Search Results

Not Found

Not Found

The provided text describes the safety and effectiveness of the Neosono XX device, focusing on its design and internal testing rather than a clinical study with acceptance criteria. As such, I cannot extract the requested information. The text does not contain:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test sets or data provenance.
• Details on experts used for ground truth establishment or their qualifications.
• Adjudication methods for a test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document focuses on internal safety checks (power source, device failure modes like circuitry failure, open/shorted wires, low battery) and the technical approach to effectiveness (impedance measurement, handling environmental variations, and probe wire integrity). It highlights design features and internal self-tests that address potential issues.

Ask a specific question about this device

Ask a specific question about this device