(24 days)
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body.
The system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.
The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-shelf (OTS) iOS or Android device. The Clarius Ultrasound Scanner comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices.
The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals, including the emergency medical services (EMS) environment.
The Clarius Ultrasound Scanner comprises the following:
Transducers/ Scanners (various models): C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3, PA HD3, L20 HD3
Software: Clarius Ultrasound App (Clarius App) for iOS; Clarius Ultrasound App (Clarius App) for Android
Accessories: Clarius Charger, Clarius Fan
This document does not contain information about acceptance criteria or specific study results for the Clarius Ultrasound Scanner related to diagnostic accuracy performance metrics (e.g., sensitivity, specificity, AUC).
The provided text from the FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device by comparing:
- Intended Use and Indications for Use: These are identical between the subject and predicate devices.
- Technological Characteristics: Principle of operation, transducer types, software, modes of operation, wireless communication, and portability are similar. The only noted difference is the power source (internal integrated for the subject device vs. removable for the predicate).
- Compliance with Recognized Standards: Both devices comply with a comprehensive list of medical device safety, EMC, usability, and acoustic output standards (e.g., IEC 60601 series, ISO 10993, NEMA UD 2 & 3, IEC 62304, IEC 62366-1, ISO 14971).
The "Non-Clinical Performance Testing" section broadly states that "The device's safety and performance were verified by tests conducted by Clarius and accredited third-party laboratories. Validation testing was performed to ensure that the final product is capable of meeting the requirements for the specified clinical applications and performs as intended to meet users' needs, while demonstrating substantial equivalence to the predicate device." However, it does not provide specific acceptance criteria or quantitative performance results from these tests. These tests likely pertain to the engineering and safety standards listed, rather than diagnostic performance metrics typically associated with AI/ML devices.
Therefore, I cannot provide the requested information from the given text, particularly regarding a table of acceptance criteria and reported device performance (in terms of diagnostic accuracy), details on sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance. The device described is a general diagnostic ultrasound system, not an AI/ML-driven diagnostic aid that would typically have such performance criteria explicitly detailed in a 510(k) summary for clinical performance.
§ 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.