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CARESTREAM Image Suite is an image management system whose intended use is to receive, process. review. display, print and archive images and data from all imaging modalities,

Tablet Viewer Software for Image Suite is used for patient management by clinicians in order to access and display patient data. medical reports, and medical images for different modalities including CR. DR. CT. MR, and US.

Tablet Viewer Software for Image Suite provides wireless and portable images for remote reading or referral purposes from web browsers including usage with validated mobile device is not intended to replace the full Mini-PACS and should be used only when there is no access to the full Mini-PACS Web Viewer.

This excludes mammography applications in the United States.

CARESTREAM Tablet Viewer Software for Image Suite is an optional feature for Image Suite Mini-PACS users. The software technology uses HTML5 which allows a browserenabled mobile device to run the software application. The user is able to access patient images and study reports from an iPad 2 mobile device anywhere through a wireless network. Tablet Viewer Software for Image Suite has a simple GUI for viewing and includes some fundamental tools such as zoom, pan, windowing, basic measurements, cine, etc. Tablet Viewer Software for Image Suite functions as an extension to Image Suite.

CARESTREAM Image Suite is a stand-alone, self-contained radiographic imaging system designed to provide a low-cost platform to manage medical images, reports, patient/exam information and workflow in small clinics. The system performs capture, processing, review, archive, and printing of radiographic images as well as report writing and printing and is designed to run on a PC workstation. CARESTREAM Image Suite is designed to be simple and intuitive to both use and service.

CARESTREAM Image Suite connects with hardware including multiple radiographic image capture devices (CR and / or DR detectors) attached to a PC workstation with either a standard or a high-resolution monitor. CARESTREAM Image Suite is designed as a hardware-independent system and may be interfaced with verified and validated imaging modalities from both Carestream Health and 3rd party vendors, as well as Carestream Health PACS systems, and other 3rd party PACS systems. The Image Suite system can directly acquire an image from Carestream Health acquisition devices and is PC and monitor independent.

This document describes the Carestream Tablet Viewer Software for Image Suite. However, it does not contain a study with detailed acceptance criteria and reported device performance in the format requested. The provided text notes that a "Clinical Assessment of Tablet Viewer Software for Image Suite on the Apple iPad 2" was performed, along with bench testing and functional QA testing, but it does not present the results of these assessments in a structured acceptance criteria table or provide the specific details of a clinical study as requested.

Therefore, many of the requested fields cannot be filled.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document mentions several types of testing but does not provide a formal table of acceptance criteria with corresponding performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified for the "Clinical Assessment." The bench testing would likely not involve a case sample size.
• Data Provenance: Not specified.
• Retrospective/Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not specified.

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:

• Not specified. The assessment described does not appear to be an MRMC comparative effectiveness study involving AI assistance for human readers. This device is a viewer, not an AI diagnostic tool.

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

• Not applicable in the typical sense as this is a viewing software, not an AI algorithm performing diagnostic tasks. The "standalone" performance here would relate to its functionality as a viewer, which was generally described as "tested" or "demonstrated suitability."

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

• Not specified in detail. The "Clinical Assessment" likely involved expert review of the displayed images, but the method for establishing ground truth (e.g., comparison to full PACS, original diagnostic reports) is not elaborated upon.

8. The sample size for the training set:

• Not applicable. This device is viewing software, not an AI algorithm that undergoes training.

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

• Not applicable, as there is no training set for this viewing software.

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