(184 days)
The GYNESONICS EC6 Ultrasound Transducer is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.
The GYNESONICS Model EC6 Ultrasound Transducer is intended for use with the TERATECH t3000, a portable ultrasound imaging system.
The provided text describes a 510(k) Summary for a medical device, the GYNESONICS Model EC6 Probe, which is a diagnostic ultrasound transducer. The document focuses on establishing substantial equivalence to predicate devices and detailing the intended use and technical specifications. It does not contain information about acceptance criteria for performance, a study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information from the given text. The text does not elaborate on a study demonstrating the device's meeting of acceptance criteria.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.