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BR-FHUS Navigation 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist physicians with tools for electromagnetic tracking of instruments in respect of breast ultrasound images generated from FDA cleared handheld ultrasound devices. The device is not intended to be used in the environment of strong magnetic or electromagnetic fields, such as in Magnetic Resonance Imaging (MRI) room. BR-FHUS Navigation 1.0 is indicated for use as an adjunct to handheld breast ultrasound to assist the physicians 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.

BR-FHUS Navigation 1.0 is a standalone software device installed on a standalone windows-based computer. It requires an off-the-shelf PC computer, computer user interface (keyboard, mouse, display), off-the-shelf image capture device (PCI frame grabber card or USB frame grabber device), and an off-the-shelf 3D electromagnetic tracking system (Ascension Technologies). The system includes software for Position Sensor Monitoring, Image presentation and recording, and user interface, and hardware including a Position Sensor Clip (electromagnetic), Sensor Transmitter, and Control Computer.

The provided text describes the BR-FHUS Navigation 1.0 device and its substantial equivalence to a predicate device, the Tractus TissueMapper Image Recording System. However, the document does not contain detailed acceptance criteria or a specific study proving the device meets quantitative acceptance criteria beyond a general statement of "in specification."

Here's a breakdown of the information that can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for performance metrics. It only generally states that "all functional requirements have been met" and "core functions execute as expected."

Reported Device Performance: The document does not provide numerical results for device performance. It only states: "The result of these tests demonstrates that BR-FHUS Navigation 1.0 validation is with in specification. As such, BR-FHUS Navigation 1.0 is as safe and effective as the predicate devices and is substantially equivalent to existing products on the market today." And "In all instances, BR-FHUS Navigation 1.0 functioned as intended and the operation observed was as expected."

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

• Sample Size for Test Set: Not specified. The document only mentions "breast phantoms" were used.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): "Testing was conducted in-house by trained personnel in a simulated work environment using breast phantoms." This indicates a prospective in-house study. The location of "in-house" is implied to be at TaiHao Medical Inc. (Taiwan, R.O.C.) given their address in the submitter information.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It only states "trained personnel."

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The testing described focuses on the device's functional and accuracy performance using phantoms.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.

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

• Standalone Performance: Yes, the testing described appears to be a standalone performance evaluation of the BR-FHUS Navigation 1.0 software. The device itself is described as a "standalone software device." The performance data section focuses on "functional and accuracy test results" of the software system.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the testing described with "breast phantoms" would be based on the known, measurable positions or characteristics of targets within the phantoms, which serves as a surrogate for anatomical ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not specified. The document does not mention a training set, which suggests the device might not use machine learning in a way that requires a separate training set, or this information was not considered necessary for this 510(k) summary.

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

• How Ground Truth for Training Set Was Established: Not applicable, as no training set information is provided.

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