CARDIOLOGY

Tempus ECG-Low-EF

Device Software Version: 2.1.0

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For additional information on device specifications, model training, and clinical performance testing, please refer to the Tempus ECG-Low EF Instructions for Use.
 
 

INDICATIONS FOR USE

Tempus ECG-Low EF is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 40 years of age or older at risk of heart failure. This population includes but is not limited to patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease.

Tempus ECG-Low EF only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-Low EF is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history.

A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of low LVEF. Patients receiving a negative result should continue to be evaluated in accordance with current medical practice standards using all available clinical information.

GENERAL WARNINGS AND PRECAUTIONS

• Tempus ECG-Low EF has not been evaluated in and should not be used for patients younger than 40 years of age.

• Tempus ECG-Low EF is not intended to replace other diagnostic tests.

• Results do not represent a diagnosis of low LVEF.

• Results do not rule-out low LVEF.

• Tempus ECG-Low EF should not be used on ECG recordings with paced rhythms.

• Tempus ECG-Low EF should not be used for patient monitoring.

• Tempus ECG-Low EF should not be used to initiate any therapy or treatment for low LVEF.

• Tempus ECG-Low EF should not be used for repeated testing of the same patient within a 12 month period.

INTERPRETATION OF RESULTS

[RESULT: LOW LVEF DETECTED]

Interpretation: This result indicates the device detected signs associated with low left ventricular ejection fraction (LVEF less than or equal to 40%) in the analyzed ECG tracing. This result does not represent a diagnosis of low LVEF.

Next Steps: In combination with other clinical information, consider further diagnostic evaluation to determine if low LVEF is present. Do not initiate any treatments based solely on this result.

[RESULT: LOW LVEF NOT DETECTED]

Interpretation: This result indicates the device did not detect signs associated with low left ventricular ejection fraction (LVEF less than or equal to 40%) in the analyzed ECG tracing. This result does not rule out current or future low LVEF.

Next Steps: Continue to evaluate for low LVEF in accordance with current medical practice standards.

[RESULT: UNCLASSIFIABLE]

Interpretation: The provided ECG tracing could not be analyzed due to characteristics of the ECG tracing and/or associated patient data.

Next Steps: Continue to evaluate for low LVEF in accordance with current medical practice standards.