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The Cardio P1 Analysis System is intended to acquire, and record ECG information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. The system provides 12-lead ECG and interpretive analysis. The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be a qualified medical professional along with other relevant clinical information. Sending ECG data to and from the Hospital Information System is optional. The Cardio P1 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.

Cardio P1 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its user-oriented design enables ECG examination with a single push of a button. The Cardio P1 is installed on a standalone PC. For all configurations, an independent PC is used that can be positioned for patient convenience.

The provided text is a 510(k) summary for the Cardio P1 device, which is a 12-channel ECG recording equipment. The summary states that clinical testing is not required and that the substantial equivalence is based on non-clinical testing demonstrating similar technological characteristics to the predicate device (Cardio10, K220535). Therefore, the document does not contain information regarding acceptance criteria and a study proving the device meets those criteria for clinical performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, target population, and technical specifications, along with compliance with electrical safety, EMC, usability, and software validation standards.

Specifically, it states:

• "Clinical testing is not required" (page 9)
• "The non-clinical testing demonstrates the subject device (Cardio P1) is substantially equivalent in terms of technological characteristics to the predicate device (K220535)." (page 9)

Given this, I cannot provide the requested table or details about a clinical study's sample size, ground truth, expert qualifications, or MRMC study results because such information is explicitly stated as not being required or performed for this submission. The device performance listed in the comparison table on page 5-6 refers to the technical specifications of the ECG device rather than diagnostic accuracy or clinical outcomes.

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