Search Results

The Xario is intended to be used for the following type of studies; fetal, abdominal. pediatric, small organs, cardiac, transvaginal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

The Xario Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.

The provided text is a 510(k) Summary for the Toshiba SSA-660A, Xario Version 1.00 Diagnostic Ultrasound System. It describes the device, its intended use, safety considerations, and its substantial equivalence to a predicate device (Toshiba SSA-770A, Aplio Version 5.5). The document primarily focuses on regulatory classification and indications for use for the system and various transducers.

However, the provided text does not contain information regarding detailed acceptance criteria, a specific study proving device performance against acceptance criteria, sample sizes used, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, types of ground truth, or details about the training set.

The tables on pages 4-13 list "Clinical Application" and "Mode of Operation" for the main system and individual transducers, indicating which modes are "new indications" (N) for each application. This is about intended use and capabilities, not performance metrics or studies against acceptance criteria. The "N" indicates that this is a new clinical application or mode for this specific model, being compared against the predicate device's existing capabilities. It does not provide performance metrics.

The document states that the device is "designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-2 (applicable portion), IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard." These are safety and performance standards that the device likely meets, but the document does not elaborate on the specific acceptance criteria or studies proving that it meets these standards, beyond a general statement of compliance.

Therefore, I cannot populate the requested table or answer most of the questions based on the provided text. The document is a regulatory submission for substantial equivalence, which typically focuses on comparing the new device's features and safety to an already cleared device, rather than providing detailed performance study results against specific acceptance criteria.

Ask a specific question about this device