(168 days)
The Tayman Medical, Inc. Stepping and Stabilization System is used to provide precision ultrasound probe alignment and radioactive seed implantation in the treatment of prostate cancer.
The seeding device is comprised of three basic components. The adjustable height base. The adjustable, multi-axis head. The ultrasound probe holder and needle guide.
The provided text is a summary of safety and effectiveness for a medical device (Tayman Medical, Inc. Stepping and Stabilization System). It describes the device, its intended use, and its similarities to a predicate device.
However, the document does not contain any information regarding acceptance criteria, study results, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in the prompt.
Therefore, I cannot fulfill the request using the provided input. The document focuses on regulatory equivalence rather than performance evaluation against specific 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.