Search Results
Found 2 results
510(k) Data Aggregation
(43 days)
The Breast Volume Navigator (BVN) is an add-on accessory for existing ultrasound imaging systems and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2-dimensional image slices throughout a volume of interest. The BVN is intended to acquire, analyze, store and retrieve digital ultrases for computerized 3-dimensional image processing.
The BVN is intended to assist health care providers trained in breast ultrasound with tools for electromagnetic tracking of instruments with respect of breast ultrasound images generated from FDA cleared hand-held ultrasound devices. The BVN is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with a linear array transducer.
The BVN is indicated for use as an adjunct to hand-held breast ultrasound to assist the health care providers trained in breast ultrasound in their scanning process. The scanning paths are displayed on a route map and provide quality control of scanning to provide an overall observation of scanning process.
The BVN Software Application is intended as a standalone software device installed on a windows-based computer to assist physicians with manipulation and analysis tools in reviewing breast ultrasound images. Images and data are previously recorded from various imaging systems and other sources such as calibrated spatial positioning devices. The BVN Software Application provides the capability to visualize ultrasound images along with the scanning paths and position information of the probe that is stored in the DICOM file in advance.
The BVN will allow exporting to any third-party application that has the appropriate level of DICOM compliance. The BVN is intended as a general-purpose digital 3D breast ultrasound image processing tool for radiology and surgery.
The device is not intended to be used in the environment of strong magnetic fields, such as in Magnetic Resonance Imaging (MRI) room.
The device is not intended to be used as a replacement for screening mammography.
The Breast Volume Navigator (BVN™) Model G-2000, hereinafter maybe referred to as the BVN™ G-2000 System or the BVN™ System, comprises hardware components and a software element, including the following components: a magnetic position tracking device, sensor attaching pieces used to attach magnetic sensors to the skin and ultrasound probe, a central control unit computer, and software for controlling the system, collecting, and processing ultrasound images and positional data, and performing automated annotations.
The BVN™ System has a touch-screen user interface and push-button for power on the system.
The Use Interface (touchscreen display and central control unit computer) are placed on a medical grade cart that can be positioned next to a standard adjustable examination table for ease of use and ergonomic adaptation.
The BVN™ System has a USB port available for transferring files via USB Memory Stick.
The BVN™ System has an Ethernet port for connection to a PACS system, using DICOM.
The BVN™ System has a VGA/DVI Input Ports for capturing images from an ultrasound imaging scanner.
The BVN™ System receives ultrasound DICOM images from the US machine via the network connection and telemetry data from a position tracking system. The BVN™ automatically detects when the image is being frozen on the US machine and takes a snapshot of the telemetry data at that time. Later, when the BVN™ receives the DICOM image, it associates the telemetry data to the image from the time when the image was frozen on the US machine.
A Completeness-of-Scan Assessment ensures that all breast tissue has been sufficiently covered, the BVN™ System will achieve this by tracking the real-time position of the probe relative to the breast and chest wall to ensure the entire breast volume has been covered with sufficient detail to allow the detection of sub centimeter lesions. As the probe is swept over the breast region, the technician will be provided a completeness map highlighting the portions of the breast that have not been sufficiently scanned. The BVN™ System will provide the operator a display of regions with insufficient coverage, prompting the operator to rescan these regions. The BVN™ System can retrieve previous examinations DICOM images allowing the user to enter positional data from another/previous ultrasound examination for follow-up purposes. Any anomalies discovered during the follow-up process can be evaluated using the localization and measurement tools included in the software.
The customer's existing ultrasound probe securely attaches to the BVN™ System probe sensor. During a scan, the operator applies constant pressure to the transducer against the patient's breast tissue and can rotate the transducer (pitch and roll) to accommodate for the physical characteristics of the breast.
Exam data is subsequently reviewed on standard radiological viewing stations.
The provided text describes the acceptance criteria and study results for the MetriTrack Breast Volume Navigator (BVN™) Model G-2000.
