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The CARESTREAM Vue PACS is an image management system whose is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, retrieve and display images and data from all hospital modalities and information systems. The system is to be used by trained professionals including, but not limited to, physicians and medical technicians.

The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.

The system contains a Perfusion module with interactive tools to analyze and compare Computed Tomography Perfusion (CTP) and MR Perfusion (MRP) images of adult patients. Blood perfusion parameters are automatically calculated and displayed as a set of perfusion maps and perfusion tables include the calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

The system contains a Diffusion Module with interactive tools to ease the process of analyzing and comparing MR Diffusion Weighted images (DWI) and MR Diffusion Tensor Imaging (DTI) of adult patients. This module is used to visualize local water diffusion properties from the analysis of diffusion- weighted MRI data.

The system supports Subtractive tools to aid with the analysis of Digital Subtraction Angiography (DSA) images in both interventional radiology and cardiology. Subtraction automatically subtracts a mask from contrast frames of an X-Ray Angiography study for visualization of vascular anatomy and pathology of adult patients.

CARESTREAM Vue PACS is an image management system. It provides functionality to allow remote site access to image and patient data enabling diagnostic reading through industry standard interfaces. The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images.

The modification to the Vue PACS device described in this submission includes the addition of the MR Perfusion and Diffusion Module.

The provided document describes the Carestream Vue PACS system, specifically focusing on the addition of MR Perfusion and Diffusion Modules. It outlines the performance testing conducted to demonstrate substantial equivalence to a predicate device (Olea Sphere v3.0). However, the document primarily discusses high-level details of the study rather than providing specific, granular acceptance criteria and detailed performance results with numerical thresholds.

Below is a structured attempt to answer your questions based on the provided text, supplemented with interpretations where specific details are missing (and noted as such).

Acceptance Criteria and Device Performance

The document states, "Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device." However, the exact, quantifiable acceptance criteria are not explicitly listed. The study objective was to "compare the similarity of the parametric maps," implying that the acceptance criterion was a qualitative or quantitative measure of this similarity, but no specific threshold (e.g., a certain correlation coefficient, a maximum allowed difference) is provided.

Given the available information, the table would look like this, with the understanding that specific numerical criteria are not provided in the text:

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not specified. The document only mentions "A Clinical study was performed."
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

   • This was a comparative study between an investigational device and a predicate device, focusing on the "similarity of the parametric maps." It doesn't appear to establish a ground truth through expert consensus in the traditional diagnostic sense (e.g., identifying disease vs. no disease). Instead, the "ground truth" seems to be conceptually based on the output of the predicate device.
   • Therefore, the number of experts and their qualifications for establishing ground truth are not applicable/not mentioned in the context of this study as described.

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

   • Adjudication methods are typically used when multiple human readers interpret cases and their agreement or disagreement needs to be resolved to establish a "ground truth" or consensus. Since this study focused on comparing the algorithmic output (parametric maps) of two systems, and not on human interpretation needing resolution, adjudication methods are not applicable/not mentioned.

4. 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 assessing human reader improvement with AI assistance was not done based on this document. The study explicitly states its objective was to "compare the similarity of the parametric maps of MR DSC-Perfusion (Perfusion Module), MR DWI (Diffusion Module) and MR DTI (Diffusion Module) in Carestream Vue PACS ("investigational device") to the Olea Sphere PACS with Perfusion and DWI Modules ("predicate device")." This describes a comparison of the software's output, not a human reader performance study.

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

   • Yes, the primary clinical study described was effectively a standalone comparison between the investigational device's algorithmic output and the predicate device's algorithmic output. It focused on the "similarity of the parametric maps" generated by the respective modules, which implies direct algorithmic comparison rather than assessing human-in-the-loop performance.

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

   • As interpreted above, the "ground truth" in this comparative study was essentially the outputs (parametric maps) generated by the predicate device (Olea Sphere v3.0). The study aimed to show that the investigational device's outputs were "similar" or "substantially equivalent" to those of the legally marketed predicate. This is not a ground truth derived from pathology, expert consensus on disease, or outcomes data.

7. The sample size for the training set:

   • The document describes a "Clinical study" for validation and "non-clinical (bench) testing" for verification. It does not mention a training set or details about the development of the algorithms. The focus is purely on the validation of the integrated modules. Therefore, the sample size for the training set is not provided.

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

   • Since the document does not mention details about the training set or algorithm development, how ground truth for the training set was established is not provided.

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