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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.

Device Description

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.

AI/ML Overview

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

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