(88 days)
The Multifunctional Electrodes, Models 9640 and 9650 are single use and intended to be used for defibrillation, synchronized cardioversion, ECG monitoring, and external pacing.
The Multifunctional Electrodes consist of a pair of single-use, hydrogel polymeric selfadhesive electrode pads of equal dimension intended to be used for defibrillation, synchronized cardioversion, ECG monitoring and external pacing. The Multifunctional Electrodes are for use with the Powerheart® Cardiac Rhythm Module and the Powerheart® Automatic External Cardiac Defibrillator (AECD). The electrodes are packaged in a pouch to prevent the gel from drying out. The Model 9640 contains an additional small right leg drive (RLD) electrode on the sternum pad. The RLD electrode is used to eliminate the voltage potential between the patient and defibrillator's ground reference. Inside each electrode connector is an electrode ID chip. The ID chip allows the defibrillator to read the electrode specific information contained in the ID chip.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardiac Science Multifunctional Electrodes:
Please note that the provided document is a 510(k) summary for a medical device. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than presenting extensive, detailed clinical trials with specific acceptance criteria, statistical power calculations, or human reader studies common in AI/software device submissions. Therefore, many of the requested points below may not be fully answerable based solely on this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Defibrillation: Meet applicable requirements from ANSI/AAMI DF-2 and DF-39. | The Multifunctional Electrodes were found to perform as intended in accordance with industry standards ANSI/AAMI DF-2 and ANSI/AAMI DF-39. This implies they met the electrical, mechanical, and safety requirements specified in these standards for defibrillation electrodes. |
| ECG Monitoring: Meet applicable requirements from ANSI/AAMI EC-12. | The Multifunctional Electrodes were found to perform as intended in accordance with industry standard ANSI/AAMI EC-12. This implies they met the performance requirements for ECG monitoring electrodes. |
| Pacing: Meet applicable requirements from relevant standards (implied by overall performance for intended use). | The Multifunctional Electrodes were found to perform as intended. Specific pacing performance criteria are not explicitly detailed but are covered by the general statement of meeting intended use and implied by the industry standards for multi-functional electrodes. |
| Synchronized Cardioversion: Meet applicable requirements from relevant standards (implied by overall performance for intended use). | The Multifunctional Electrodes were found to perform as intended. Specific cardioversion performance criteria are not explicitly detailed but are covered by the general statement of meeting intended use and implied by the industry standards for multi-functional electrodes. |
| Biocompatibility: Meet requirements for components in contact with patient's skin. | Biocompatibility assessments were conducted on the components that come into contact with the patient's skin, and the electrodes were found to perform as intended. This implies the device met established biocompatibility standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The performance testing is described generally as "conducted to verify that the Multifunctional Electrodes meet the applicable requirements."
- Data Provenance: Not specified. The testing described is likely laboratory-based and in-vitro, referring to the physical performance of the electrodes against engineering standards. It is not clinical data provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of performance testing described. The "ground truth" for this device's performance would be the specifications and requirements outlined in the referenced ANSI/AAMI industry standards (DF-2, DF-39, EC-12), not expert clinical consensus on patient data.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or clinical adjudication. The performance is assessed against predefined engineering and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with AI vs. without AI
No, an MRMC comparative effectiveness study was not done, and this device is not an AI-powered diagnostic device, but rather a physical electrode. Therefore, this section is not applicable.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. The device is a physical electrode system. Its "standalone performance" refers to its ability to meet the defined electrical, mechanical, and biocompatibility standards independently, which was indeed evaluated as described in Section 16.8.
7. The Type of Ground Truth Used
The ground truth used for performance validation was industry standards and specifications. Specifically, the device's performance was compared against the requirements stipulated in:
- ANSI/AAMI DF-2 (Defibrillator Electrodes)
- ANSI/AAMI DF-39 (Automatic External Defibrillators and Associated Defibrillator Electrodes)
- ANSI/AAMI EC-12 (Disposable ECG Electrodes)
- Biocompatibility standards (implied, not explicitly named)
8. The Sample Size for the Training Set
Not applicable. This device is a physical electrode, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.