FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The disposable ZOLL stat padz™ MwP Multi-function Electrodes are designed to provide both patient ECG monitoring and therapeutic capabilities in a single set of multi-function electrode pads. The ZOLL statepadz™ MwP Electrodes will connect to ZQLL Medical Corporation defibrillator products for use on adult patients. The electrode pads include two therapy electrodes with permanently attached lead wires that join together in a proprietary ZOLL connector. Commonly used ECG monitoring electrodes are embedded within the anterior electrode backing but are electrically isolated from the therapy region. This configuration is designed to eliminate the need for, and time delay associated with, attaching up to 3 separate ECG electrodes.

AI/ML Overview

The provided text describes a 510(k) summary for the ZOLL stat-padz™ MwP Multi-function Electrodes. It states that "The ZOLL Stat padz™ MwP Multi-function Electrode has been subjected to extensive performance testing to ensure that the device meets all of its functional requirements and performance specifications. Safety testing was performed to assure the device complies with applicable sections of recognized industry and safety standards." However, it does not provide specific details on the acceptance criteria, the actual results of the "extensive performance testing," or a study report with quantitative data.

Therefore, many of the requested details cannot be extracted from the given document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that "extensive performance testing" was done and that the device "meets all of its functional requirements and performance specifications," but it doesn't list the specific acceptance criteria or the reported performance data.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document mentions "performance testing" but does not specify sample sizes or data provenance.

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)

Not applicable / Cannot be provided. The device is a multi-function electrode, not an AI diagnostic tool requiring expert ground truth establishment in this context. The testing mentioned appears to be performance and safety testing against engineering specifications and industry standards, not a clinical study involving expert interpretation of data.

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

Not applicable / Cannot be provided. As above, this type of adjudication is typically for clinical studies involving human interpretation or AI output, not for the performance testing of an electrode against engineering specifications.

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 is not an AI diagnostic device. The basis for substantial equivalence is comparison to predicate devices, not a human reader study.

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

Not applicable. This describes an electrode, not an algorithm. The testing described is intrinsic device performance and safety.

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

Not applicable. For a device like an electrode, ground truth would refer to established engineering standards, electrical performance parameters, biocompatibility test results, and safety standards, rather than clinical ground truth obtained from experts or pathology.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As above, no training set is relevant here.

Summary of available information regarding compliance and testing:

Device Name: ZOLL stat-padz™ MwP Multi-function Electrodes
Purpose of Testing: To ensure the device meets all its functional requirements and performance specifications, and complies with applicable sections of recognized industry and safety standards.
Conclusion of Testing: Based on the results, the device demonstrated that its features and functions are substantially equivalent to indicated commercially distributed predicate devices with regard to performance, safety, and effectiveness.
Predicate Devices:
- ZOLL stat-padz™ Adult Multi-function Electrodes (K981802)
- Bio-Detek Tracerite ME40 SG ECG electrodes (K964213)
- Cardiotronics Systems, Inc. MODEL #918 Multi-Pads (K883375)

While the document confirms that testing occurred and met requirements for substantial equivalence, it does not provide the granular details of that testing, such as specific acceptance criteria or quantitative performance outcomes.

Summary

Regulation Number and Section

§ 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.