(57 days)
The Viamo SSA-640 v1.2 Ultrasound System is indicated for the visualization of structures, characteristics, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, and musculo-skeletal (both conventional and superficial).
The Viamo is a mobile system. It is a Track 3 device that employs a wide range of probes that include flat linear array, convex array and sector array with a frequency range of approximately 2.5 MHz to 7.5 MHz.
The provided text is a 510(k) summary for the Toshiba Viamo SSA-640A Version 1.2 Diagnostic Ultrasound System. This document focuses on the substantial equivalence of the new device to previously cleared predicate devices and outlines its technical specifications and intended uses. It does not contain information related to acceptance criteria, specific device performance metrics (such as sensitivity, specificity, or accuracy), or details of a clinical study designed to test the device's performance against such criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these types of clinical performance evaluations are typically not included or required in a 510(k) for a diagnostic ultrasound system that is being cleared based on substantial equivalence to existing devices.
The document primarily covers:
- Device Description: A mobile ultrasound system with various probes and frequency ranges.
- Intended Use: Visualization of structures, characteristics, and dynamic processes within the human body for diagnosis in applications such as fetal, abdominal, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, and musculo-skeletal.
- Predicate Device Identification: Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V4.0 510(k) ● K091295.
- Transducer Information: A list of transducers (PST-25ST, PVT-375ST, PLT-704ST, PLT-805AT, PVT-382BT) and the specific clinical applications for which each is indicated, along with the available modes of operation.
The absence of performance study details is characteristic of 510(k) submissions for devices like diagnostic ultrasound systems, where substantial equivalence is often demonstrated through technological similarity and adherence to recognized standards, rather than direct clinical performance comparison against acceptance criteria in a study.
§ 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.