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The Infinity M300 is intended for use with the ICS to monitor ECG and pulse oximetry on ambulatory and nonambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.

The Infinity M300 with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

The Infinity M300 is a wireless telemetry, patient-worn device with rechargeable lithium-ion battery which monitors ECG and SpO2 physiological data and features a color display, local alarm alerts and keypad interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis and SpO2 functions include pulse plethysmogram and pulse rate. Infinity M300 with TruST allows for 12-lead ECG monitoring with a reduced set of electrodes by deriving values for missing leads.

The provided text is a 510(k) summary from the FDA, detailing the premarket notification for the Draeger Medical Systems' Infinity M300 device. While it mentions "Verification Testing" and "Validation Testing" and refers to meeting criteria and supporting substantial equivalence, it does not provide the specific acceptance criteria, method, or results in a detailed, quantifiable manner that would allow for a comprehensive answer to your request.

The document is a regulatory communication, not a scientific study report. It states that "The results of Verification testing confirm the modified device continues to meet the criteria for substantial equivalence to the predicate device" and that "Validation test results support substantial equivalence to the predicate device." However, it does not disclose what those criteria are or the specific performance metrics achieved.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details on sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text. This information would typically be found in the full submission to the FDA, which is not included here.

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