(319 days)
For Endoscopic Ultrasound Applications using the Balloon Method in the Upper or Lower Gastrointestinal Tract.
Endoscopic Ultrasound Balloon Device Name: Latex Free
The provided text describes a 510(k) clearance letter for the "Endoscopic Ultrasound Balloon" device. It outlines the FDA's determination of substantial equivalence to a predicate device for the stated indications for use.
Crucially, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a detailed study report within this document. While the manufacturer would have submitted testing data to the FDA to support their claim of substantial equivalence, those details are not present in the provided letter.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given input.
§ 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.