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The SONOACE R5 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult and Peripheral vessel.

The SONOACE R5 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging, PW Spectral Doppler mode, Harmonic imaging, Freehand 3D imaging mode or as a combination of these modes. The SONOACE RS also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SONOACE R5 has real time acoustic output display with two basic indices, a mechanical index, which are both automatically displaved.

The provided text is a 510(k) Premarket Notification for the SONOACE R5 Diagnostic Ultrasound System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical data, sensitivity, specificity, or reader studies.

The document focuses on:

• Substantial Equivalence: The primary assertion is that the SONOACE R5 is substantially equivalent to the SONOACE R3 (K101829) and SONOACE R7 (K102065) diagnostic ultrasound systems. This means it has the same intended use and similar technological characteristics to legally marketed devices, or has different technological characteristics but does not raise different questions of safety and effectiveness.
• Safety Standards: The document lists various general product safety and acoustic output standards (e.g., UL 60601-1, IEC60601-2-37, NEMA UD-2/3, ISO10993-1) that the device has been designed to meet. Meeting these standards is a form of acceptance criteria, but they relate to general device safety and acoustic output, not specific diagnostic imaging performance metrics (like sensitivity/specificity for a particular clinical application).
• Intended Use and Clinical Applications: It outlines the broad range of clinical applications for which the system and its transducers are intended (e.g., Fetal, Abdominal, Cardiac Adult, Peripheral Vessel).

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance from a clinical study, sample sizes, ground truth establishment, or expert details because this information is not present in the provided 510(k) summary. A 510(k) notification often relies on substantial equivalence and non-clinical performance data (like meeting engineering standards) rather than presenting new clinical study data with detailed performance metrics like sensitivity/specificity for a specific diagnostic task.

If such a study were required and performed, it would typically be detailed in a separate section of a more extensive submission, which is beyond the scope of this particular 510(k) summary.

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