(12 days)
The UGEO G60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include:Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Transrectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), and Peripheral vessel.
The UGEO G60 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging(including Directional Power Doppler mode; S-Flow), PWSpectral Doppler mode, Harmonic imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The UGEO G60 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The UGEO G60 has real time acoustic output display with two basic inclices, a mechanical index and a thermal index, which are both automatically displayed.
The provided text describes a 510(k) Premarket Notification for the UGEO G60 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a new AI/algorithm-based device.
Therefore, the requested information regarding acceptance criteria, study details for AI/algorithm performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data provenance is not available within this document.
The document primarily states:
- The device description for the UGEO G60, which is a general-purpose, mobile, software-controlled diagnostic ultrasound system.
- Its intended uses for diagnostic ultrasound imaging and fluid analysis of the human body across various clinical applications (Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Transrectal, Trans-vaginal, Muscular-Skeletal, Peripheral vessel).
- Its technological characteristics, emphasizing its substantial equivalence to previously cleared predicate devices (ACCUVIX A30 Diagnostic Ultrasound System K112339 and ACCUVIX V20 Diagnostic Ultrasound System K092159). This means the core functionality and performance are considered similar to these existing devices.
- Compliance with various product safety standards.
- Tables listing the clinical applications and modes of operation for various transducers for which the device is intended. The "N" signifies a new indication, and "P" signifies a previously cleared indication, referring to the predicate devices.
In summary, this document is a regulatory submission for a diagnostic ultrasound system and does not contain the type of AI/algorithm performance study data you are asking for, as the device itself is not described as an AI-powered diagnostic tool requiring such rigorous testing for novel performance claims.
§ 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.