CARDIOLOGY

Tempus ECG-AF

Unique Device Identifier (UDI): (01)00860011843603(10)310

Device Software Version: 3.1.0

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

INDICATIONS FOR USE

Tempus ECG-AF is intended for use to analyze recordings of 12-lead ECG devices and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. It is for use on resting 12-lead ECG recordings collected at a healthcare facility from patients:

• 65 years of age or older,
• without pre-existing or concurrent documentation of atrial fibrillation and/or atrial flutter,
• who do not have a pacemaker or implantable cardioverter defibrillator, and
• who did not have cardiac surgery within the preceding 30 days.

Performance of repeated testing of the same patient over time has not been evaluated and results SHOULD NOT be used for patient monitoring.

Tempus ECG-AF only analyzes ECG data. 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. Tempus ECG-AF is not for use in patients with a history of AF, unless the AF occurred after a cardiac surgery procedure and resolved within 30 days of the procedure. It is not for use to assess risk of occurrence of AF related to cardiac surgery.

Results do not describe a person’s overall risk of experiencing AF or serve as the sole basis for diagnosis of AF, and should not be used as the basis for treatment of AF.

Results are not intended to rule-out AF or the need for follow-up.

GENERAL WARNINGS AND PRECAUTIONS

Tempus ECG-AF has not been evaluated in and SHOULD NOT be used for:

• Patients younger than 65 years of age
• Patients with pre-existing or concurrent documentation of atrial fibrillation and/or atrial flutter
• Patients with a pacemaker or implantable cardioverter defibrillator
• Patients who have had cardiac surgery within the preceding 30 days

Tempus ECG-AF should not be used for patient monitoring (e.g., to track changes in patient status in response to medication or other therapy).

Results do not represent a diagnosis of AF.

Results should not be used as the basis for invasive monitoring, such as with an implantable loop recorder.

Results should not be used to direct any therapy against AF itself, including anticoagulation therapy.

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

INTERPRETATION OF RESULTS

[RESULT: INCREASED RISK]

Interpretation: This result indicates the patient is at increased risk of experiencing new onset AF within the 12 months following the analyzed ECG tracing. This result does not represent an AF diagnosis.

Next Steps: In combination with other clinical information, consider the need for follow-up to detect AF. Do not initiate any AF treatments, including use of anticoagulant medication, based on this result.

[RESULT: NO INCREASED RISK]

Interpretation: This result indicates the patient is not at increased risk of experiencing new onset AF within the 12 months following the analyzed ECG tracing. This result does not rule out current or future AF.

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

[RESULT: UNCLASSIFIABLE]

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

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