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The Voxar 3D product family is a suite of products that is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpreting DICOM compliant tomographic medical imaging.

The Voxar 3D product family provides several levels of functionality to the user .-

• Basic analysis tools they use on a daily basis, such as 2D review, orthogonal . multi planar reconstructions (mpr's), oblique mpr's, curved / cross - curved MPR's, slab MPR's AveiP, MIP, MinIP, measurements, annotations, reporting, distribution, etc.
• Tools for in depth analysis, such as segmentation, enescopic review, colour VR . slab, 3D volume review, path definition and boundary detection, PET imagery analysis, etc
• Specialist tools and workflow enhancements for specific clinical applications . which provide targeted workflows, custom UI, targeted measurement and reporting functions including colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography), calcium scoring (which is intended for non - invasive identification and quantification of calcifieatherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms), Vessel analysis (which is intended for the qualative and quantative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc

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This device is a Picture Archiving and Communications System (PACS) component. The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive details about de novo studies proving new acceptance criteria.

The document indicates that the Voxar 3D Product Family is intended to "aid them in reading and interpreting DICOM compliant tomographic medical imaging." It lists various functionalities such as 2D review, MPRs, MIP, MinIP, measurements, annotations, reporting, distribution, segmentation, endoscopic review, 3D volume review, and specialist tools for applications like colon screening, calcium scoring, and vessel analysis.

Crucially, the document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This statement implies that the device's acceptance criteria are primarily met by demonstrating its equivalence to existing, legally marketed devices.

Therefore, the provided text does not contain the specific information required to answer your questions regarding acceptance criteria, a study proving those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is typically found in a clinical study report or a more detailed technical report which is not included in this 510(k) clearance letter.

Without a detailed study report describing performance against acceptance criteria, I cannot provide the requested table or answer points 2 through 9. The letter confirms a 510(k) number (K043194) and makes a substantial equivalence determination based on the provided indications for use and a comparison to predicate devices.

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Voxar Calcium Scoring is a PC based software only application intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using IST image data and clinically accepted calcium scoring algorithms. Voxar calcium scoring is intended to be used by radiologists and other clinicians.

PC based software only application

This FDA document is a 510(k) clearance letter for the Voxar Calcium Scoring Product and does not contain the detailed study information required to answer your request. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the following information:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document mentions that the device uses "clinically accepted calcium scoring algorithms" but does not detail the specific performance metrics, study design, or validation data that would demonstrate how the device meets acceptance criteria. To obtain this information, you would typically need to refer to the full 510(k) submission, scientific publications, or product documentation from Voxar, Ltd.

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Voxar Colonscreen is a software application for the display and 3D visualization of medical image data derived from CT and MR scans for the purpose of assisting in patient review and detection of colon polyps, cancers and other lesions by providing display and reporting facilities to enhance workflow. It is intended for use by radiologists, clinicians and referring physicians to process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.

Voxar Colonscreen is a software application for the display and 3D visualization of medical image data derived from CT and MR scans.

I am sorry, but the provided text does not contain the acceptance criteria or the details of a study proving the device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for a device called "Voxar Colonscreen."

This letter primarily focuses on:

• Correction of an earlier letter: Amending the "Indications for Use" from "patient screening" to "patient review" to clarify its scope.
• Substantial Equivalence: Stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
• Regulatory information: Providing guidance on general controls, classification, and other FDA regulations.
• The device's intended use: As a software application for display and 3D visualization of CT/MR data to assist in patient review and detection of colon polyps, cancers, and other lesions by radiologists, clinicians, and referring physicians.

It explicitly does not include:

• Quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets).
• Details of a performance study (sample sizes, data provenance, ground truth establishment methods, expert qualifications, adjudication, MRMC studies, standalone performance, training set details).

Therefore, I cannot fulfill your request as the necessary information is absent from the provided document.

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Plug 'n View 3D is a software application for the display and 3D visualization of medical image data derived from CT and MRI scans. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.

Plug 'n View 3D is a software application for the display and 3D visualization of medical image data derived from CT and MRI scans. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.

The provided 510(k) submission for the "Plug 'n View 3D" device does not contain a study that demonstrates the device meets specific acceptance criteria in the manner typically expected for AI/ML-based medical devices today. This submission, dated November 5, 1999, predates the common practice of extensive clinical validation studies with detailed performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device ("Pro Vision Diagnostic Workstation") based on technical features and intended use. The "acceptance criteria" here are implicitly the feature set and functionality of the predicate device, which the new device aims to match or exceed.

Here's an analysis based on the provided text, addressing the requested information:

1. A table of acceptance criteria and the reported device performance

Since this is a submission based on substantial equivalence to a predicate device rather than performance against pre-defined clinical acceptance criteria, the "acceptance criteria" are the features and capabilities of the predicate device, and the "reported device performance" is a comparison to those features.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission does not mention any specific test set, sample size, or data provenance for a performance study. The evaluation relies on a comparison of technical specifications and features to a predicate device, not on a clinical performance study with patient data.

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 establishment is described, as the submission does not involve a performance study with a test set requiring expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned as there is no described test set or expert review process.

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. The "Plug 'n View 3D" is a 3D visualization and image processing tool, not an AI-assisted diagnostic device, and no MRMC study is mentioned. The submission is from 1999, prior to widespread AI in medical imaging.

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

Not applicable. The device is a user-operated visualization tool; it is not an autonomous algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth is mentioned. The device's "acceptance" is based on functional equivalence to a predicate, not diagnostic accuracy against a ground truth.

8. The sample size for the training set

Not applicable. As this device is a software application for image display and 3D visualization, and not an AI/ML diagnostic algorithm, there is no mention of a training set for machine learning.

9. How the ground truth for the training set was established

Not applicable. There is no training set mentioned.

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