(64 days)
An ultrasound accessory device used for positioning and guiding an ultrasound transducer probe during volume measurements of the prostate. Used in conjunction with a needle guide grid or radiation seed needle placement for the deposit of seeds.
Transducer Positioner
This appears to be a 510(k) clearance letter from the FDA for a device called "Ultrasound Transducer Positioner" (K973622). This type of document is a notification that the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device, rather than a detailed study report proving its performance based on specific acceptance criteria.
Therefore, the provided text does not contain the information requested regarding acceptance criteria, reported device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment.
A 510(k) clearance typically relies on demonstrating substantial equivalence to a predicate device that has already established its safety and effectiveness. It does not usually involve new clinical trials with detailed performance metrics and acceptance criteria in the way a PMA (Pre-Market Approval) or other clinical study reports might.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or a detailed performance validation report for the device.
Without that information, I cannot fill out the requested table or answer the specific questions about acceptance criteria and the study that proves the device meets them.
§ 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.