(141 days)
Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient.
Cardiac Science 9133 Defibrillation Electrodes are single use and intended to be used in conjunction with compatible automatic external defibrillators (AED) from Zoll or Physio-Control to monitor and deliver defibrillation energy to the patient, via brand-specific adapters. The brand-specific adapters are available for the AEDs specified in the product labeling.
The electrodes are intended for short term use (
The model 9131 and the 9133 Defibrillation Electrodes consists of a pair (2 each) of hydrogel polymeric self adhesive electrode pads of equal dimension. The outer dimension for each pad is 4.88in (12.4cm) by 4.88in (12.4 cm). Each electrode pad has a conductive hydrogel polymeric area of at least 50cm2 to comply with the AAMI DF-80 (AAMI DF-39) specifications. The total surface area of the two electrodes is greater or equal to 150cm2.
The electrodes pads are packaged in such a way that the two conductive hydrogel surfaces are in electrical contact. This feature enables the Cardiac Science AED to run diagnostic checks on the electrodes by checking the inter-electrode impedance when the electrode package is connected to and stored in the device.
The Cardiac Science 9133 defibrillation electrodes may be used in conjunction with adaptor cables that allow the electrodes to be used with compliant AEDs other than the Cardiac Science brands. These adaptor cables are provided as accessories to the Cardiac Science defibrillation electrodes.
The provided document is limited in the information it provides regarding acceptance criteria and study details. It refers to a 510(k) summary for defibrillation electrodes, focusing on substantial equivalence to a predicate device rather than a comprehensive de novo validation study with specific acceptance criteria and detailed performance metrics of an AI component.
However, based on the text provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Functional and Safety | Meets system, safety, functional, and performance specifications (AAMI DF-80 (AAMI DF-39) specifications | "All samples successfully passed." |
| Equivalence to Predicate | "do not raise any new questions regarding the safety or effectiveness as compared with the predicate device." | "substantially equivalent to the Defibrillation Electrode cleared in K971149 in terms of indications for use, features and functions." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states, "Representative samples of the electrodes were tested." It does not specify the exact number of samples used in the "Functional and Safety Testing."
- Data Provenance: Not specified. This document is a 510(k) summary, which typically reports on internal testing or testing required for regulatory submission. It does not provide details on the origin of the data beyond "representative samples." It is likely internal testing data.
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. The device (defibrillation electrodes) is a hardware component and accessory. Its "performance" is assessed through functional, electrical, and safety testing against engineering and regulatory standards (e.g., AAMI DF-80). It does not involve human interpretation of outputs that would require expert-established ground truth in the context of, for example, medical image analysis or diagnostic algorithms.
4. Adjudication Method for the Test Set
- Not Applicable. As noted above, this is a hardware device. No adjudication method for expert consensus is relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This document describes a 510(k) submission for defibrillation electrodes, which are passive medical devices. MRMC studies are typically performed for diagnostic devices (especially those involving AI or human interpretation) to assess improvements in human reader performance with computational assistance. This is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is hardware. It does not have an "algorithm only" component in the sense of AI. Its function is to deliver electrical energy and monitor. The "testing" referred to is about its physical and electrical properties.
7. The Type of Ground Truth Used
- Engineering and Regulatory Standards/Specifications. The "ground truth" for the device's performance is established by compliance with recognized industry standards (e.g., AAMI DF-80 (AAMI DF-39) specifications) and the device's own internal functional and safety specifications. For instance, impedance, adhesion, and energy delivery capabilities would be measured against predefined acceptable ranges derived from these standards.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of an AI/machine learning algorithm for this type of hardware device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set is involved.
Summary of Device and Study Type:
This 510(k) summary is for physical defibrillation electrodes. The "study" described is a series of functional and safety tests to demonstrate that the new models (9131 and 9133) meet established performance specifications and are substantially equivalent to a previously cleared predicate device (Survivalink-9130 Defibrillation Electrode, K971149). It is not a clinical efficacy study involving patient outcomes or a diagnostic AI validation study. The acceptance criteria are based on engineering and regulatory standards for defibrillation electrodes.
§ 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.