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The Cardiac Science CareCenter MD is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult and pediatric populations. The device is designed to acquire, display, process, record, analyze and output 12 lead ECG data during periods of physiological stress, induced through exercise or pharmacological means or during resting ECG testing. In addition, the CareCenter MD provides interfaces for acquiring physiological data from ancillary devices (such as spirometry and blood pressure) and records ECG in real time with and without arrhythmia detection.

The system provides automatic interpretation of resting ECG on adult populations. No automatic interpretation of resting ECGs is provided for pediatric populations. Interpretive statements should be overviewed and approved by trained physicians.

The CareCenter MD may provide interfaces for the control of external devices such as a treadmill or an ergometer, and for communicating with centralized computer systems via a network. The device is intended to provide non-diagnostic patient data management functions as both a selfcontained, stand-alone application and by interfacing with Electronic Medical Records systems.

The device is not intended to be used as a vital signs or long term physiological monitor. The CareCenter MD is not intended to be used as a transport device.

The Cardiac Science CareCenter MD is a medical device system comprised of software and hardware acquisition modules used for acquisition, evaluation and administration of 12-channel electrocardiograph (ECG) from patients both at rest and during exercise (stress testing). The Cardiac Science CareCenter MD software is installed on a customer provided personal computer (PC).

CareCenter MD is a diagnostic device capable of ECG monitoring; ST analysis and arrhythmia detection; generation, review, and storage of stress reports; interpretation of resting ECG reports; and treadmill or ergometer control. Approved serial devices such as non-invasive blood pressure measurement are supported by CareCenter MD for stress testing.

The provided text for the CareCenter MD (Electrocardiograph) does not contain a study that proves the device meets specific acceptance criteria with reported performance metrics.

Instead, the document primarily focuses on establishing substantial equivalence to predicate devices based on shared technological characteristics and intended use. It confirms that "Device components underwent safety and bench testing on both hardware and software and demonstrated acceptable functional and performance results," but it does not elaborate on what those "acceptable functional and performance results" were or how they were measured against specific criteria.

Therefore, I cannot populate the table with acceptance criteria and reported device performance from the provided text. Similarly, I cannot provide details about sample sizes, data provenance, ground truth establishment, or study types (MRMC, standalone) because such information is not present in the given document.

The document mainly serves as a 510(k) summary for an electrocardiograph, emphasizing its similarity to existing devices for regulatory approval, rather than detailing a specific performance study with quantitative results against acceptance criteria.

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