Search Results

Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Adult Cephalic, and Cardiac applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.

The ACUSON P10™ is a general purpose, hand-held, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo and display it in B-Mode, Color Doppler Mode, a combination of these modes, and Harmonic Imaging, on an LCD display.

The provided text describes a 510(k) summary for the ACUSON P10TM Diagnostic Ultrasound System. It focuses on the device's adherence to various safety and performance standards rather than specific clinical performance acceptance criteria and a study to prove meeting those criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and comparative effectiveness studies is not present in the provided document.

The document primarily states that:

• The ACUSON P10™ has been "designed to meet" a list of product safety standards (UL, CSA, NEMA, IEC, ISO, etc.).
• Its acoustic output is "in accordance with ALARA principle (as low as reasonably achievable)".
• The device is "substantially equivalent" to predicate devices, implying similar performance characteristics.
• The FDA issued a substantial equivalence determination based on the information provided, but requested a post-clearance special report to confirm acoustic output measurements from production units.

Without explicit clinical performance acceptance criteria and a study detailing results against those criteria, I cannot fill out the requested table or provide the detailed study information.

The document's focus is on regulatory compliance and substantial equivalence to existing devices, not on a new clinical performance study.

Ask a specific question about this device