(268 days)
BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software device is indicated for use to assist the physicians in their review and analysis of the 3-D breast ultrasound images generated by ABVS.
BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software also automatically generates reports to provide the sub-image and location information of markers annotated during the image review.
This document describes the BR-ABVS Viewer 1.0, a standalone software device intended to assist physicians in visualizing and analyzing 3-D breast ultrasound images generated by the Siemens ACUSON S2000 Automated Breast Volume Scanner (ABVS).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a comprehensive table comparing multiple performance metrics. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device (ABVS Workplace, K092067) in terms of image loading and overall functionality.
| Feature / Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| 3-D Image Loading | Ability to accurately load and display 3-D breast ultrasound images. | Demonstrated accurate 3-D image loading during comparison testing with the predicate device. |
| Image Visualization | Ability to visualize 3-D image volumes by axial, sagittal, and coronal planes. | Provides visualization of any orientation of 3-D image (axial, sagittal, coronal) according to anatomical coordinate system. |
| Image Size Accuracy | Accurate representation of image size. | Actual image size obtained by considering spacings of three axes specified in standard DICOM tags. |
| Overall Functionality | Similar intended use, technological characteristics, and major functionality to the predicate. | "The intended use, technological characteristics, and major functionality of BR-ABVS Viewer 1.0 are similar to the predicate device..." |
| Safety and Effectiveness | No new issues of safety or effectiveness introduced compared to the predicate. | "...no new issues of safety or effectiveness are introduced by using this device." "The performance data generated... demonstrates that our software device is as safe and effective, as compared to the predicate." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "An actual clinical image generated by a Siemens ACUSON S2000 Automated Breast Volume Scanner in 2014 was used..." This implies a sample size of one clinical image.
- Data Provenance: The image was "generated by a Siemens ACUSON S2000 Automated Breast Volume Scanner in 2014." The country of origin is not explicitly stated, but the manufacturer (TaiHao Medical Inc.) is based in Taiwan. The image is retrospective as it was generated prior to the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set or their qualifications. The performance study appears to be a technical comparison of image loading and visualization between the subject device and the predicate device, rather than a clinical accuracy study requiring expert human annotation/diagnosis as ground truth.
4. Adjudication Method for the Test Set
Not applicable. There is no indication of multiple readers, consensus, or adjudication in establishing ground truth for the single image used in the comparison. The comparison focused on whether the device could load and display the image as expected, similar to the predicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a technical comparison of image loading and display, using a single image, between the subject device and a predicate device. There is no mention of human readers evaluating performance "with AI vs. without AI assistance."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance testing described is primarily a standalone assessment of the BR-ABVS Viewer 1.0's technical capabilities (image loading, visualization, size accuracy) compared to the predicate device. While the device is intended "to assist the physician," the described study itself evaluates the software's inherent ability to process and display images without explicitly measuring the human-in-the-loop performance or diagnostic accuracy.
7. The Type of Ground Truth Used
The "ground truth" for the described performance study appears to be the expected rendering and technical specifications of the 3-D breast ultrasound image when loaded and displayed. The comparison was against the functionality of a legally marketed predicate device (ABVS Workplace) for properties like 3-D image loading, multi-planar visualization, and accurate image sizing based on DICOM tags. It is not an "expert consensus," "pathology," or "outcomes data" type of ground truth.
8. The Sample Size for the Training Set
The document does not specify a sample size for a training set. This device is described as a "Viewer" and not as an AI/ML-based diagnostic algorithm that requires a training set in the typical sense for learning patterns from data. Its function is to visualize existing 3-D images.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As described in point 8, there is no mention or indication of a training set as would be required for machine learning models. The device's primary function is image visualization based on known technical specifications (e.g., DICOM standards).
§ 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).