.
Exhibit is a software package, which may be marketed as a software only solution, as well as in conjunction with standard PC hardware. Exhibit is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to Exhibit are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by Exhibit to create JPEG and wavelet images follow known and accepted protocols.
lmages sent to Exhibit can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The Exhibit applet can be used for the purposes of viewing images over a hospital intranet, or over the internet from a remote location. Images stored on Exhibit are transient, as Exhibit is not intended to be an archiving device.
Exhibit uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Exhibit.
The provided document, K982769, for Mitra Imaging, Inc.'s Exhibit software, is a 510(k) summary submitted to the FDA. It does not contain a detailed study demonstrating the device meets specific performance acceptance criteria. Instead, it focuses on establishing substantial equivalence to a predicate device (Algotec Systems Ltd.'s MediSurf).
Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this document.
Here's a breakdown of what can be extracted and what is explicitly not available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than specific performance metrics with acceptance criteria.
The substantial equivalence chart (Section 1.9) compares features:
| Specification | Exhibit (This submission) | MediSurf (K971347) |
|---|---|---|
| Graphical User Interface | Yes | Yes |
| Uses Java programming language | Yes | Yes |
| Applets viewed inside web browser | Yes | Yes |
| Applets stored on remote server | Yes | Yes |
| Communications | TCP/IP | TCP/IP |
| Image Review | Window Level/Flip/Rotate/Zoom | Window Level/Flip/Rotate/Zoom/Pan |
| Server Platform | PC - Windows NT | UNIX |
| Client Platform | Any Java-compatible web browser | Any Java-compatible web browser |
| JPEG for thumbnail view | Yes | No |
| Wavelet compression for transmission of images | Yes | Yes |
2. Sample size used for the test set and the data provenance
This information is not provided. As no specific performance study is detailed, there's no mention of a test set size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided, as no specific performance study is detailed.
4. Adjudication method for the test set
This information is not provided, as no specific performance study is detailed.
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
This information is not provided. The Exhibit software is described as a PACS Teleradiology System for viewing images. It is not presented as an AI-assisted diagnostic tool that would typically undergo an MRMC study to show improvement for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study, in the sense of demonstrating a diagnostic algorithm's accuracy, was not described or performed for this submission. The "effectiveness" mentioned (Section 1.8) refers to the software's ability to perform its stated functions (receive, convert, display DICOM images), with "extensive testing... performed by programmers, by non-programmers, quality control staff, and by potential customers," rather than a formal clinical or diagnostic performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/provided, as no specific performance study requiring ground truth for clinical or diagnostic accuracy is detailed. The "ground truth" implicitly assumed is that the software correctly receives, converts, and displays images as intended by its design.
8. The sample size for the training set
This information is not provided. The software is not described as an AI/ML model that would require a distinct training set for its core functionality.
9. How the ground truth for the training set was established
This information is not applicable/provided, as the device is not an AI/ML model requiring a training set with established ground truth in the typical sense.
Summary of Device and its "Proof of Effectiveness" from the document:
The Exhibit software is a PC-based, DICOM-compliant PACS device that receives and displays DICOM images by converting them to web-browser compatible formats (JPEG and wavelet). Its intended use is for viewing images over an intranet or internet from a remote location. It is not intended for archiving.
The "study that proves the device meets the acceptance criteria" is primarily the claim of substantial equivalence to the predicate device, Algotec MediSurf (K971347). The manufacturer argues that Exhibit's intended use and technological characteristics are "virtually identical" to the predicate device, and any differences "have no significant influence on safety or effectiveness."
The document also mentions "extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers." This type of testing would assess the software's functional correctness, stability, and usability, but it's not described as a formal validation study with specific acceptance criteria beyond general functionality. The level of concern for the device is categorized as "minor," implying that its failure would not be expected to result in death or injury to a patient, which aligns with its function as an image viewing and distribution system rather than a diagnostic tool.
§ 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).