Acceptance Criteria and Performance Study Table
| Acceptance Criteria (Performance Metric) | Target/Threshold | Reported Device Performance |
|---|---|---|
| Linear Accuracy and Precision of Distance to Nipple | ≤ 5 mm | Achieved ≤ 5 mm |
| Accuracy and Precision of Clock Face Angle | ≤ 5 degrees | Achieved ≤ 5 degrees |
| Accuracy and Precision of Patient Body Angles | ≤ 5 degrees for Coronal, Transverse, Sagittal planes | Achieved ≤ 5 degrees for all three anatomical planes |
| Accuracy and Precision of Linear Accuracy | ≤ 1 mm at one standard deviation | Achieved ≤ 1 mm at one standard deviation |
| Completeness of Scanning Breast Contour Accuracy | +/- 5 mm maximum positional error in X-Y plane | Accurately captured and represented hand-drawn breast contour with a maximum positional error of +/- 5 mm in the X-Y plane. |
| Overlap between Adjacent Scanning Bands | Discern when overlaps are < set threshold (5-30 mm ± 2 mm) | Able to discern when overlaps of adjacent bands are less than a set threshold within a range of 5 to 30 mm ± 2 mm of overlap. |
| 3D Point Coordinates Velocity | Detect velocities above/below threshold (15-50 mm/s +/- 10% at 1 SD) | Detected 3D Point coordinates of image corners velocity above and below a set threshold within a range of 15 to 50 mm/s +/- 10% at 1 standard deviation. |
Study Details
-
Sample Size and Data Provenance:
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of number of cases or patients from a clinical study. Instead, it refers to "Extensive Performance, Verification and Validation testing" conducted "in-house by trained personnel in a simulated work-environment using phantoms."
- Data Provenance: The testing appears to be conducted in a simulated lab environment ("in-house") using "phantoms." The document does not indicate the country of origin for the data or whether it was retrospective or prospective. It suggests controlled lab studies rather than clinical data.
-
Number of Experts and Qualifications for Ground Truth:
- The document states that the testing was performed "by trained personnel." It does not specify the number of experts or their specific qualifications (e.g., radiologists, years of experience) used to establish ground truth for the test set. Given the phantom-based testing, the "ground truth" would be the known physical properties and measurements of the phantoms.
-
Adjudication Method for the Test Set:
- No information on adjudication methods is provided, as the testing was primarily against known phantom parameters rather than expert readings needing adjudication.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study involving human readers with or without AI assistance is mentioned. The study described focuses solely on the device's measurement accuracy and completeness of scan capabilities using phantoms.
-
Standalone (Algorithm Only) Performance:
- The performance data presented are for the BVN™ System itself, acting as an accessory to existing ultrasound systems, particularly its ability to track position, measure distances/angles, and ensure scan completeness. This can be considered the standalone performance of the device's core functionalities in a controlled setting, but not necessarily a standalone AI algorithm in a diagnostic context, as the device is not making diagnostic interpretations.
-
Type of Ground Truth Used:
- The ground truth was established by the known physical dimensions and properties of the phantoms used for testing. For example, distances, angles, and scan coverage could be precisely controlled and measured on the phantoms.
-
Training Set Sample Size:
- The document does not mention a separate "training set" or "training data" as the device is described as an accessory that performs measurements and tracking, rather than an AI/ML diagnostic algorithm that requires extensive training data. The "acceptance criteria" are based on accuracy against physical measurements, not a trained model's diagnostic output.
-
How Ground Truth for Training Set was Established:
- Not applicable, as no distinct training set for an AI/ML algorithm is described. The device's functionality appears to be based on established engineering and measurement principles applied to physical sensors and software logic, not a learned model from a dataset.
Ask a specific question about this device
(27 days)
The Breast Volume Navigator (BVN) is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The BVN is intended to acquire, and retrieve digital ultrasound images for computerized 3-dimensional image processing.
The BVN will allow exporting to any third party application that has the appropriate level of DICOM compliance.
The BVN is intended as a general purpose digital 3D breast ultrasound image processing tool for radiology and surgery.
The BVN is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer.
The device is not intended to be used as a replacement for screening mammography.
