(67 days)
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult & pediatric); Peripheral Vascular (PV); and Urology (including prostate).
E-CUBE 9 product is an ultrasound imaging system for medical diagnosis. This product can be used for the applications of abdominal, obstetrics, gynecology, small parts, cardiology, vascular, etc. The system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality
The provided documentation does not contain detailed acceptance criteria for specific performance metrics of the E-CUBE 9 ultrasound system in a clinical context. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K060993 LOGIQ P5/A5 Diagnostic Ultrasound System) through non-clinical tests and a declaration that clinical studies were not required.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for clinical performance cannot be extracted from this document.
The document mainly highlights:
- Non-Clinical Tests: Evaluation for biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards.
- Voluntary Standards Compliance: The device's application complies with voluntary standards as detailed in the premarket submission.
- Quality Management System Measures: Mention of Medical Device Risk Management, Requirements Reviews, Design Reviews, Component Verification, Integration Review (System Verification), Performance Testing (System Verification), Safety Testing (Compliance Test), and Design Validation.
The key statement regarding clinical data is:
"The subject of this premarket submission, E-CUBE 9, did not require clinical studies to support substantial equivalence."
This indicates that the FDA granted clearance based on non-clinical data and the device's technical similarity to a previously cleared device, rather than requiring new clinical performance studies with specific acceptance criteria that would typically be evaluated in such studies.
§ 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.