(249 days)
The Sensinel™ CPM 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 (Obtained from left chest area)
- 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 Sensinel™ CPM Wearable and Base Station for storage and analysis. The CPM Wearable is intended for use on general care adult patients 18 years of age or older to provide physiological information. The data from the CPM System is intended for use by healthcare professionals as an aid to diagnosis and treatment.
The 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 CPM Wearable does not produce alarms and is not intended for active patient monitoring (in real-time).
The Sensinel™ CPM System is contraindicated for those patients with life threatening arrhythmias requiring immediate medical intervention.
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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as requested in your prompt.
The document is an FDA 510(k) clearance letter for the "Sensinel™ CPM System," stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the indications for use, regulatory class, and general compliance requirements.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample size, data provenance, number of experts, adjudication methods, or the type of ground truth used for any test set or training set.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
To answer your questions fully, I would need a detailed study report or a section of the 510(k) submission that specifically addresses the performance testing and validation of the device against predefined acceptance criteria.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).