(74 days)
iConnection 3D is a software application intended for integrated processing and distribution of 2D and 3D digitized data derived from CT and MRI (and others) scans for use by radiologists, clinicians, and other professionals to acquire, process, render, review, store, print, and distribute DICOM 3.0 compliant images utilizing standard PC hardware with MS 98, NT, or MS 2000 operating systems. CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
iConnection 3D is a picture archiving and communications system as described in 21 CFR 892.2050.
This 510(k) premarket notification for iConnection 3D does not include information about acceptance criteria or a study proving the device meets them.
The device, "iConnection 3D," is a Picture Archiving and Communication System (PACS) software application. The summary explicitly states:
1. A table of acceptance criteria and the reported device performance:
Not provided. The document states "Performance Data: None required."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not provided. No test set is mentioned because performance data was not required.
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 provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not provided.
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 study was done or reported. This product is a PACS system, not an AI-assisted diagnostic tool in the sense of recent AI applications.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/Not done. The device is a PACS system for processing and viewing images, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not provided.
8. The sample size for the training set:
Not provided.
9. How the ground truth for the training set was established:
Not provided.
Conclusion from the 510(k) Summary:
The claim of substantial equivalence for iConnection 3D is based solely on "comparisons of intended use(s) and specifications/functions of the cited predicate devices" (Voxar Limited PLUG 'N VIEW 3D and Applicable Medical Imaging B.V. devices). No performance data or clinical studies were presented to demonstrate the device's efficacy or meet specific acceptance criteria. This approach was acceptable by the FDA for this particular type of device (a PACS system) in 2001.
§ 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).