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CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia.
♦ CardioServ is intended to be used by trained operators
♦ CardioServ is designed for external and internal defibrillation (including cardioversion)
♦ CardioServ is capable of monitoring the heart rate with adjustable alarm limits.
♦ CardioServ is capable of monitoring the saturation of O₂ with adjustable alarm limits.
The intended use of CardioServ is identical to the intended use of the predicate devices.

CardioServ S is a portable defibrillator with ECG monitor, built-in recorder, and the capability of monitoring the saturation of O₂ with adjustable alarm limits.

The provided text describes a medical device, the "CardioServ S," which is a portable defibrillator with ECG monitor and O₂ saturation monitoring capabilities. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or details related to an AI/machine learning component.

The "Performance" section explicitly states that "CardioServ complies with the voluntary standards ANSI/AAMI DF2-1989, ANSI/AAMI ES1-1993. IEC 606-1. IEC 601-1-1, IEC 601-2-4, and prEN865." It also mentions "Requirements specification reviews, code inspections, software and hardware testing, safety testing, environmental testing, final validation testing by an independent test group, field tests" as quality assurance measures. The conclusion is that "CardioServ is as safe, as effective, and performs as well as the predicate devices CardioServ SCP 910 and NELLCOR Escort 300 Series."

Therefore, based on the provided text, I cannot fulfill your request for the following information:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on regulatory compliance through adherence to voluntary standards and comparison to predicate devices, rather than a performance study with specific metrics and acceptance criteria as described in your request, which are typically associated with AI/ML-driven medical devices.

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