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The Viatronix V3D-Cardiac is intended to be used for the display and 2D/3D visualization of medical image data derived from CT of the human heart. The goal of this non-invasive, image analysis software package is to assist physician in diagnosing of cardiovascular disease to include, coronary artery disease, functional problem of left ventricle, myocardium anomaly, other heart diseases, and follow-up for stent/graft placement, bypasses and plaque imaging. The image post-processing tools are applied real time on-line by the physician's interactive demand. There is no image processing stage required prior to the start of the using of the V3D-Cardiac. The Viatronix V3D-Cardiac provides a set of fully or semi-automated tools, including, rib cage removal, initial coronary vessel tree segmentation, selected vessel segmentation, vessel crosssectional size measurements, and left ventricle volume functional parameter computation. The V3D-Cardiac will also provide automated setting and display of conventional cardiac imaging planes based on a single user input: selection of the aorta valve. The automatic 2D/3D view correlation is available for vessel analysis views. User can virtually fly thru the vessel lumen in the endoluminal 3D view. Manual tools for adjusting location of center of mitral valve for left ventricle region segmentation are provided. The V3D-Cardiac is intended for use by radiologist, clinicians and referring physicians to acquire, process, render, measure, evaluate, archive, print and distribute DICOM 3.0 compliant coronary artery, left ventricle and other heart anatomy images, utilizing PC hardware.

The Viatronix V3D-Cardiac is a software device for evaluating scanned images of heart. It is designed to aid the physician in analyzing the heart anatomy and detecting anomaly based on images from a CT scan. The heart anatomy includes coronary arteries, cardiac chambers, aorta root, cardiac valve, myocardium, and other parts of the heart. The goal is to simplify the physician's work as much as possible by providing fully or semi-automated tools for segmenting and measuring coronary artery and left ventricle and displaying reformatted images for visualizing complicated heart anatomy. It is an additional image processing option specific to heart imaging procedure added to our V3D visualization system product line, which pre-market clearance was granted by the FDA vide K002780, K013146, K020658, K022789, K032483, K033361, and K040126. It is a general software module, designed for use as a part of our V3D visualization system core technology. The V3D visualization system consists of V3D processor and V3D viewer in multiple computer configuration or V3D processor and V3D viewer in a stand alone one computer configuration. Upon receipt of contrast enhanced, multi-slice CT scan images of human heart in a DICOM format, the V3D processor converts the DICOM image data into an internally recognized volume data format using our core software technology. If there are more than one phase images available, the V3D-processor shall automatically extract each phase image into a separate volume and label the phase percentage information based on the header information from DICOM images. The V3D-Cardiac is an organ specific V3D viewer application. The V3D-Cardiac provides interactive orthogonal and multi-planar reformatted 2D and 3D images. User can evaluate those images for normality or malformation in specified part of heart obtained from scanned CT images.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Viatronix V3D-Cardiac, revision 1.0 device:

No specific acceptance criteria or detailed study results are explicitly stated in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting pre-defined performance metrics. The "acceptance criteria" can be inferred as showing that "evaluation results of both predicate device and V3D-Cardiac were same and no significant differences were detected in the results of evaluation."

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The text mentions "Scanned images datasets of actual patients were selected retrospectively" and "Tests and validations on actual patient data were performed per established protocol." There is no specific number provided for the patient studies used in the comparative evaluation.
• Data Provenance: "Scanned images datasets of actual patients were selected retrospectively." No specific country of origin is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The studies involved comparison by "the physician" (singular, generic) and the output was "evaluated by a trained physician," but no details on their number or specific qualifications (e.g., years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The comparison was made between the predicate device and the V3D-Cardiac results, presumably by a physician. There's no mention of a multi-reader adjudication process (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done?: No, a formal MRMC comparative effectiveness study is not described. The study design directly compares the V3D-Cardiac's output against the predicate device's output on the same datasets, implying a human-in-the-loop comparison for equivalence, not a study to quantify human reader improvement with AI assistance.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable, as this type of MRMC study was not performed. The study aimed at demonstrating equivalence to a predicate device's functionality, not an enhancement to human performance.

