(13 days)
The APLIO is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial) and laparoscopic.
The APLIO Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz. This submission is to clear cardiac packages already in place on predicate devices.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Toshiba SSA-770A, APLIO Version 4 Diagnostic Ultrasound System. It details the device's technical specifications, intended uses, and its substantial equivalence to previously cleared predicate devices.
However, the document does not contain information regarding acceptance criteria or a specific study that proves the device meets such criteria. The document focuses on regulatory clearance by demonstrating substantial equivalence to existing devices, and lists various transducers with their cleared modes of operation and clinical applications. There are no performance metrics, accuracy statistics, or study designs mentioned that would typically be associated with proving a device meets specific acceptance criteria based on quantifiable performance.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study evaluating its performance against such criteria. The document primarily functions as a regulatory submission detailing the device's characteristics and intended use, rather than a performance evaluation report.
§ 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.