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The Commander II device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.

The Commander II is an automated device that connects to the user's telephone system at home. It has a display that asks the user health related questions and has inputs for devices such as weight scales, blood pressure meters, and other vital sign measurement devices.

The provided text is a 510(k) premarket notification for the Commander II device, which is an automated system for collecting and transmitting patient health data. This document does not contain the detailed study information or acceptance criteria typically found for studies evaluating the performance of a medical device against specific metrics, especially not for AI-enabled devices or clinical efficacy studies.

Instead, the document focuses on:

• Device Description and Intended Use: Explaining what the Commander II is and what it does.
• Substantial Equivalence to a Predicate Device: Arguing that the Commander II is similar enough to an already approved device (Home Care Monitoring System, AvidCare Corp., K010029) to be cleared for market.
• Safety and Functional Testing: Mentioning compliance with general electrical safety, emissions, and telephone network standards (EN60601-1-2, EN61000-3-2, FCC Part 68, UL/C-UL). It states "Verification and validation testing was conducted to establish performance and reliability characteristics of the device," but does not provide details of these tests, their acceptance criteria, or their results in a quantifiable manner.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, ground truth establishment, or specific study details like MRMC or standalone performance, as this information is not present in the provided text.

The document essentially states that the device was tested to general safety and operational standards and that these tests, along with the low-risk device type, led Cardiocom to conclude there are "no significant concerns about safety and effectiveness." It does not provide the kind of performance data (e.g., sensitivity, specificity, accuracy for a specific task) that would typically be associated with acceptance criteria for a diagnostic or AI-powered medical device.

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