(177 days)
Endoscopic Ultrasonic Diagnostic Equipment/Disposable Sterile Ultrasonic Probe is intended to be used in conjunction with ultrasound endoscopes to acquire and display real-time ultrasound images of the target organs. This device is indicated for intraluminal ultrasound imaging of the upper respiratory tract and bronchus, digestive tract, and hepatobiliary and pancreatic organs.
Mode of operation includes B mode. This device is intended for use by a qualified and trained healthcare professional in a hospital setting or medical clinic.
Endoscopic Ultrasonic Diagnostic Equipment consist of main unit, control panel, driver box, trolley, and display,it is used in conjunction with Disposable Sterile Endoscopic Ultrasonic Probe to acquire and display high-resolution and high-penetration.real-time ultrasound images of the target organs. Disposable Sterile Endoscopic Ultrasonic Probe is single-use.
The subject system only has B mode.
The subject system provide measurements and calculations of distance,area,circumference, it also allows for the storage and retrieval of images for reviewing and printing.
The subject system enables the user to print and record images to an external recording device.
The subject system will be used with compatible endoscope system : Bronchoscope System (EOS-H-01, Shanghai AnQin Medical Instrument Co.Ltd)cleared under K211169.
-working length maximum 600mm
-Insrument channel dimaeter minimum 1.7mm
The provided text describes the 510(k) premarket notification for an "Endoscopic Ultrasonic Diagnostic Equipment/Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1, USW140-S20MS)". However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through an AI/algorithm-driven performance study.
The document details the device's indications for use, technological characteristics, and comparisons to predicate devices (K951994 and K944610). It mentions non-clinical tests performed, such as acoustic output, electrical safety, biocompatibility, software verification, and cybersecurity. Crucially, it explicitly states:
- "Performance testing - Animal: No animal study was performed to demonstrate substantial equivalence."
- "Performance testing - Clinical: No clinical study was performed to demonstrate substantial equivalence."
This indicates that the substantial equivalence determination for this device was based on technological comparison and non-clinical testing rather than performance in a clinical study demonstrating specific accuracy metrics against a ground truth, especially not one involving AI or human-in-the-loop performance.
Therefore, I cannot fulfill the request to provide details on acceptance criteria and a study that proves the device meets them, as the provided text explicitly states that no such clinical or animal performance studies were conducted for the substantial equivalence determination. The questions about sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable to the information given in this 510(k) summary.
§ 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.