6. Standalone Performance Study (Algorithm Only)

• Was it done?: Yes, in a sense. The comparison was described as: "Same image series were loaded into the Viatronix V3D-Cardiac application and the results of evaluation and quantification of coronary arteries and ejection fraction for left ventricle were recorded." This was then compared to the predicate device's recorded results. While "human-in-the-loop" is mentioned for using the V3D-Cardiac ("The image post-processing tools are applied real time on-line by the physician's interactive demand"), the evaluation of the results against the predicate device can be considered showcasing the algorithm's performance indirectly, as it's the output of the algorithm that's being compared. However, it's not a standalone performance measured against a true "ground truth" derived independently of a device, but rather against another device's output. The internal validation against V3D-Vascular for vessel measurements could also be considered an algorithm-to-algorithm comparison (standalone).

7. Type of Ground Truth Used

• Type of Ground Truth: The primary "ground truth" for the main equivalence study was implicitly the output/evaluation from the predicate device (GE Medical System, CardIQ Xpress, revision 6.12.3). The study compared the V3D-Cardiac's evaluation results to those obtained from the predicate device.
  • For internal validation of vessel measurements, the "ground truth" was the measurements created from V3D-Vascular, revision 2.0.
  • No independent "gold standard" like pathology or long-term outcomes data is mentioned as a ground truth source.

8. Sample Size for the Training Set

• Sample Size: Not provided. The document highlights software development processes consistent with standards, suggesting testing and validation, but does not detail the size or nature of data used for training any automated components (e.g., segmentation models). Since the device was cleared in 2008, it's less likely to rely on deep learning models that require very large "training sets" in the modern sense.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not provided. Given the nature of medical imaging software at the time of this submission (2008), automated components would likely use rule-based algorithms or traditional image processing techniques rather than machine learning requiring labeled training data. If any "training" data (e.g., for algorithm tuning) was used, the method for establishing its ground truth is not described.

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The Viatronix V3D Colon is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT and MR scans, for the purpose of patient screening for detection of colon cancers, polyps, masses, and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine views. It generates a centerline for guided interactive navigation and fly through of the entire colon, and also includes a reporting facility to enhance workflow for patient screening. It is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive print and distribute colon image studies utilizing PC hardware.

The Viatronix V3D Colon contains all of the required hardware and software components to provide interactive 3D and 2D views of diagnostic CT and MR scan images of the colon. The views include both inner and outer surface 3D volume rendered images as well as orthogonal and multiplaner reformatted 2D images. This ability to view the dataset in different perspectives from which it was acquired is performed by first transferring DICOM images from the MR or CT scanners to the Viatronix V3D Colon, which automatically identifies regions of interest and displays thesc regions to the user in the above mentioned views. The user can then navigate freely within the dataset/region of interest or follow automatically computed paths to fly through the colon or around the outside of the colon structure. Measurements of the size of colon polyps, masses or lesion can be made for patient screening and for planning treatment.

Here's a breakdown of the acceptance criteria and study information for the Viatronix V3D Colon, revision 1.3, based on the provided document:

Acceptance Criteria and Device Performance

Note on Acceptance Criteria: The document primarily lists "goals of clinical testing" rather than explicit numerical acceptance criteria for all aspects. For sensitivity and specificity, the reported values can be considered the demonstrated performance against assumed implicit acceptance thresholds for a diagnostic tool in this context.

Study Details

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

• Sample Size: A total of 1233 asymptomatic adults.
• Data Provenance: US Government's Department of Defense Medical Centers (United States). The study was prospective, as it involved subjects undergoing both virtual colonoscopy and optical colonoscopy on the same day.

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

• The document implies that the "Results" section of the major clinical study (8.1) references data where Optical Colonoscopy (OC) served as a comparator for sensitivity and specificity. However, it does not explicitly state the number of experts who established the ground truth from OC, or their qualifications.
• For the "Initial Clinical tests" (8.2), a single radiologist reviewed the clinical data.
  • Qualifications of Radiologist (8.2): Experienced with predicate devices.

3. Adjudication Method for the Test Set:

• For the main clinical study (8.1), the document mentions a comparison with optical colonoscopy. One paragraph states: "Two polyps were malignant; both were detected on VC and one was missed on OC before the results on VC were revealed." This implies a potential sequential or blinded review process where OC findings were known post-VC review, but a formal adjudication method (like 2+1) is not explicitly detailed.
• For the "Initial Clinical tests" (8.2), the review was performed by a single radiologist, suggesting no formal adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• No, a formal MRMC comparative effectiveness study aiming to measure the effect size of human readers with vs. without AI assistance is not described.
• The main clinical study (8.1) compares the device's performance (VC) directly against Optical Colonoscopy (OC) in terms of sensitivity and specificity, effectively comparing the AI-assisted diagnostic pipeline (VC reviewed by an unnamed number of readers) to the gold standard (OC). It does not isolate the improvement from AI assistance to a human reader.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No, the studies described do not appear to be standalone algorithm-only performance evaluations.
• The device is a "system for the display and visualization" intended for use by "Radiologists, Clinicians and referring Physicians." The clinical study evaluated "Virtual Colonoscopy (VC) ... by patient," which implicitly involves human interpretation of the V3D Colon output. The "Initial Clinical tests" section explicitly states that a radiologist reviewed the rendering.

