(14 days)
iConnection™ 3D' is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. In addition, the iConnection system has the following specific intended uses:
Advanced Vessel Analysis is an option within the iConnection system intended to aid clinicians in the study and analysis of selected vessels, the inspection of circulatory anatomy, the quantification of stenosis, distance measurements and cross-sectional diameters, volume measurements, and assist in the planning and monitoring of vascular therapies. The feature operates with CT and MRI data.
Pet Visualization is an option within the iConnection system that provides for the overlay, inspection, and measurement of two different image modalities (primarily directed at PET/CT or PET/MR datasets). This option includes the ability to measure Standard Uptake Values on PET datasets.
The overlay operation enables clinicians to obtain a better understanding of the joint information that would otherwise have to be compared separately. It is important to note that the clinician retains the ultimate responsibility for making pertinent diagnosis based on their standard procedures, including visual comparison of separate images.
Collaboration Mode is a capability within the iConnection system that allows multiple users to collaboratively interact with iConnection system features and tools.
iConnection provides an online enterprise solution for secure access and on-demand distribution of medical images, reports, clinical applications and services. The iConnection System offers fully integrated diagnostic reviewing, volumetric processing, and collaborative tools in a clinically familiar ubiquitous diagnostic environment. It enables its users, radiologists and referring physicians, to streamline clinical workflow and access, review, and visualize patient data with high-end applications.
The iConnection system has an applications server which provides centralized data management and application processing and a thin-client web-based viewer.
An iConnection system consists of the follow components: 1) a server; 2) one or more client computers (referred to as client); and 3) the Client/Server communication.
The provided text is a 510(k) premarket notification for the iConnection, Version 3.2.0.0 Medical Image Processing Software. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices. However, the document does not detail specific acceptance criteria, a clinical study design, or reported device performance against such criteria. It focuses on regulatory approval based on substantial equivalence, rather than a performance study.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is what can be inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| The software successfully completes integration/verification testing. | "The iConnection system will successfully complete integration testing/verification testing prior to Beta validation." (Implied successful completion, but no specific metrics or outcomes provided). |
| The software successfully completes Beta testing/validation. | "Software Beta testing/validation will be successfully completed prior to release." (Implied successful completion, but no specific metrics or outcomes provided). |
| The device is substantially equivalent to predicate devices. | "The iConnection system is substantially equivalent to the referenced predicate devices." |
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 for the test set: Not specified.
- Data provenance: Not specified. The document only mentions that the software processes images from various imaging devices (CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF).
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)
- Not specified. The document does not describe a method for establishing ground truth using experts. For the Pet Visualization feature, it states, "the clinician retains the ultimate responsibility for making pertinent diagnosis based on their standard procedures, including visual comparison of separate images," implying human expert interpretation remains central, but this isn't a method for establishing ground truth for a study.
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
- No MRMC comparative effectiveness study is described in the provided text. The document refers to "collaboration mode" as a feature that "allows multiple users to collaboratively interact with iConnection system features and tools," but this is a description of a feature, not a study evaluating human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone performance study for the algorithm without human-in-the-loop is described. The device is described as an "Image Processing Software" that "aids clinicians" and for which "the clinician retains the ultimate responsibility for making pertinent diagnosis."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified.
8. The sample size for the training set
- Not specified. The document mentions the software was "designed, developed, tested, and validated according to written procedures," but does not detail the training set or its size.
9. How the ground truth for the training set was established
- Not specified.
§ 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).