(180 days)
The HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.
The systems support the following clinical applications:
The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, peripheral vessel, and urology exams.
Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/ Power/PWD.
The HD60 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD60 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN.
The provided text is a 510(k) Premarket Notification Submission for the Hisense HD60 Series Ultrasound Diagnostic System. It does not describe a study that proves the device meets specific acceptance criteria for AI/ML performance. Instead, it details the substantial equivalence of the HD60 Series to a predicate device (Mindray DC-80 Ultrasound Diagnostic System, K192152) based on general ultrasound system performance and safety standards.
Therefore, I cannot create a table of acceptance criteria and reported device performance related to AI/ML, nor can I describe study details like sample size, ground truth establishment, expert adjudication, or MRMC studies for AI/ML performance, as this information is not present in the provided document.
The document focuses on:
- Intended Use and Indications for Use: General purpose ultrasound imaging, measurement, display, and analysis for various clinical applications (fetal, abdominal, pediatric, etc.).
- Comparison to Predicate Device: Highlighting similarities in fundamental scientific technology, patient contact materials, modes of operation, and basic measurements.
- Differences: Noting the HD60 Series omitting intra-operative and trans-esophageal applications, and introducing a "Teaching System" feature.
- Non-clinical Tests: Compliance with various safety, biocompatibility, and electromagnetic standards relevant to general medical electrical equipment and ultrasound devices (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-37, ISO 10993).
- Clinical Tests: Stating that no clinical studies were required to support substantial equivalence.
In summary, the provided text does not contain the information required to answer your specific questions about AI/ML acceptance criteria and performance studies, as the device described is a general ultrasound diagnostic system and not explicitly an AI/ML-driven device with such specific performance metrics detailed.
§ 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.