6. The Type of Ground Truth Used:

• For the main clinical study (8.1): Optical Colonoscopy (OC) findings were used as the primary ground truth. This is a form of clinical/procedural ground truth.
• For the non-clinical tests (7): Phantoms with structures of known size and distance were used. This is a form of physical phantom ground truth.

7. The Sample Size for the Training Set:

• The document does not specify a sample size for the training set. It discusses the development process ("developed in a manner consistent with accepted standards for software development, including test protocols") and testing, but not the data used to train the AI/algorithm component of the system.

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

• The document does not provide information on how ground truth was established for any training set, as a training set is not explicitly discussed.

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The Viatronix V3D Vascular is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI scans or 3D X-Ray angiography of the selected human vessels, e.g., the coronary arteries, the carotid arteries, the peripheral arteries, the aorta, arteries of the brain, and any opacified veins. The goal of this device is to automate routine inspection of human vessels to detect stenosis, plaque, bulge, aneurismal sac and dissection in the vessel. It also supports the interactive segmentation of any vessel by hiding certain parts of the data set from display for critical evaluation of selected part(s) of vessel. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, measure, evaluate, archive, print and distribute DICOM 3.0 compliant vessel image studies, utilizing PC hardware.

The V-3D Vascular is a software device for evaluating scanned images of selected vessels. The V3D Vascular module is designed to aid the physician in analyzing the vascular system based on images from a CT or MR scan or X-Ray angiography. The vessels include the coronary arteries, the carotid arteries, the peripheral arteries, the aorta, arteries of the brain, and any opacified veins. The goal is to automate routine inspection of the vessels as much as possible. 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 multislice CT or MR scan image for any selected vessel 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 vessels obtained from scanned images using the following methods:
a ) The V3D Vascular shall initially segment out all the possible vessels of interest in the dataset.
b } The V3D Vascular shall provide a selection view that allows selection of the vessels that the user wishes to visualize. Any vessels not desired or not actually vessels will then be hidden from view unless the user goes back to the view to re-select.
When examining a vessel the module shall be used to aid in the following ways: c ) The V3D Vascular shall be used to aid the physician in the determination and localization of stenosis in the vessels.
d ) The V3D Vascular shall be used to help determine the type of plaque in the vessels. e ) The V3D Vascular shall be used to determine the presence or absence of a bulge or an aneurysmal sac in the wall of the vessel.
f ) The V3D Vascular shall be used to determine the presence or absence of a dissection. A dissection is a break in the interior lining of the vessel - the intima - that leads to pooled fluid between the intima and media that form the wall of the vessel. The intended user can use the software device to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant images of any vessel, utilizing PC hardware.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The device, Viatronix V3D Vascular, Revision 1.0, is a software system intended to aid physicians in analyzing scanned images of vessels. Its acceptance criteria are implicitly defined by its ability to perform the same functions as the predicate devices, particularly in measurement and evaluation of vessel abnormalities, and by demonstrating substantial equivalence.

Table 1: Acceptance Criteria (as inferred by comparison to predicate devices) and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a number. The document mentions "Scanned image datasets of various patients vessels with known abnormalities or status" were used. For clinical tests, it mentions "Patients' various vessels."
   • Data Provenance: The data consisted of "patients' vessels" with "known abnormalities or status." It is implied to be retrospective, as the data already existed with known statuses. The country of origin is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified.
   • Qualifications: Not specified. The summary only mentions "known abnormalities or status," implying these were clinically determined.

3. Adjudication method for the test set:

   • Not specified. The ground truth seems to be based on pre-existing clinical diagnoses or "known abnormalities or status" rather than an active adjudication process for the study.

