Search Results

Ask a specific question about this device

Ask a specific question about this device

The VIEW COM is a Software Device intended to digitized and to communicate Cardiac and Cardiovascular Images from the Procedure Room to Local Network in DICOM Format.

Such Digitized Images will be visualized and archivied by independent DICOM entities.

The VIEW COM is a Software Device intended to digitized and to communicate Cardiac and Cardiovascular Images from the Procedure Room to Local Network in DICOM Format.

Such Digitized Images will be visualized and archivied by independent DICOM entities.

The provided document does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary for the "VIEW COM" device, which is an Image Digitizer and Communication System. It focuses on demonstrating substantial equivalence to predicate devices. Key sections explicitly state:

• "CLINICAL PERFORMANCE DATA: Not required for determination of substantial equivalence for this class of device." (Page 3 of 5)
• "CONCLUSION DRAWN FROM CLINICAL AND NONCLINICAL TEST DATA: Not required for determination of substantial equivalence for this class of device." (Page 3 of 5)

Therefore, none of the requested information regarding acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details are available in this document. The manufacturer was not required by the FDA to perform such studies for the 510(k) clearance of this particular device.

Ask a specific question about this device

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.

Ask a specific question about this device

Vascular image archiving, processing, analysis, management and communication.

The VIEW Archiving Station represents the first generation of Electromed International's vascular image archiving and communication stations. The VIEW Archiving Station is intended for vascular image archiving, processing, analysis, management, and communication as the Cinenet Cardiac Image Network with the exception of analysis which is available as an option with the Cardiac Image Management System (CIMS). Some of the features offered in the VIEW Archiving Station are: vascular image processing (zoom, panning, edge enhancement, contrast), analysis (left and right ventricular functions, quantitative coronary analysis), and communication (printing of reports and sending of exam information in DICOM or Electromed encapsulation over a local area network, including images). Images are acquired in real-time on both products.

The VIEW Archiving Station may be interfaced directly with the majority of image digitizers available in todays angiographic systems. It may be linked to video signals of 1249 lines at 25 images/sec or even 1049 lines at 30 images/sec. The video signal is then re-sampled in real time to yield a signal of 625 lines which then may be recorded on a laser video disc by the CRV.

The View Archiving Station is comprised of two principle assemblies: the Electronic Cabinet; and the User Console which is connected solely to the Electronic Cabinet. Unlike the Cinenet Cardiac Image Network which uses digital videocassettes as the archiving media, the VIEW Archiving Station archives it's images on laser video discs and the exam information on internal hard disks. Each uniquely numbered laser video disc holds approximately 48 minutes (24 per side) of recording time, 35-45 examinations. The internal hard disks encompasses records that contain patient and exam information along with the referenced video laser disk ID number, which in turn, contains the recorded images. Approximately 100,000 records can be maintained on the internal hard disks at the present time. The Cinenet Cardiac Image Network incorporates a Data Storage Library which contains anywhere from 84 to 1008 digital video cassettes for automatic retrieval, whereas the VIEW Archiving Station acts as a stand alone unit whereby the laser video discs are manually inserted when prompted.

The VIEW Archiving Station is to be connected to a 230V (±10%), 50/60Hz, 10A power source.

The configurable and add-on options being offered with the VIEW Archiving Station are: Room Loop Playback (the viewing of inages on a remote monitor in the orocedure room). Table Side Joystick (remote console in the procedure room to control the playback of recorded images); SVHS Copier (the recording of exams onto a SVHS tape); and a High Definition Printing of reports, including reference images at 1200cpi and 256 gray scale levels, via an ethernet local area network).

Since the VIEW Archiving Station can transmit information and images in a Dicom compliant format, via an ethernet local area network, a CD-R Station may be connected to record exams onto a transportable media (CD). The CD-R Station is not part of this 510(k) submission.

Since the options or combination of options, as stated above, are available as an integral part of the VIEW Archiving Station, the device will inevitably be offered in various configurations while maintaining the intended use and technological characteristics presented here within.

The provided text is a 510(k) summary for a medical device called "VIEW Archiving Station." It describes the device's intended use and claims substantial equivalence to previously marketed devices. However, this document does not contain specific acceptance criteria, details of a study proving the device meets acceptance criteria, or information on performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document states: "The VIEW Archiving Station does not in any way raise new questions of safety or effectiveness, when used as labeled, in comparison to the predicate device." This is a general statement typical of a 510(k) submission, asserting that the device is substantially equivalent to existing devices and therefore does not require new studies to demonstrate safety and effectiveness.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sized used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: This information is not present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document focuses on describing the device's features, functionality, and comparison to predicate devices for the purpose of demonstrating substantial equivalence for regulatory approval. It does not include the detailed study results and performance metrics that would be associated with acceptance criteria.

Ask a specific question about this device