(182 days)
Clarius OB Al is intended to assist in measurements of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur length, bi-parietal diameter, crown rump length) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear scanner). 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 OB Al is indicated for use in adult patients only.
Clarius OB Al is a machine learning algorithm that is incorporated into the Clarius App software as part of the complete Clarius Ultrasound Scanner system for use in obstetric (OB) ultrasound imaging applications. Clarius OB Al is intended for use by trained healthcare practitioners for non-invasive measurements of fetal biometric parameters on ultrasound data acquired by the Clarius Ultrasound Scanner system (i.e., curvilinear scanner) using a deep learning image segmentation algorithm.
During the ultrasound imaging procedure, the anatomical site is selected through a preset software selection (i.e., OB, Early OB) within the Clarius App in which Clarius OB Al will engage to segment the fetal anatomy and place calipers for measurement of fetal biometric parameters.
Clarius OB Al operates by performing the following tasks:
- Automatic detection and measurement of head circumference (HC)
- Automatic detection and measurement of abdominal circumference (AC)
- Automatic detection and measurement of femur length (FL)
- Automatic detection and measurement of bi-parietal diameter (BPD)
- Automatic detection and measurement of crown rump length (CRL)
Clarius OB Al operates by performing automatic measurements of fetal biometric parameters. The user has the option to manually adjust the measurements made by Clarius OB Al by moving the caliper crosshairs. Clarius OB Al does not perform any functions that could not be accomplished manually by a trained and qualified user. Clarius OB AI is intended for use in B-Mode only.
Clarius OB Al is an assistive tool intended to inform clinical management and is not intended to replace The clinician retains the ultimate responsibility of ascertaining the clinical decision-making. measurements based on standard practices and clinical judgment. Clarius OB Al is indicated for use in adult patients only.
Clarius OB Al is incorporated 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 transducer (previously 510(k)-cleared in K213436). Clarius OB Al is not a stand-alone software device.
Here's a summary of the acceptance criteria and study details for the Clarius OB AI device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implicit) | Clarius OB AI Reported Performance |
|---|---|---|
| Fetal Biometric Measurements (HC, AC, FL, BPD, CRL) | Non-inferiority to manual measurements performed by qualified experts | Clarius OB AI was found to be non-inferior to human experts with statistically significant p-values ( |
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.