Search Results

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal; Pediatric; Small Organ (breast, thyroid, testes); Peripheral Vascular; Musculo-skeletal (conventional) and Urology.

The SonoScape SSI-1000/SSI-5000 ultrasound system is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations.

The SonoScape System can be configured either as a portable (SSI-1000) model, or as a roll-around model on wheels (SSI-5000).

This is an FDA 510(k) Premarket Notification document, which primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria. Therefore, the information requested about a device performance study, acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not present in this document.

The document lists the intended uses for various transducers of the SonoScape SSI-1000/SSI-5000 Diagnostic Ultrasound System. These tables show what the device is intended to do (e.g., "Abdominal", "Cardiac", "Small Organ" imaging) and which modes of operation it supports for each application (e.g., B-mode, M-mode, Pulsed Wave Doppler, Color Doppler). The 'P' indicates 'previously cleared by FDA', 'N' indicates 'new indication', and 'E' indicates 'added under Appendix E'.

While this document confirms the intended uses, it does not provide specific performance metrics (e.g., accuracy, sensitivity, specificity) for these uses against defined acceptance criteria, nor does it describe a study to demonstrate such performance characteristics. The basis for clearance is substantial equivalence to predicate devices, implying that the new device performs at least as well as the older cleared devices, but without detailing specific comparative performance data in this summary.

Therefore, I cannot provide the requested information regarding acceptance criteria and the performance study, as it is not contained within the provided text.

Ask a specific question about this device