(256 days)
Pocket Ultrasound System(Model:P50,P51,P52,P53,P54,P55,P56) is intended for use by an appropriately trained, qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid), Peripheral Vascular, Urology. The system is suitable for use in hospital and clinical settings.
The Pocket Ultrasound System is designed to be high-end Pocket Ultrasound Systems and mainly include the ultrasound equipment and APP software components.6 models the the the main units are included in this submission, for including P50,P51,P52,P53,P53,P55,P56.
The equipment to complete the ultrasonic imaging function; APP complete the image display, measurement, patient information and image storage and other applications. APP can be deployed on Windows or Android devices which supported WIFI. There are two free APPs to support different systems. The communication protocol between APP and the system is specially defined by ourself, and other manufacturers can not use this protocol. The ultrasound device and the APP software transfer images and control instructions via WIFI.
Different type transducers are available for different model of Pocket Ultrasound System, the frequency scope of different transducer are from 3.5MHz to 6.5MHz.
The system provides a variety of modes for flexibly selecting, which include B-mode, M-mode, Color-mode, Power-mode, PW-mode, and combined modes (i.e. B/M- mode). Real time image and dynamic changes of tissues, organs or vessels will be showed in the image under B-mode, while coloring blood flow can be seen under Color-mode, PW-mode or Power-mode. M-mode is defined as time motion display of the ultrasound wave along a chosen ultrasound line, so it 's usually applied in diagnosis of cardiovascular diseases.
The system not only provides real-time tissues, organs or blood flow images, but also contains measurement of anatomical structures and analysis packages, which can offer diagnosticians detailed and useful information. The embedded software system along with the touch screen offer users a friendly and convenient graphical interface, which make users be able to easily control the whole system.
The provided text does not contain detailed information about acceptance criteria for an AI-powered device, nor does it describe a study proving the device meets specific performance criteria. Instead, it is a 510(k) summary for a Pocket Ultrasound System, which appears to be a medical device, but not explicitly an AI-powered one in the context of diagnostic assistance.
The document focuses on demonstrating substantial equivalence to a predicate device (Clarius Ultrasound Scanner, K192107) based on technical characteristics, intended use, and adherence to safety standards.
Therefore, I cannot fulfill the request for information regarding AI acceptance criteria and performance studies. The document explicitly states:
- "The subject of this premarket submission, Pocket ultrasound system did not require clinical studies to support substantial equivalence." This indicates that no human-in-the-loop clinical studies were conducted for this submission to evaluate diagnostic performance.
- The tests mentioned are primarily non-clinical tests verifying safety, electrical compatibility, biocompatibility, and acoustic output, along with software verification and wireless performance.
If this device were AI-powered and required demonstration of diagnostic accuracy, the information requested in your prompt (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) would typically be found in a separate clinical performance study section, which is absent here.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.