Ultrasound System 1300

The Ultrasound System 1300 is a versatile, mobile diagnostic ultrasound platform designed for a broad spectrum of clinical imaging applications, utilizing various transducers and advanced imaging modes. It incorporates an AI-driven feature, Prostate Volume Assist (PVA), to enhance workflow efficiency in prostate volume measurements through automated caliper placement, which demonstrated specific deviation percentages compared to manual methods in performance tests.

The Ultrasound System 1300, marketed as bkSpecto, is a mobile, software-controlled diagnostic ultrasound system designed for various imaging applications. It features a console with digital acquisition, processing, and display capabilities, a glass touchpad user interface, and a 19-inch clinical display monitor. The system supports numerous multi-frequency transducers, including endocavity, biplane, triplane, linear array, curved array, phased array, and intraoperative types, catering to diverse diagnostic needs. Key hardware components include the scan engine with three transducer ports and 64 TX/RX channels, and it operates on a Windows 10 OS. Available accessories include a footswitch, printer, and various holders, with model configurations offered with or without a rechargeable battery. This system is intended for use by qualified healthcare professionals for ultrasound imaging, human body fluid flow analysis, and guidance for punctures and biopsies across a wide range of clinical applications. These include fetal, abdominal, pediatric, small organ, cephalic (adult and neonatal), intra-operative (including neurosurgery), trans-rectal, trans-vaginal, musculo-skeletal, adult cardiac, and peripheral vessel imaging. It offers multiple imaging modes such as 2D (B-Mode with Tissue Harmonic Imaging), M-Mode, Vector Flow Imaging, Strain Elastography, CW/PW Doppler, Color Doppler, and Contrast Imaging. A notable update is the introduction of the Prostate Volume Assist (PVA), an AI software feature designed to improve workflow for prostate volume measurement by automatically placing calipers. Performance testing for PVA involved extensive datasets (healthy, diseased, synthesized images) and showed deviations of 7% +/- 15% (for the 9048 transducer) and 11% +/- 6% (for 9018 and 9008 transducers) compared to manual caliper placement by experienced clinicians.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What is the specific algorithm or deep learning architecture used for the Prostate Volume Assist (PVA) feature, and how was it trained to handle variability in prostate anatomy and image quality?; The PVA performance shows a deviation of 7% +/- 15% for the 9048 transducer. What factors contribute to this larger standard deviation compared to other transducers, and are there plans to improve its precision?; How does the "Vector Flow Imaging (VFI)" mode in the Ultrasound System 1300 compare in diagnostic utility and accuracy to traditional Doppler modes for human body fluid flow analysis in specific clinical scenarios like peripheral vascular assessment?; Given the wide range of clinical applications, what specific image optimization settings or transducer-application pairings are recommended for challenging cases, such as imaging obese patients or deep-seated structures?; The document mentions "synthesized data" for training the PVA AI. What methods were used to generate this synthesized data, and how was its realism and utility validated to ensure it contributed positively to the AI model's performance?