(57 days)
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This is study-specific information and is not included.
- 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.
- 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.
§ 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).