(14 days)
Diagnostic imaging or fluid flow analysis of the human body as follows: General Radiology, Cardiac, Pelvic, Neonatal/Adult Cephalic, Abdominal, Small Parts, Transvaginal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis that is used for clinical diagnosis purposes.
The G20 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, a combination of modes, 3D imaging or Harmonic Imaging on a CRT display.
The provided text describes a 510(k) summary for the SONOLINE G20 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices and lists the intended uses and compliance with safety standards. It does not contain information about acceptance criteria or specific studies evaluating device performance in terms of clinical accuracy or effectiveness.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, or ground truth establishment.
The document primarily states:
- Intended Uses: General Radiology, Cardiac, Pelvic, Neonatal/Adult Cephalic, Abdominal, Small Parts, Transcranial, Superficial Musculoskeletal, and Peripheral Vascular applications, including measurement of anatomical structures and fluid flow.
- Technological Comparison: The G20 is substantially equivalent to predicate devices (SONOLINE Adara K946179, SONOLINE G20 K040502, SONOLINE G50 & G60 S K020353).
- Compliance: Designed to meet various product safety standards (UL, CSA, AIUM/NEMA, 93/42/EEC Medical Devices Directive, EN, IEC, ISO).
No studies assessing specific image quality metrics or diagnostic accuracy are detailed in this 510(k) summary. The FDA letter requests a post-clearance special report with acoustic output measurements based on production line devices, which relates to safety rather than clinical performance.
§ 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.