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The system is used in a cardiac catheterization laboratory where ECG, intracardiac signals, and pressure recordings need to be recorded from a patient.

The CardioCath system is a multi-channel pressure and electrocardiograph system that digitizes, and stores pressure and electrical signal information on magnetic media. The CardioCath system is a data acquisition unit which connects to the patient to collect both electrical ECG and intracardiac signals as well as pressure waveforms acquired by various pressure transducers. The data is digitized and stored in a computer which displays the data on video monitors. The system allows the user to archive, perform signal measurements and to print out signals on both continuous paper recorder or on a laser printer. The system provides isolation of biopotential signals from the patient to ground, high impedance inputs, high gain and variable filtering capabilities required for measuring bioelectric potentials. The system provides isolation, conditioning and amplifications of electrical signals from strain gage blood pressure transducers. The system is microprocessor based and feature graphical user interfaces. The system allows the user to acquire, display, measure and printout various biopotential waveforms.

The provided text does not contain information about specific acceptance criteria related to a device's performance (e.g., accuracy, sensitivity, specificity) or any studies that demonstrate the device meets such criteria.

Instead, the document details a 510(k) Summary for the "CardioCath Catheterization Lab System," focusing on its substantial equivalence to predicate devices and adherence to safety standards.

Therefore, I cannot fulfill your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format you provided, as the necessary information is not present in the input text.

The text primarily covers:

• Device Identification: Trade name, common name, manufacturer.
• Classification: Class II device (74 DPS).
• Predicate Devices: Quinton Q-Cath, Marquette MAC-Lab.
• Similarities & Differences: Physical characteristics, signal acquisition capabilities, display, storage, and processing features.
• Intended Use: Recording ECG, intracardiac signals, and pressure in a cardiac catheterization laboratory.
• Safety Standards: Adherence to IEC 601-1, IEC 601-2-27 (ECG monitoring), and IEC 601-2-34 (invasive pressure monitoring). It explicitly states the device was "tested and certified to meet the above specifications by SEMKO."

The acceptance criteria mentioned are primarily related to electrical safety standards (e.g., leakage currents, dielectric strength, defibrillation protection) and functional aspects (e.g., isolation, high impedance inputs, filtering, amplification). However, there are no reported device performance metrics against quantitative acceptance criteria for clinical outcomes or diagnostic accuracy. There's no mention of a "study" in the sense of a clinical trial or performance evaluation involving human subjects to assess diagnostic capabilities.

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