(80 days)
The Ultrasound System SONIMAGE MX1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes. The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display and/or Doppler sound, offers a procedure applied to the human body for medical diagnosis or examination.
The range of intended clinical applications is same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, musculoskeletal, cardiac, and peripheral vascular.
This device is intended for use in healthcare facilities, such as health clinics and hospitals.
Intended user for the device are physician, sonographer, and other trained qualified healthcare professionals.
Modes of operation include B-mode, PWD-mode, CWD-mode, Color Doppler-mode, Power Doppler-mode, and their Combined mode.
The Ultrasound System SONIMAGE MX1 is a portable diagnostic ultrasound system for general purposes. The system provides ultrasound imaging information such as used for the purpose of diagnosing the human body, which visually represents the internal geometry, characteristics and dynamics of the human body, and transmits / receives ultrasound waves to obtain image data of the visual representation.
This system provides ultrasound images in conventional modes of B-mode, M-mode, Color Doppler-mode, Power Doppler-mode, PW Doppler-mode and CW Doppler-mode.
The optional items are available, such as a Cradle, a Three port probe unit, an Additional Battery, and a Foot Switch with dual/triple pedals.
The system can be connected to LAN through the wired Ethernet and, is also capable of wireless LAN with the OTS USB-WiFi adapter supporting security of WPA/WPA2 and WEP.
This system conforms to Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment (Track 3). Transducers have their own characteristic applications and are brought into contact with the body surface.
The provided text is a 510(k) summary for the Konica Minolta Ultrasound System SONIMAGE MX1. It does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria through a human-in-the-loop or standalone AI study.
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K180084). The "Performance Data" section primarily lists compliance with various medical device standards (e.g., AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, IEC 62304) and references relevant FDA guidance documents for diagnostic ultrasound systems, software, and cybersecurity.
The key statement regarding performance is: "Risk Analysis and verification and validation activities demonstrate that the established specifications for these devices have been met. The results of risk management did not require clinical studies to demonstrate the substantial equivalency of the proposed device." This indicates that the device's performance was evaluated through engineering verification and validation (V&V) activities against technical specifications and established standards, rather than clinical studies involving human readers or AI algorithms with specific performance metrics like sensitivity, specificity, or AUC.
Therefore, I cannot provide the requested information because it is not present in the provided document. The document describes a regulatory submission based on substantial equivalence, relying on standard compliance and V&V activities, not a performance study as typically seen for AI/ML-driven devices requiring clinical validation against defined acceptance criteria.
§ 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.