(10 days)
The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET, SPECT scans and X-Ray of the human body including any organ. The volume, linear and angular measurement functions are intended for the evaluation and quantification of turnor or selected organ volume/linear measurements, angular location/ displacement, study/ analysis and evaluation of both hard and soft tissues as well as other internal organ structures for polyp, lesion, mass, implants, fracture, aneurysms, stenoses etc or evaluation of any abnormality / malformation in specified organs obtained from scanning and/or X-Ray. It also supports the interactive segmentation of any organ by removing certain structure(s) from display for critical evaluation of selected part(s) of organ. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, evaluate, archive, print and distribute DICOM compliant specified organ image studies, utilizing PC hardware.
The V-3D Explorer is a software device for evaluating CT/MRI scanned and X-Ray images of selected human organ. It is an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780, dated November 17, 2000. It is a general software module, designed for use as a part of our V-3D visualization system core technology. The system consists of a V-3D processor and a V-3D viewer in two computer configuration or V-3D processor and V3D viewer in a stand alone one computer configuration. Upon receipt of a multi-slice CT / MR scan image or X-Ray image for any selected organ in a DICOM format, the V-3D processor converts the DICOM image data into an internally recognized volume data format using our core software technology. The V-3D viewer provides interactive orthogonal and multiplanar reformatted 2D and 3D images from the V-3D processor and user can evaluate these images for any abnormality or malformation in specified organs obtained from scanned images or X-Ray images. The volume, linear and angular measurement features provided in the software for the evaluation and quantification of organ volume, linear measurements, angular location/displacement for hard and soft tissues as well as internal organ structures for polyp, lesion, mass, tumor, implants, fracture, aneurysms, stenoses etc. The software also supports interactive segmentation of any organ from removing certain structure from display for critical evaluation of selected part of organ. The intended user can use the software device to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant images of any organ, utilizing PC hardware.
Here's a breakdown of the acceptance criteria and the study details for the Viatronix V3D Explorer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document focuses on substantial equivalence rather than explicit quantitative acceptance criteria for device performance. The primary "criterion" is that the V3D Explorer performs similarly to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Qualitative Equivalence: |
- Display and 2D/3D visualization of medical image data (CT, MRI, PET, SPECT, X-Ray)
- Evaluation and quantification of tumor/organ volume, linear measurements, angular location/displacement
- Study/analysis of hard/soft tissues, internal organ structures (polyp, lesion, mass, implants, fracture, aneurysms, stenoses)
- Evaluation of abnormalities/malformations
- Interactive segmentation of organs
- Acquisition, processing, rendering, evaluation, archiving, printing, distribution of DICOM compliant images | - V3D Explorer provided interactive orthogonal and multiplanar reformatted 2D and 3D images from datasets to detect and evaluate known abnormalities or status of organs.
- Volume, linear and angular measurement features were used to evaluate and quantify abnormalities or status of internal organ structures.
- Evaluation results of both predicate device and V3D Explorer device were same, and no significant differences were detected in the results of evaluation.
- DICOM compliant X-Ray images were correctly processed and converted, allowing for accurate display and evaluation.
- Phantom data showed measurements are accurate.
- Concluded the V3D Explorer is substantially equivalent to predicate devices in its ability to review, analyze, and evaluate images. |
| Accuracy of Measurements: - Volume, linear, and angular measurements | - Phantom data showed that the measurements are accurate and the V3D Explorer is evaluated to be safe and effective. |
| Reliability and Ease of Use: - Consistent operation and user-friendliness | - The product has shown itself to be reliable, easy to use and capable of evaluating DICOM 3.0 compliant scanned images or X-Ray images of any human organs. |
| Software Development Standards: - Developed in accordance with accepted standards | - The V3D Explorer Module has been developed in a manner consistent with accepted standards for software development, including both unit and system integration testing protocols. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Scanned image or X-Ray datasets of various patients organs" and "Patients' various organs" were used. The exact number of patients or cases is not specified.
- Data Provenance: The data came from "various patients organs with known abnormalities or status." It is not explicitly stated whether the data was retrospective or prospective, or the country of origin. However, the use of "known abnormalities or status" suggests that these were existing clinical cases, implying a retrospective nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts or their qualifications involved in establishing the ground truth for the test set. It mentions "known abnormalities or status," which implies that a previous clinical assessment (likely by medical professionals) already determined these conditions.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing ground truth from multiple experts. The ground truth appears to be based on pre-existing "known abnormalities or status".
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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study directly compared the V3D Explorer's output against predicate devices and pre-calculated phantom values, not against human reader performance with or without the device. The V3D Explorer is presented as an image processing and visualization tool to be used by radiologists, clinicians, and referring physicians, not as an AI-assisted diagnostic aid that directly improves human reader performance in a quantitative sense as might be assessed in an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone evaluation was implicitly done. The software's functionalities, measurements, and processing capabilities were tested independently (or in comparison to predicate devices) to verify its performance. The phrase "Evaluation results of both predicate device and V3D Explorer device were same and no significant differences were detected" suggests a direct comparison of the software outputs.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- "Known abnormalities or status": For patient data, the ground truth was based on pre-existing clinical knowledge of the patient's condition. The specific method (e.g., pathology reports, follow-up, expert consensus) is not detailed.
- "Pre-calculated values": For phantom datasets, the ground truth was established by known, pre-calculated values for the phantom's characteristics.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This device is described as a software tool for image processing and visualization, not an AI/ML diagnostic algorithm that typically requires a dedicated training set. The software development included "unit and system integration testing protocols," which would involve software validation on various datasets, but these are not referred to as a "training set" in the modern AI sense.
9. How the Ground Truth for the Training Set Was Established
As no training set (in the AI/ML sense) is mentioned, there is no information on how its ground truth was established. The testing described is more akin to software validation against known outcomes or established standards.
§ 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).