(113 days)
The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel color LCD/TFT touch panel color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.
The provided document is a 510(k) Premarket Notification Submission for the GE Healthcare Voluson E6, Voluson E8, and Voluson E10 ultrasound systems. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for an AI/ML-driven medical device. Instead, it details the substantial equivalence of the new Voluson E Series models to previously cleared predicate devices, primarily focusing on modifications to the ultrasound system itself and new transducer capabilities.
Specifically, the document states:
- "Summary of Clinical Tests: The subject of this premarket submission, Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10), did not require clinical studies to support substantial equivalence."
This indicates that clinical performance data for proving specific acceptance criteria related to AI/ML device performance (like accuracy, sensitivity, specificity, or human improvement with AI assistance) was not part of this particular submission for the overall ultrasound system.
The document mentions new software features like "IOTA Adnex Model" and "SonoCNS (Sono Central Nervous System)," but it does not specify performance metrics or studies conducted to establish their acceptance criteria or prove their performance. The "IOTA Adnex Model" is described as a tool to aid in the diagnosis of cancer by giving a probability of risk, explicitly stating "this software cannot be used to diagnose cancer." This suggests it is a non-diagnostic aid, which typically has different regulatory requirements compared to diagnostic AI/ML algorithms.
Therefore, based on the provided text, I cannot describe the acceptance criteria or a study proving the device meets those criteria for an AI/ML device as it's not present in this 510(k) summary. The submission focuses on hardware and existing technology equivalence.
§ 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.