(52 days)
i-Dixel is a software for management of images obtained from x-ray imaging equipment and other imaging modalities. i-Dixel is used for medical and dental image examination and diagnosis. The software is to be operated and used by doctor, dentists and other legally qualified professionals.
i-Dixel is a medical and dental diagnostic application for processing, archiving, and managing diagnostic images from multiple imaging modalities and other patient information. i-Dixel processes acquired 2D/3D images for diagnostic use. Any patient record, name, ID, diagnosis, or image can be retrieved by simply clicking the mouse on the desired item in the easy-to-manage filing system made up of patient folders and their images.
The provided text is a 510(k) summary for the i-Dixel image viewer software. It claims substantial equivalence to a previously cleared device (3DX Integrated Information System, part of K030450). The document does not describe a study to prove the device meets specific acceptance criteria in the way a performance study for a novel diagnostic algorithm would.
Instead, the submission relies on the concept of substantial equivalence to an existing predicate device. This means the manufacturer is asserting that the i-Dixel is so similar to the legally marketed 3DX Integrated Information System that it does not raise new questions of safety and effectiveness, and therefore does not require new clinical performance data to demonstrate its capabilities.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
No direct acceptance criteria or reported performance metrics are provided because this is a substantial equivalence submission for an image viewer software, not a diagnostic algorithm with quantifiable performance targets. The "performance" is implicitly deemed equivalent to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. There is no mention of a test set or data provenance because no explicit performance study was conducted. The equivalence is based on the functional similarity to the predicate device.
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 applicable. No ground truth was established for a test set as no performance study was detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is mentioned.
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
Not applicable. No MRMC study was performed or discussed, as the device is an image viewer and not an AI-powered diagnostic tool in the sense of providing assistance to human readers for interpretation tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The i-Dixel is described as image viewer software, and its "performance" is assessed through its functional equivalence to a predicate image viewer, not as a standalone algorithm with diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth was used as no explicit performance study was conducted.
8. The sample size for the training set
Not applicable. The document does not mention any training of an algorithm or a training set.
9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is mentioned.
Summary of the Device's Claimed "Acceptance" (Substantial Equivalence):
The core of the submission for i-Dixel is the claim of substantial equivalence to the "3DX Integrated Information System," which is incorporated into a legally marketed device, "3D Accu-I-tomo XYZ Slice View Tomograph (K030450)." The document states:
- "i-Dixel is slightly revised version of 3DX Integrated Information System which is incorporated to FDA- cleared device..."
- "...all changes are minor and don't pose any additional safety concerns. Safety charges are min has not changed between these two models and we judge these two software ane substantially equal."
- "Consequently, it is self-explanatorily evident that this i-Dixel is substantially equivalent to 3DX Integrated Information System..."
Therefore, the "acceptance criteria" here are implicitly that the i-Dixel performs its intended functions (processing, archiving, managing diagnostic images, viewing, printing, etc.) in a manner that is functionally equivalent to the predicate device, 3DX Integrated Information System, without introducing new safety or effectiveness concerns. The "study" proving this is essentially the manufacturer's self-assessment and comparison to the predicate device, which the FDA then reviewed to affirm substantial equivalence.
§ 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).