(30 days)
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.
| Criterion Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Calcium Scoring Output | The 3Di CScore output should be "very similar" to the output of the Philips Brilliance workstation (the predicate device). | "The comparison results demonstrate that the 3Di and the Brilliance are very similar in terms of calcium scoring." |
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).