Search Results

The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified physicians, physician assistants, sonographers and ultrasound technicians in a healthcare facility for diagnostic ultrasound imaging or fluid flow analysis of the human body in B-Mode (2D), Color Flow Imaging Modes (Color Doppler and Power Doppler) and Combined (B-Mode + CFI Modes). The indications for use are:

• Small Organ
• Transrectal ●
• Abdominal ●

The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System comprises of transducers responsible for ultrasound signal generation and recording, needle guides and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

The provided document describes the FDA 510(k) summary for the ExactVu™ High Resolution Micro-Ultrasound System (K192303). It outlines the device, its intended use, comparison to a predicate device, and non-clinical performance testing.

However, the document explicitly states:
"This technology is not new; therefore, a clinical study was not considered necessary prior to release. The substantial equivalence of the device is supported by the nonclinical testing."

This means that the provided text does not contain any information about a clinical study involving the device's performance against acceptance criteria in a real-world setting with human subjects, AI assistance, or expert readers. The document focuses solely on non-clinical performance testing (e.g., functional verification, human factors, biocompatibility, electrical safety, acoustic testing) to establish substantial equivalence to a previously cleared predicate device.

Therefore, I cannot provide answers to the requested points that pertain to clinical study data, such as:

• A table of acceptance criteria and reported device performance from a clinical study.
• Sample size used for a test set (clinical).
• Number of experts and qualifications for ground truth establishment.
• Adjudication method for a clinical test set.
• MRMC comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used (clinical).
• Sample size for the training set (clinical).
• How ground truth for the training set was established (clinical).

Based on the provided text, the device's acceptance was based on non-clinical performance testing demonstrating substantial equivalence to a predicate device, not on a clinical study with a test set, expert readers, or AI performance metrics.

Ask a specific question about this device