4. 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 was done to assess human reader improvement with AI assistance. The study focused on comparing the device's measurements and evaluations directly against a predicate device using the same scanned images. The device is an "aid" to the physician, but its comparative effectiveness in improving human reader performance was not evaluated in this submission.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance assessment was effectively done. The "non-clinical tests" involved testing "software functionalities in accordance with a test protocol" using datasets with "known abnormalities or status." The "clinical tests" separately loaded the same scanned images into the device and recorded results for evaluation and quantification. The comparison was primarily between the V3D Vascular device's outputs and the predicate device's outputs, acting as a standalone performance check against an established device.

6. The type of ground truth used:

   • Clinical/Expert Diagnosis: The ground truth for the test datasets was based on "known abnormalities or status" of the vessels. This implies previously established clinical diagnoses or expert assessments. For non-clinical tests, "phantom datasets" were used, for which the "level of accuracy... correlates perfectly with pre-calculated values," indicating a synthetic ground truth for those specific tests.

7. The sample size for the training set:

   • Not specified. The document primarily discusses testing and validation; there is no mention of a distinct "training set" or its size.

8. How the ground truth for the training set was established:

   • Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not provided. The development process mentions "both unit and system integration testing protocols," but does not detail how data for initial algorithm development or parameter tuning (if any) was handled regarding ground truth.

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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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The Viatronix V3D Colon is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT and MR scans, for the purpose of screening a colon to detect polyps, masses, cancers and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine views. It generates a centerline for guided interactive navigation and fly through of the entire colon, and also includes a reporting facility to enhance workflow for screening a colon. It is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive, print and distribute colon image studies utilizing PC hardware.

The Viatronix V3D Colon contains all of the required hardware and software components to provide interactive 3D and 2D views of diagnostic CT and MR scan images of the colon. The views include both inner and outer surface 3D volume rendered images as well as orthogonal and multiplaner reformatted 2D images. This ability to view the dataset in different perspectives from which it was acquired is performed by first transferring DICOM images from the MR or CT scanners to the Viatronix V3D Colon, which automatically identifies regions of interest and displays these regions to the user in the above mentioned views. The user can then navigate freely within the dataset/region of interest or follow automatically computed paths to fly through the colon or around the outside of the colon structure. Measurements of the size of colon polyps, masses or lesions can be made for patient screening and for planning treatment.

Here's a summary of the acceptance criteria and study information for the Viatronix V3D Colon, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria with specific numerical targets. Instead, the acceptance criteria are implicitly defined by the goals of the clinical testing, focusing on functionality, accuracy, and substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Non-clinical (Phantom) Test Set:

  • Sample Size: Not explicitly stated, but implies multiple "structures of a known size and distance" inserted into the phantom.
  • Data Provenance: N/A (phantom data)

• Clinical (Human) Test Set:

  • Sample Size: Not explicitly stated, described as "broad sampling of input data" and "each patient was assessed."
  • Data Provenance: Prospective (clinical studies were performed under IRB overview, which included Patient Consent Forms). Country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Non-clinical (Phantom) Test Set:

  • Number of Experts: One independent reviewer.
  • Qualifications: "An independent reviewer." Specific qualifications (e.g., years of experience, medical specialty) are not detailed.

• Clinical (Human) Test Set:

  • Number of Experts: One radiologist.
  • Qualifications: "A radiologist who determined that the rendering was accurate and medically useful. The radiologist was experienced with the predicate devices." Specific years of experience or subspecialty are not detailed.

4. Adjudication Method for the Test Set

• For the non-clinical phantom study, the "independent reviewer" compared test results with the actual phantom to assess accuracy. This implies direct comparison rather than a formal adjudication process involving multiple experts for disagreement resolution.
• For the clinical study, a single radiologist made the determination of accuracy and medical usefulness. There is no mention of a multi-reader adjudication method (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance was not explicitly described. The clinical evaluation involved a single radiologist assessing the device's output and comparing it qualitatively to optical endoscopy and predicate devices.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the testing described appears to be a standalone evaluation of the device. The system automatically identifies regions of interest, displays them, generates centerlines for navigation, and provides measurement tools. The radiologist then reviews and uses this output. The evaluation focuses on the device's ability to render images, permit navigation, and make accurate measurements, which are functions of the algorithm without continuous human-in-the-loop intervention for its primary output generation. The radiologist's role was to review and determine accuracy and usefulness, implying the device produced results first.

7. The Type of Ground Truth Used

• Non-clinical (Phantom): Physical ground truth – "structures of a known size and distance" inserted into the phantom, against which the device's measurements were compared.
• Clinical (Human): Relative ground truth –
  • Qualitative judgment by a radiologist.
  • Comparison with "optical endoscopy" for visualization capabilities.
  • Comparison to the performance of predicate devices.
  • The "System Clinical Test Results (Visualization of Polyps)" suggests comparison to pathology or clinical findings might have been part of the evaluation, but the direct method for establishing truth related to specific lesions is not fully detailed beyond "qualitative judgment."

