(75 days)
CD writer (CD-R STATION) is intended solely for the engraving of DICOM compliant images from a local area network and the CD reader (VRS-2000) is used for viewing the images either from the CD or directly from a local area network.
The media (CD) is not to be used as an archiving media, but rather only as a transportable media to review images and reports. The internal hard disks of the CD-R Station and VRS-2000 are used only for running the software and to temporarily buffer the images / reports to and from the CD and local area network.
The CD-R STATION & VRS-2000 is comprised of two principle assemblies: a personal computer and a monitor. The CD-R STATION is to be interfaced to a local area network to receive DICOM compliant images which may then be recorded onto a CD. The VRS-2000 is a stand alone station which reads DICOM compliant images from a CD and displays them on a computer monitor. The media (CD) is not to be used as an archiving media, but rather only as a transportable media to review images and reports. The internal hard disks of the CD-R STATION & VRS-2000 are used only for running the software and to temporarily buffer the images / reports which are to and from the CD.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ELECTROMED CD-R STATION & VRS-2000:
Disclaimer: The provided document is a 510(k) summary from 1997-1998 for a CD writer and reader for digital cardiac images. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria in the modern sense of medical device validation. Therefore, many of the requested points, particularly those related to clinical performance metrics and detailed study design (like sample sizes for a test set, expert involvement, and ground truth establishment for diagnostic accuracy), are not present in this document. The focus of this 510(k) is on the device's technical specifications and intended use being similar to existing cleared devices, and its safety and effectiveness without raising new questions.
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" and "reported device performance" as typically seen in modern diagnostic device submissions with specific sensitivity/specificity thresholds is not explicitly detailed in this 510(k) summary for the CD-R STATION & VRS-2000. This device is a component of a Picture Archiving and Communication System (PACS), specifically for writing and reading DICOM-compliant images to and from CDs for transport and viewing. Its acceptance criteria would primarily revolve around its ability to:
- Successfully write DICOM-compliant images to a CD.
- Successfully read DICOM-compliant images from a CD.
- Display recorded images on a monitor.
- Maintain image quality during writing, reading, and display comparable to the source.
- Interface correctly with a local area network to receive DICOM images.
- Meet safety standards (e.g., electrical safety).
- Function without introducing new questions of safety or effectiveness compared to predicate devices.
The document does not provide a quantitative table of these criteria or specific metrics of "performance." Instead, it asserts equivalence based on the device's intended use and technological characteristics.
Study Information (Based on the provided document)
1. A table of acceptance criteria and the reported device performance:
As explained above, explicit quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) and corresponding reported performance metrics are not provided in this 510(k) summary. The "performance" described is largely functional equivalence to predicate devices and adherence to standards like DICOM.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a sample size for a test set in the context of diagnostic performance evaluation. The "testing" implied would be functional testing to ensure DICOM compliance, successful writing/reading, and display, rather than a clinical performance study with "cases."
- Data Provenance: Not applicable in the context of clinical data for a performance study. The data involved would be DICOM cardiac images from a local area network. No mention of country of origin or retrospective/prospective nature is made for any performance study data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. This information would be relevant for a diagnostic performance study where expert interpretation is used to establish ground truth for a test set. This 510(k) is for a data transport/viewing device, not a diagnostic algorithm that interprets images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. Adjudication methods are used in diagnostic performance studies to resolve discrepancies in expert interpretations. This is not the type of study presented here.
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 study was not conducted (or at least not described in this summary). This device is a basic CD writer/reader for images, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware and software for data handling, not an algorithm performing a diagnostic task in a standalone manner. Its function is to facilitate image transport and viewing for human interpretation, not to interpret images itself.
7. The type of ground truth used:
- Not applicable. Ground truth (e.g., pathology, outcomes data) is established for diagnostic devices to verify their accuracy. For this device, the "ground truth" would simply be confirmation that the image written to the CD is identical to the source image, and that the image read from the CD and displayed is identical to what was written. This validation would be technical, not clinical diagnostic ground truth.
8. The sample size for the training set:
- Not applicable. The device is not based on a machine learning model that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable. As no training set is used, no ground truth was established for it.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.