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The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, Color Doppler, Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid.

The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.

The SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications. The Digital Color Doppler Palm Ultrasound System includes:

• A commercial off-the-shelf (COTS) Android mobile device
• CHISON Ultrasound software is running as an app (Android) on the COTS device
• The SonoEye P2, SonoEye V2, SonoEye G2 Linear array USB transducer

The provided FDA 510(k) summary (K201967) for the CHISON SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria for AI-assisted image analysis.

The document focuses on demonstrating substantial equivalence to predicate devices for its general diagnostic ultrasound imaging capabilities, particularly in B (2D), B/M, Color Doppler, Combined (B+Color), Pulsed Wave, and Fusion Harmonic Imaging modes. The non-clinical tests mentioned primarily relate to electrical, mechanical, thermal, electromagnetic compatibility, and biocompatibility safety, as well as acoustic output.

Specifically, the document states:

• "No clinical testing was required." This indicates that no clinical study was performed to assess the device's diagnostic performance, let alone an AI component.
• The "Comparison Analysis" and "Substantially Equivalent Conclusion" sections primarily compare the device's technical specifications and operating controls to predicate devices, noting differences in value ranges (e.g., depth, voltage, temperature, humidity) and confirming compliance with safety standards (IEC60601-1, IEC60601-1-2, IEC60601-2-37, ISO 10993-1).

Therefore, based on the provided text, I cannot extract the requested information about acceptance criteria and a study proving a device's performance, as such details are not present for an AI component. The device described appears to be a diagnostic ultrasound system whose substantial equivalence is established through engineering and safety comparisons, not performance metrics from a clinical or AI evaluation study.

If an AI component is implied, it is not explicitly detailed with performance metrics or studies in this document. The listed product codes (IYN, IYO, ITX) are for general ultrasonic imaging systems and transducers, not specifically for AI/CADx devices.

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