The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-raginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color m-Mode, Power/Dirpower mode, TDI mode, 3D/4D mode, Elastography or the combined mode (i.e. B/M-mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.
The provided text is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards rather than detailing acceptance criteria and performance data for a novel algorithm or AI-driven feature.
Based on the provided information, the device is a general-purpose diagnostic ultrasound system, and the submission does not describe a study involving specific acceptance criteria for a novel AI-driven feature or algorithm. The document explicitly states "Clinical Tests: Not Applicable." and relies on non-clinical tests to demonstrate substantial equivalence to predicate devices.
Therefore, the requested information regarding algorithm-specific acceptance criteria, reported performance, sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies with AI assistance is not present in the provided text.
The document indicates that the device meets safety and performance standards through non-clinical testing for compliance with:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)
- IEC 60601-1-2 Edition 3: 2007-03 (Electromagnetic Compatibility)
- IEC 60601-2-37 Edition 2.0 2007 (Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment)
- AAMI / ANSI / IEC 62304:2006 (Medical Device Software - Software Life Cycle Processes)
- ISO 14971 Second edition 2007-03-01 (Medical Devices - Application of Risk Management)
- NEMA UD 2-2004 (R2009) (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment)
- AAMI / ANSI / ISO 10993-1:2009/(R)2013 (Biological Evaluation of Medical Devices)
The performance of the device is implicitly expected to be "substantially equivalent" to the predicate devices (Mindray DC-8 (K170277), Resona 7 (K171233), DC-70 (K163690), and M9 (K171034)) based on shared technology, intended uses, basic operating modes, materials, acoustic power levels, and compliance with safety standards.
In summary, the provided text does not contain detailed information on acceptance criteria and specific study results for a novel AI or algorithm performance, as it is a 510(k) submission focused on demonstrating substantial equivalence through adherence to general safety and performance standards for an ultrasound system.
§ 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.