(29 days)
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.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Device continues to meet current design specifications | Modified device met specified acceptance criteria; no new safety/performance issues |
| Device maintains safe and effective use | Demonstrated safe and effective use with modified connector material |
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.
§ 870.3600 External pacemaker pulse generator.
(a)
Identification. An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.
(2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (
i.e., battery power, AC mains connections, or both).(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;
(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;
(iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (
e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.
(4) Appropriate software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;
(ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;
(iii) The labeling must list all pacing modes available in the device;
(iv) Labeling must include a detailed description of any special capabilities (
e.g., overdrive pacing or automatic mode switching); and(v) Appropriate electromagnetic compatibility information must be included.