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The WriteStar is designed to create convenient and efficient storage, display, and analysis of digital images of heart catheterization and other coronary procedures involving cine-film applications. The WriteStar is designed to support the cine-less cath lab environment and is meant to replace 35mm cine film, and cine projectors currently being used by the majority of cardiac catheterization laboratories. Cine film is currently being used as the permanent archival media for images acquired during heart catheterization. The WriteStar is able to function as an independent unit that accepts images from any imaging system an RS-170 video source.

The ViewStar is a review station. The ViewStar does not have the WriteStan's capability to record to a CD-R disk. The ViewStar can only read (view) a case study from a DICOM compliant CD-R disk.

The ViewStar/Write Star is able to review patient images from A CD-R disk that was previously recorded from an imaging device that uses the DICOM standard. The patient images are transferred from the CD-R disk to the internal hard disk of the WriteStar. Once the images are on the hard disk, the Cardiologist, or other qualified personnel, has the same means to review and analyze images. Analysis is provided via 3rd party industry standard software.

The WriteStar is an independent computerized system used in the cardiac catherization laboratories for managing, displaying, and analyzing digitized xray images. It has the following major components(minimally):

• IBM compatible 486/586/ or Pentium computer.
• A SVGA monitor
• HP compatible laser jet printer.
• CD-ROM/CD-R disk
• Software program developed by ComView to run on the IBM OS/2 V3.0 or higher platform.

The archival/review is designed as an accessory to legally marketed medical devices that can digitize x-ray images in the cardiac cath lab. The WriteStar provides image digitization, archival, display, and exchange media compliant to the DICOM standard. The ViewStar provides image review and analysis capabilities and retrieval of data from CD-R disc.

The WriteStar interfaces with commercially available devices that digitize and/or process cine images and or fluoro images and records these images on a 2GB or 4GB SCSI hard drives. These images are simultaneously displayed on the system console for image quality verficication.

Images are acquired from the source device via RS-170 interface. The images are then displayed for review and analysis similar to a cine film projector. As in the cine film projector, the WriteStar will display cine images of a particular patient without the use of film.

This 510(k) summary describes a digital image archival and review station called WriteStar and ViewStar. This device is a digital image archival and review station that is intended to be used in cath labs in place of cine film to store, display, and analyze images acquired during cardiac catheterization and other coronary procedures.

1. Table of acceptance criteria and the reported device performance:

The provided 510(k) summary does not include specific acceptance criteria or quantitative performance metrics for the WriteStar and ViewStar device. The submission focuses on demonstrating substantial equivalence to predicate devices based on functional similarity rather than detailed performance studies against pre-defined criteria.

2. Sample size used for the test set and the data provenance:

No specific test set or data provenance is mentioned in the provided 510(k) summary. The submission does not detail any performance studies that would involve a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

No information is provided regarding experts or ground truth establishment for a test set.

4. Adjudication method for the test set:

No information is provided regarding an adjudication method for a test set.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance:

No MRMC study information is provided. This device is a digital image archival and review station, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No information is provided about standalone algorithm performance. The device is described as a system for image management and display, implying human interaction for review and analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

No specific ground truth type is mentioned as no performance studies are detailed.

8. The sample size for the training set:

No information is provided regarding a training set sample size. The device is not described as being based on machine learning or AI models that would require a training set.

9. How the ground truth for the training set was established:

No information is provided on how ground truth for a training set was established, as no training set is mentioned.

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