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The ADI Sensinel CPM (Cardiopulmonary Management) System is a wireless remote monitoring system intended for use by healthcare professionals for spot checking of physiological data in home and healthcare settings. This can include:

• ECG

• · Heart Auscultation Sounds
• · Skin Temperature
• · Thoracic Impedance (including Changes in Thoracic Impedance)
• · Respiration Rate and relative changes in Tidal Volume
  · Heart Rate
• Diastolic Heart Sounds Strength
• · Body Posture (including Tilt Angle)

Data are transmitted wirelessly from the ADI CPM (Cardiopulmonary Management) Wearable and Base Station for storage and analysis. The device is intended for use on general care adult patients who are 18 years of age or older to provide physiological information. The data from the ADI CPM (Cardiopulmonary Management) System Platform are intended for use by healthcare professional as an aid to diagnosis and treatment.

The ADI CPM System is intended to be used by patients at rest and not performing any activities or movements. This system is for spot checking and does not have continuous monitoring capability. The device does not produce alarms and is not intended for active patient monitoring (real-time).

The ADI CPM System in contraindicated for those patients with life threatening arrhythmias requiring immediate medical intervention.

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The provided FDA 510(k) clearance letter and Indications for Use document for the Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) do not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

This document primarily states that the device has been found substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements and indications for use. It does not include performance data, study designs, sample sizes, ground truth methodologies, or expert qualifications.

To answer your request, the following information would typically be found in the 510(k) submission's technical documentation (e.g., performance testing details, clinical study reports), which is not included in the provided text.

Therefore, I cannot extract the information required for the detailed answer as it is not present in the given text.

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