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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.

The provided text describes documentation related to the FDA 510(k) clearance for the Medtronic Model 5392 External Pulse Generator (EPG). This document is a premarket notification for a medical device and therefore does not contain information about AI/ML device performance or clinical studies of AI-assisted human readers.

The clearance is for a change in the material of the patient connector in an existing device (predicate device K181973), not a new AI-powered device. Therefore, the questions related to AI acceptance criteria, sample sizes for AI training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable.

However, based on the information provided, here is what can be inferred about the device and its testing, though it does not involve AI:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The data from this testing showed that the devices could be manufactured with the modified patient connector material and continue to meet the current 5392 design specifications." and "The results of the above verification testing met the specified acceptance criteria and did not raise new safety or performance issues."

While specific numerical acceptance criteria and performance metrics are not detailed in this summary, the general acceptance criterion was that the modified device continued to meet the existing design specifications of the predicate Medtronic Model 5392 EPG.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text.
• Data Provenance: The studies performed were "bench tests." This indicates the testing was conducted in a laboratory setting, not with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the testing involved bench tests to verify engineering specifications, not clinical outcomes requiring expert interpretation of ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for bench testing.

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 device is not an AI/ML device, and no human-in-the-loop studies are mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hardware device (external pulse generator) and does not involve a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the bench tests would be the established engineering and performance specifications for the predicate device. Compliance with these specifications was verified.

8. The sample size for the training set:

Not applicable. The device is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

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