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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
• 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.

This FDA 510(k) premarket notification is for a Medtronic Model 5392 External Pulse Generator (EPG). This document establishes substantial equivalence to a previously cleared device, rather than proving performance against specific acceptance criteria in a clinical study for a new device. Therefore, many of the requested categories for a new device's performance study are not directly applicable or are not detailed in this document.

The core of this submission is to demonstrate that the modified Medtronic Model 5392 EPG is substantially equivalent to its predicate device (Medtronic Model 5392 EPG K132924), despite a minor design modification.

Here's the information presented, framed within your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are primarily based on demonstrating that the modified device performs equivalently to the predicate device, especially considering the minor "modified negative battery contact design." Performance is implicitly accepted if it aligns with the predicate and passes standard engineering verification.

2. Sample Size Used for the Test Set and the Data Provenance

This document describes bench testing for verification, not clinical studies with human participants. Therefore:

• Sample Size: Not explicitly stated in terms of patient numbers or clinical test cases. The testing was "regression bench testing to product level performance requirements." This implies engineering test units.
• Data Provenance: Not applicable. This refers to engineering bench test data, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth for clinical outcomes or diagnoses is not established in this type of submission focused on substantial equivalence through bench testing. The "truth" is whether the device meets its engineered specifications and performs consistently with the predicate.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical studies to resolve discrepancies among human readers/experts. This submission focuses on engineering verification.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a medical device for providing temporary cardiac pacing, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an external pulse generator, not an algorithm. Its operation inherently involves "trained personnel" in a "clinical environment where the patient is monitored continuously."

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence submission is based on engineering specifications and performance characteristics of the predicate device, as confirmed through bench testing. It's about demonstrating that the modified device's performance aligns with established engineering standards and the known performance of the predicate, not clinical outcomes derived from expert consensus, pathology, or long-term patient follow-up.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set for an algorithm, as this is a hardware device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an algorithm described in this document.

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