(9 days)
The Omnia X/XS ultrasound imaging system is intended for the following applications: General The Ommal XIXO ultraoberative, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Kaulology, Abdominal, Intraoporative, Gular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides for the measurement of anatomical structures and for analysis THE System also provide information that is used for clinical diagnosis purposes.
The Omnia X/XS 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, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, or 3D imaging, on a CRT display.
The provided document is a 510(k) Summary for the Siemens Omnia X/XS Diagnostic Ultrasound System, dated December 19, 2001. It outlines the device description, intended uses, and technological comparison to predicate devices for regulatory clearance.
This document does not contain information about acceptance criteria or specific studies showing device performance against such criteria. The "Indications for Use Form" (Attachments 4-20) lists the clinical applications each transducer is intended for and the available modes of operation, indicating whether these are "new" (N), "previously cleared" (P), or "added under Appendix E" (E) applications. However, these forms do not provide quantitative performance metrics, sample sizes, ground truth establishment, or details about study methodologies.
Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them from the provided text. The document focuses on regulatory classification and intended use rather than detailed performance study results.
§ 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.