(6 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Small Organ (Testes), Transrectal.
Mediwatch Multiscan Ultrasound System / Scanner
I am sorry, but the provided text does not contain information regarding acceptance criteria, study data, or ground truth establishment for a medical device. The document is an FDA 510(k) clearance letter for the Mediwatch Multiscan Ultrasound System, which affirms its substantial equivalence to a predicate device. It lists the intended uses and associated transducers but does not provide performance metrics or details of studies conducted to prove these criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.