K Number
K203142
Device Name
Veuron-Brain-pAb
Manufacturer
Date Cleared
2021-01-15

(87 days)

Product Code
Regulation Number
892.2050
Panel
RA
Reference & Predicate Devices
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Veuron-Brain-pAb is a software for the registration, fusion, display and analysis of medical images from multiple modalities including MRI and PET. The software aids clinician in the assessment and quantification of pathologies from PET Amyloid scans of the human brain. It enables automatic analysis and visualization of amyloid protein concentration through the calculation of standard uptake volume ratios (SUVR) within target regions of interest and comparison to those within the reference regions. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radio-tracer and disease combinations.

Device Description

The Veuron-Brain-pAb is stand-alone software to automatically calculate the "Standardized Uptake Value Ratio (SUVR)" for quantitative analysis of amyloid PET. The calculated result supports the accuracy of the diagnosis of patients' dementia for the medical professional. It also helps with accurate visual interpretation through visualization functions. Various amyloid PET images can be processed by providing a variety of options for users to choose in the image process.

AI/ML Overview

The provided Presubmission document does not contain the detailed acceptance criteria and study results for the Veuron-Brain-pAb device's performance in the quantitative analysis of amyloid PET scans. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, design features, and general technological characteristics.

However, based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states "Bench testing is done to show that the system is suitable for its intended use and that the measurement tool performance meets its pre-defined requirements," and that "This did not reveal any issues with the system, demonstrating that the performance of Veuron-Brain-pAb is as safe and effective as its predicate devices." However, specific quantitative acceptance criteria (e.g., accuracy, precision, correlation with ground truth for SUVR values) and the actual numerical performance results against these criteria are not reported.

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

This information is not provided in the document. The document mentions "non-clinical study performance" and "bench testing" but does not specify the sample size of the test set used or the provenance (country of origin, retrospective/prospective) of the data.

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

This information is not provided in the document. The document does not describe how ground truth was established for any performance testing.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the document. There is no mention of expert adjudication for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not provided in the document. The document focuses on standalone device performance and substantial equivalence to predicate devices, not on comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the document implies that standalone performance testing was conducted. It states, "The Veuron-Brain-pAb is stand-alone software to automatically calculate the 'Standardized Uptake Value Ratio (SUVR)' for quantitative analysis of amyloid PET." The "non-clinical study performance" and "bench testing" described would likely refer to the evaluation of this standalone performance. However, specific results beyond the general statement of "no issues" are not presented.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not provided in the document. Given the device calculates SUVR for amyloid PET, the ground truth would typically involve either:

  • Standardized quantitative methods using a reference region for SUVR calculation (which the device aims to automate).
  • Correlation with definitive histopathological findings (e.g., brain biopsy/autopsy) or clinical outcomes for amyloid burden.
  • Concordance with expert readings or a consensus panel on amyloid positivity/negativity.
    The document does not specify which, if any, of these were used as ground truth for testing.

8. The Sample Size for the Training Set

This information is not provided in the document. The document does not discuss the development or training of the algorithm.

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

This information is not provided in the document, as the training set and its ground truth establishment are not discussed.

§ 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).