Search Results

The Voxar 3D product family is a suite of products that is intended to provide tools for the reading and review of a DICOM compliant series of medical images which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data.

The Voxar 3D product family provides several levels of functionality:

• Basic analysis tools used on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions . (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, and distribution.
• Tools for in-depth analysis, such as regional segmentation of anatomical structures within the image data. . endoscopic review, color volume rendering of finite thickness data cross-sections, 3D review of data volumes, path definition through vascular and other tubular structures and boundary detection.
• Specialist tools and workflow enhancements for specific clinical applications which provide directed workflows. custom User Interfaces, and special measurement and reporting functions optimized for the specific clinical applications. Specialized clinical applications include:
  • Colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other o lesions using tomographic Colonography),
  • Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic o angiographic studies to evaluate occlusive and aneurismal diseases and the effectiveness of stents and stent grafts)
  • Coronary Artery Analysis (which is intended for the qualitative and quantitative analysis of coronary o arteries to evaluate occlusive and aneurismal disease),
  • Functional Cardiac Analysis (which is intended to evaluate the functional characteristics of the heart), O
  • PET-CT Reading (which is intended for analysis of lesions using FDG imaging from hybrid PET-CT o scanners)

This 510(k) submission (K070831) for the Voxar 3D Enterprise with ColonMetrix and PET/CT Perfusion, a Picture Archiving and Communications System (PACS), does not contain the acceptance criteria or a detailed study proving the device meets acceptance criteria.

The document is a letter from the FDA to BarcoView MIS Edinburgh, confirming that their device is substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory compliance and the device's indications for use.

Therefore, I cannot provide the requested information from the provided text. The document is a regulatory approval letter, not an engineering or clinical study report.

Here's what each requested piece of information would require, and why it's not present in this document:

1. A table of acceptance criteria and the reported device performance: This would typically be found in a verification and validation (V&V) report, a clinical study report, or a comprehensive technical specification. This regulatory letter does not include such details.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information would be specific to the testing performed to demonstrate device performance. It is not included in this FDA approval letter.
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): This is a detail of ground truth establishment for a performance study, which is absent here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Another detail typically found in a study design section, not in a regulatory approval letter.
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: The document mentions "Specialist tools and workflow enhancements for specific clinical applications" including "Colon Screening" and "PET-CT Reading," which might suggest such studies were performed. However, the results, methods, and effect sizes of any MRMC studies are not provided in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Similar to MRMC studies, the details of any standalone performance assessment are not available in this letter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This is study-specific information and is not included.
8. The sample size for the training set: This relates to the development of the device's algorithms, not its regulatory approval based on substantial equivalence. This information is not in the document.
9. How the ground truth for the training set was established: Again, this is a detail of algorithm development, not present in this regulatory letter.

In summary, the provided document is a notification of FDA clearance based on substantial equivalence to a predicate device. It does not contain the detailed technical or clinical study data that would describe acceptance criteria or prove device performance.

Ask a specific question about this device

The Voxar 3D product family is a suite of products that is intended to provide tools for the reading and review of a DICOM compliant series of medical images which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical Imaging professionals to aid in their reading and review of such data.

The Voxar 3D product family provides several levels of functionality:

• Basic analysis tools used on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved MPRs, slab MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, and distribution.
• Tools for in-depth analysis, such as regional segmentation of anatomical structures within the image data, endoscopic review, color volume rendering of finite thickness data cross-sections, 3D review of data volumes, path definition through vescular and other tubular structures, boundary detection, and PET image analysis.
• Specialist tools and workflow enhancements for specific clinical applications which provide directed workflows, custom User Interfaces, and special measurement and reporting functions optimized for the specific clinical applications. Also included are computer-sided detection signithms which are the user on possible structures of interest. Specialized dinical applications include:
  • Colon Screening (which Is intended for the screening of patients for colonic polyps, turnours and other o lesions using tomographic Colonography),
  • Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic o anglographic studies to evaluate occusive and aneurismal diseases and the effectiveness of stents and stent grafts)
  • Coronary analysis (which is Intended for the qualitative and quantitative analysis of coronary 0 arteries to evaluate occlusive and aneurismal disease).
  • Functional cardiac analysis (which is intended to evaluate the functional characteristics of the heart),

Not Found

The provided text is a 510(k) premarket notification acceptance letter for the "Voxar 3D Enterprise with CardiaMetrix" device. It does not present a study with acceptance criteria and device performance results. This document summarizes that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot extract the information required for your request from this document. The information you are asking for, such as acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC study details, would typically be found in a separate study report or a more detailed section of the 510(k) submission, not in the FDA's acceptance letter itself.

The letter explicitly 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 (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... " This indicates that the device's acceptability was based on its similarity to existing devices, rather than on a new clinical study demonstrating specific performance metrics against defined acceptance criteria within this document.

Ask a specific question about this device

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 (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, distribution, etc
• Tools for in-depth analysis, such as segmentation, endoscopic 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 calcified atherosclerotic plaques in the coronary arteries using tornographic medical image data and clinically accepted calcium scoring algorithms), Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Voxar 3D Product Family and does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets those criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices for its intended use, but it does not detail performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment. These details would typically be found in the 510(k) submission itself or in accompanying clinical validation reports, which are not part of this FDA clearance letter.

Therefore, I cannot provide the requested information from the given input.

Ask a specific question about this device