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3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls.

3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images.

The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy.

3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications. The 3Di has been modified to include the 3Di CScore -option, which is intended to process CT cardiac studies for CT Calcium scoring.

Here's a breakdown of the acceptance criteria and the study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a validation study for the 3Di CScore feature by comparing its output to a predicate device. It doesn't explicitly state numerical "acceptance criteria" in the format of a predefined threshold. Instead, it states the goal of the validation and the outcome of the comparison.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth. The study is described as a comparison against a predicate device's output, rather than against expert consensus on a dataset.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The study is a direct comparison of algorithmic outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not conducted or described. The study focuses on the device's algorithmic output compared to a predicate device's algorithmic output, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, a standalone performance assessment was done in the sense that the 3Di CScore's calculated calcium scores were compared directly to the Philips Brilliance workstation's calculated calcium scores. This is a comparison of two algorithmic outputs.

7. The Type of Ground Truth Used

The "ground truth" for the test set appears to be the output of a legally marketed predicate device (Philips Brilliance workstation) for calcium scoring. This is a comparative validation, where the predicate device serves as the reference standard.

8. The Sample Size for the Training Set

The document does not provide the sample size for the training set.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. Given the nature of the validation (comparison to a predicate device), it's possible that the 3Di CScore's development involved internal reference standards or existing clinical data, but the details are not outlined here.

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