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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.

• 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.

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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 and SPECT scans 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. 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 3.0 compliant specified organ image studies, utilizing PC hardware.

The V-3D Explorer is a software device for evaluating scanned 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 or MR scan 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. 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 an analysis of the provided text regarding the acceptance criteria and study for the Viatronix V3D Explorer:

Summary of Acceptance Criteria and Reported Device Performance

Study Information:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated as a number of cases or patients. The document vaguely mentions "various patients organs with known abnormalities or status" for non-clinical tests and "Patients' various organs" for clinical tests.
   • Data Provenance: The data used for testing was "Scanned image datasets of various patients organs" and "Patients' scanned organs images." The country of origin is not specified, but it implies retrospective use of existing patient data.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

   • Not specified. The document indicates that "known abnormalities or status" were used, implying a pre-established understanding of the pathologies in the patient data. It doesn't detail how this "known status" was determined for the purpose of the study, nor does it mention a specific number or qualification of experts establishing this ground truth for the test set itself.

3. Adjudication Method for the Test Set:

   • Not explicitly described. The study compares the V3D Explorer against predicate devices, stating that "evaluation results of both predicate device and V3D Explorer device were same and no significant differences were detected." This implies a direct comparison rather than an adjudication process typically used to reconcile expert discrepancies for ground truth.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a formal MRMC comparative effectiveness study is not described. The study performed was a comparison of the device's functionality and output against predicate devices, not an evaluation of human reader performance with and without AI assistance.
   • Effect Size: Not applicable, as no MRMC study was performed.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, the non-clinical and clinical tests described appear to be primarily standalone evaluations of the software's ability to process images and provide measurements and visualizations comparable to predicate devices. While the software is intended for use by radiologists and clinicians, the evaluation itself focuses on the software's output, not on how human users integrate the software's output into their diagnostic process or how their performance changes. The phrasing "evaluated various organs using the predicate device and recorded the results" and "evaluated all Patients' various organs using V3D Explorer application, and recorded the results" suggests an assessment of the device's output rather than human performance.

6. Type of Ground Truth Used:

   • The ground truth referenced for the test set is "known abnormalities or status" within patient organ images. For phantom datasets, the ground truth was "pre-calculated values." This implies a combination of expert consensus/clinical diagnosis (for patient data) and empirical measurements (for phantom data). Pathology or outcomes data are not explicitly mentioned as ground truth sources.

7. Sample Size for the Training Set:

   • Not specified. The document describes the V3D Explorer as "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." It mentions "core software technology" developed in a manner consistent with accepted software development standards and unit/system integration testing. It does not provide details on a specific "training set" in the context of machine learning, as this predates widespread deep learning applications for medical image analysis. The "training" likely refers to standard software development and testing practices rather than machine learning model training.

8. How Ground Truth for the Training Set Was Established:

   • Given that the document describes software developed under standard engineering practices rather than a machine learning model, the concept of a "training set" with ground truth (as understood for AI/ML) is not directly applicable or discussed in the text. The "ground truth" for the software's development likely refers to functional requirements specifications, expected outputs, and successful execution of unit and integration tests against these specifications. For phantom data, "pre-calculated values" would serve as the ground truth.

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