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The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient.

Specific indications for temporary cardiac pacing include, but are not limited to, the following:

• Complete heart block ●
• Sinus bradycardia ●
• Sick sinus syndrome ●
• Bradycardia with congestive heart failure ●
• Atrial and/or ventricular arrhythmias ●
• Cardiac arrest
• o Support, management, and evaluation of a patient prior to permanent pacemaker Implantation
• Support during permanent pacemaker replacement ●
• Cardiac complications during invasive or surgical procedures
• Support following cardiac surgery ●
• Acute myocardial infarction complicated by heart block ●
• Atrial tachyarrhythmias that require high-rate burst pacing for treatment ●

The Model 5392 EPG is a battery-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.

The provided document is a 510(k) premarket notification letter from the FDA to Medtronic, Inc. regarding a medical device, the Medtronic Model 5392 External Pulse Generator (EPG).

This document does not describe an AI/ML-based medical device or a study involving AI/ML performance.

Instead, it pertains to a traditional medical device (an external pacemaker) and its substantial equivalence to a predicate device. The "study" mentioned refers to bench testing to demonstrate that changes to the device's Instructions for Use (IFU), specifically regarding additional cleaners/disinfectants, do not compromise its design specifications or safety.

Therefore, I cannot extract the information required for an AI/ML-focused performance study because it is not present in the provided text. The questions about acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to this document.

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