(85 days)
The Model 53401 SC EPG is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylatic, or diagnostic purposes.
Specification indications for temporary cardiac pacing include, but are not limited to, the following indications:
- · Complete heart block
- · Sinus bradycardia
- · Sick Sinus Syndrome
- · Bradycardia with congestive heart failure
- · Atrial and/or ventricular arrhythmias
- · Cardiac arrest
- · Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation
- · Support during permanent pacemaker replacement
- · Cardiac complications during invasive or surgical procedures
- · Temporary support of a patient following cardiac surgery
- · Acute myocardial infarction complicated by heart block
- · High-rate burst pacing for the treatment of supraventricular tachyarrhythmias.
The Medtronic Temporary External Pacemaker Model 53401 (hereafter simply referred to as the 53401; or the 53401 SC EPG where SC EPG stands for Single Chamber External Pulse Generator) is a battery-powered, single chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The Model 53408 is an optional disposable protective cover to reduce accidental activation of the controls of the 53401 SC EPG.
The provided FDA 510(k) summary for the Medtronic Temporary External Pacemaker Model 53401 does not include acceptance criteria or a study that clearly demonstrates the device meets specific performance metrics in the way a clinical study would for an AI/ML device.
This document describes a medical device, specifically an external pacemaker, not an AI/ML powered diagnostic device. Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and type of ground truth) is not applicable or present in this submission.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with various medical device standards.
Here's an analysis of the provided text in the context of the requested information, with specific notes on why certain categories are not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria with corresponding device performance metrics in the format typically seen for AI/ML performance. Instead, it states that "Design verification and validation was performed to demonstrate that the Medtronic 53401 SC EPG and its accessories meet established performance criteria." It refers to compliance with various standards.
Implicit Acceptance Criteria (based on standards compliance):
| Acceptance Criteria Category (Derived) | Stated Performance / Compliance |
|---|---|
| Safety (Electrical/Mechanical) | Complies with IEC 60601-1: 2012 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2: 2014; UL Test Reports, NW EMC Reports, and Product Verification |
| Basic Safety & Essential Performance (External Pacemakers) | Complies with IEC 60601-2-31: 2011 |
| Usability/Human Factors | Complies with IEC 60601-1-6:2013, EN 62366:2014, ANSI/AAMI HE75: 2013; Human Factors Evaluation |
| Biocompatibility | Complies with ISO 10993-1:2013; Biocompatibility Testing |
| Software Life-cycle Processes/Firmware | Complies with IEC EN 62304: 2006/AC:2008; Firmware (Embedded Software) Verification and Validation |
| Packaging Integrity | Complies with ASTM D4169: 2008; Packaging Testing |
| Intended Use & Technological Characteristics | Demonstrated to be "substantially equivalent" to predicate device (Medtronic Model 5392) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as the submission describes non-clinical bench testing and human factors evaluation of a physical device, not an AI/ML algorithm processing medical data. There is no "test set" in the sense of a dataset of medical cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. Ground truth for medical data is not relevant to the testing described for this physical pacemaker device. Human factors evaluations would involve users, but they are assessing usability, not establishing ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no "test set" of medical cases requiring adjudication.
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
This is not applicable. MRMC studies are used for diagnostic algorithms involving human readers interpreting outputs. This document is for a physical pacemaker device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical device, not an algorithm. Performance testing (e.g., electrical output, battery life, physical durability) would be "standalone" in the sense that the device is tested by itself, but this is a different context than standalone AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. Ground truth in the context of diagnostic accuracy is not relevant here. The ground truth for device performance would be the specifications and requirements defined by the manufacturer and relevant medical device standards.
8. The sample size for the training set
This is not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable.
Summary of the Study:
The "study" presented here is a design verification and validation process for a traditional medical device (an external pacemaker). It primarily relies on non-clinical bench testing and human factors evaluation testing to demonstrate compliance with various international and national standards (e.g., IEC 60601 series, ISO 10993, ASTM D4169, ANSI/AAMI HE75). The key "proof" of meeting acceptance criteria is the documentation of compliance with these established safety, performance, usability, and manufacturing standards for medical devices. The ultimate goal of this submission is to establish substantial equivalence to an existing legally marketed predicate device (Medtronic Model 5392).
§ 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.