The Breast Volume Navigator (BVN) System comprises hardware components and a software element, including the following components: a magnetic position tracking device, sensor attaching pieces used to attach the magnetic sensors to the skin and ultrasound probe, a central control unit, and software for controlling the system, collecting and processing images and positional data, and performing automated annotation.
The Breast Volume Navigator (BVN) has a touch-screen user interface and a push-button for power on the system. The User Interface can be placed on a stand next to the examination table for ease of use and ergonomic adaptation.
The BVN has a USB port available for transferring data files via USB Memory Stick. The BVN has an Ethernet port for connection to a PACS system, using DICOM. The BVN has a VGA/DVI Input Ports for capturing images from an ultrasound imaging scanner.
The Breast Volume Navigator (BVN) System receives ultrasound DICOM images from the US machine via the network connection and telemetry data from a position tracking system.
The BVN automatically detects when the image is being frozen on the US machine and takes a snapshot of the telemetry data at that time. Later, when the BVN receives the DICOM image, it associates the telemetry data to the image from the time when the image was frozen on the US machine.
The customer's existing ultrasound probe securely attaches to the BVN probe sensor. During a scan, the operator applies constant pressure to the transducer against the patient's breast tissue and can rotate the transducer (pitch and roll) to accommodate for the physical characteristics of the breast.
Exam data is subsequently reviewed on standard radiological viewing stations. Any lesions or anomalies discovered during the review process can be evaluated using the localization and measurement tools included in the software.
The document provides information on the Breast Volume Navigator (BVN), a device intended to assist with 3D breast ultrasound image processing.
Here's an analysis of the acceptance criteria and the study data provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional/Accuracy) | Reported Device Performance |
|---|---|
| Accuracy and Precision of Distance Measurement | 5 mm |
| Accuracy and Precision of Clock Face Angle Measurement | 5 degrees |
| Accuracy of Anatomical Plane Angle Measurement (Coronal, Transverse, Sagittal) | 5 degrees |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Test Set: The document explicitly states "9 test locations in 4 layers" for the design validation tests. This refers to 36 distinct points (9 locations x 4 layers) on a test phantom where measurements were taken.
- Data Provenance: The testing was conducted "in-house by trained personnel in a simulated work-environment using phantoms." This indicates a prospective and controlled laboratory setting using simulated data (phantoms) rather than human patient data. There is no mention of country of origin as it was a simulated environment.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth for the test set. Given that the testing was performed on a phantom in a simulated environment, the "ground truth" for distance and angle measurements would likely be derived from the known physical specifications of the phantom and the calibrated measurement tools used, rather than expert consensus on medical images.
4. Adjudication Method (Test Set)
The document does not specify an adjudication method. Since the testing was conducted on a phantom with known physical properties, the ground truth would be objectively verifiable through the phantom's design and measurement instruments, not through clinical adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or any comparison of human readers with vs. without AI assistance. The study focuses purely on the device's technical performance with phantoms.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was conducted. The "Performance, Verification and Validation testing" and "DESIGN VALIDATION TESTS - NON-CLINICAL TESTING" sections describe tests performed on the device (Breast Volume Navigator system) in a simulated environment using phantoms, without human intervention for interpretation of the results from the device itself. The device is assessed for its ability to accurately measure distances and angles of targets on the phantom.
7. Type of Ground Truth Used (Test Set)
The ground truth used for the test set was based on the known physical dimensions and configurations of a test phantom. This is a form of engineered or objective ground truth, as opposed to expert consensus, pathology, or outcomes data from human subjects.
8. Sample Size for Training Set
The document does not provide any information regarding a training set sample size. The tests described are purely performance verification and validation against design specifications using simulated data, not an AI or machine learning model that would require a training set.
9. How Ground Truth for Training Set Was Established
Since no training set is mentioned or implied by the type of device and testing described, there is no information on how ground truth for a training set was established. The BVN appears to be a hardware/software system for navigation and 3D data acquisition/processing, not a diagnostic AI algorithm that learns from data.
Ask a specific question about this device
Page 1 of 1