(212 days)
ACUSON P500 Ultrasound System
The ACUSON P500 ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN (useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.
The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.
ACUSON P500 ICE Ultrasound System
The ACUSON P500 ICE ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN (useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.
The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.
The ACUSON P500 and P500 ICE Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Power(Amplitude) Doppler Mode, a combination of modes and Harmonic Imaging on a Display.
The provided text is an FDA 510(k) clearance letter for the ACUSON P500 and P500 ICE Ultrasound Systems. It does not contain the specific details of acceptance criteria or a study proving the device meets those criteria. The document explicitly states:
"Since the ACUSON P500 and P500 ICE Ultrasound Systems use the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence."
This means that a specific clinical study with acceptance criteria, test sets, expert ground truth, etc., as requested in your prompt, was not performed or submitted for this particular clearance, as the device was deemed substantially equivalent to a previously cleared predicate device.
Therefore, I cannot provide the requested information from the given text.
If you have a document that describes the specific acceptance criteria and a study that proves the device meets them, please provide that document.
§ 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.