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Voluson Signature 18 / Voluson Signature 20 system are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson Signature 18 / Voluson Signature 20 system clinical applications include: Fetal/Obstetrics; Abdominal (including Renal and Gynecology/ Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic: Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).

Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shearwave Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/ PWD, B/Power/PWD. The Voluson Signature 18 / Voluson Signature 20 system are intended to be used in a hospital or medical clinic.

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.

The provided text is a 510(k) summary for the GE Voluson Signature 20 and Signature 18 diagnostic ultrasound systems. This document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance. It does not describe an AI/software-as-a-medical-device (SaMD) study with specific acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, accuracy).

The document states: "The subject of this premarket submission, Voluson Signature 20/18 did not require clinical studies to support substantial equivalence." This indicates that no specific performance study, clinical or otherwise, was conducted to demonstrate the device meets acceptance criteria using test sets, expert ground truth, or MRMC studies that would be typical for an AI/SaMD product.

Instead, the summary emphasizes that the new device shares fundamental scientific technology with its predicate, has the same clinical intended use (with additional migrated features from other cleared devices like Shearwave Elastography, which is an imaging mode, not an AI algorithm performing diagnostic interpretation), and complies with relevant safety and performance standards for ultrasound systems.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details for an AI component from this document because it does not describe such a study. The "acceptance criteria" here are implicitly the regulatory requirements for showing substantial equivalence for an ultrasound system, focusing on safety, fundamental technology, and similar intended use.

In summary, based on the provided text, the device did not undergo the type of study described in your request for AI/SaMD products.

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