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Clarius Median Nerve AI is intended for segmentation and semi-automatic non-invasive measurements of the median nerve cross-sectional area on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., linear array scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius Median Nerve Al is indicated for use in adult patients only.

Clarius Median Nerve AI is a machine learning algorithm that is integrated into the Clarius App software as part of the complete Clarius Ultrasound Scanner system for use in musculoskeletal ultrasound applications, specifically intended for segmentation and measurement of the cross-sectional area of the median nerve. Clarius Median Nerve AI is intended for use by trained healthcare practitioners for measurement of the cross-sectional area (CSA) of the median nerve on ultrasound data acquired by the Clarius Ultrasound Scanner system (i.e., linear array scanners) using a deep learning image segmentation algorithm.

During the ultrasound imaging procedure, the anatomical site is selected through a preset software selection (i.e., Hand/Wrist) from the Clarius App in which Clarius Median Nerve AI will segment the median nerve in transverse view (with a segmentation mask placed on the ultrasound image) and engage to automatically place calipers on the segmentation mask to measure the median nerve's cross-sectional area.

Clarius Median Nerve AI operates by performing the following tasks:
• Automatic detection and measurement of the median nerve in transverse view

Clarius Median Nerve AI operates by identifying and segmenting the median nerve in the forearm and wrist and performs automatic measurements of the median nerve's cross-sectional area. The user has the option to manually adjust the measurements made by Clarius Median Nerve AI by moving the caliper crosshairs. Clarius Median Nerve AI does not perform any functions that could not be accomplished manually by a trained and qualified user.

Clarius Median Nerve AI is an assistive tool intended to inform clinical management and is not intended to replace clinical decision-making. The clinician retains the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Median Nerve AI is indicated for use in adult patients only.

Clarius Median Nerve AI is integrated into the Clarius App software, which is compatible with iOS and Android operating systems two versions prior to the latest iOS or Android stable release build and is intended for use with the following Clarius Ultrasound Scanner system transducers (previously 510(k)-cleared in K213436). Clarius Median Nerve AI is not a stand-alone software device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance document for Clarius Median Nerve AI:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance:

Equivalence/error margin: 3 mm² | Non-inferiority demonstrated: |
| Clinical Performance - Cross-sectional Area (CSA) Measurement | p-value for non-inferiority

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