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. The focus is on the evaluation of the finalized device.

9. How the Ground Truth for the Training Set was Established

Since no training set information is provided, how its ground truth was established is also not present in the document.

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The Viatronix V3D Calcium Scoring System is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis.

The V-3D Calcium Scoring System for Coronary Artery Calcification Scoring 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. The V-3D Calcium Scoring is an anatomy specific 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. Upon receipt of a multi-slice CT scanner image for coronary arteries through DICOM, 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 2D and 3D views from the V-3D viewer and determines the density and location of calcium deposits within the coronary arteries and also scores measurements of calcium deposits. The calcium score provides a quantitative evaluation of the extent of plaque accumulation in the coronary arteries.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

• t-tests concluded that the difference between the means of the V3D Calcium Scoring application and the predicate device was "zero or insignificant with a 99% level of confidence" for both volumetric and Agatston scores.
• F-tests concluded that the two sets of scores did "not differ in variability with a 99% level of confidence" for both volumetric and Agatston scores.
• For simulated phantom datasets, the output results "correlated perfectly to the pre-calculated score values." |
  | Reliability | "The product has shown itself to be reliable, easy to use and capable of calculating useful Calcium Score values." |
  | Usability | "The product has shown itself to be reliable, easy to use and capable of calculating useful Calcium Score values." |
  | Ability to Review and Analyze CT Images for Cardiac Calcium Scoring | Demonstrated through statistical equivalence to the predicate device in calculating calcium scores, which is a core function for reviewing and analyzing images for this purpose. |

Explanation of "Implicit" Acceptance Criteria: The document does not explicitly list numerical acceptance criteria (e.g., "accuracy must be >95%"). Instead, the primary acceptance criterion is substantial equivalence to existing predicate devices. This means the Viatronix V3D Calcium Scoring System must perform comparably to the predicate devices in terms of its ability to calculate calcium scores. The statistical tests performed (t-test and F-test) are designed to demonstrate this equivalence.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: The document mentions "Patients' Calcium Scoring Cases" were used for the clinical evaluation, but it does not specify the number of cases used.
• Data Provenance: The data comes from "Patients' Calcium Scoring Cases." It does not explicitly state the country of origin. The study appears to be retrospective, as "Same Cases were loaded into the Viatronix V3D Calcium Scoring application" after being evaluated with the predicate device.

3. Number of Experts and Qualifications for Ground Truth:

• The document does not explicitly state the number of experts used to establish the ground truth for the test set.
• It implies that the "predicate device" was used to establish the initial scores, which were then compared to the scores from the Viatronix device. Therefore, the "ground truth" for the comparison was based on the performance of an already cleared device, not human experts providing a "true" score independently. This is a common approach for demonstrating substantial equivalence.

4. Adjudication Method:

• None directly stated. The "ground truth" for comparison was generated by the predicate device. The study design involved comparing the new device's output to the output of the predicate device, not adjudicating discrepancies between multiple human readers or between human and AI.

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

• No, an MRMC comparative effectiveness study was not done. The study's focus was on the equivalence of the device's numerical calculation output compared to a predicate device, not on how the device assists human readers or improves their performance.

6. Standalone Performance Study:

• Yes, a standalone performance study was done. The entire clinical study described involved the algorithm (Viatronix V3D Calcium Scoring application) calculating scores, which were then compared to scores calculated by the predicate device. There is no mention of human interaction during the Viatronix device's scoring process for the purpose of the study.
• Additionally, simulated "phantom" datasets with "known values" were used, where the device's output "correlated perfectly to the pre-calculated score values." This demonstrates standalone performance against an ideal, theoretical ground truth.

7. Type of Ground Truth Used:

• For the clinical evaluation, the ground truth was essentially the scores generated by the predicate device. This is a form of "reference standard" comparison to an already accepted technology.
• For the non-clinical tests, the ground truth was pre-calculated theoretical values derived from "known values" in simulated phantom datasets.

8. Sample Size for the Training Set:

• The document does not specify the sample size for the training set. It only mentions development and testing.

9. How Ground Truth for Training Set Was Established:

• The document does not provide details on how ground truth was established for any training data. It primarily focuses on the validation of the final product against predicate devices and simulated data.

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