(260 days)
Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by:
- · Unconsciousness and
- · Absence of normal breathing and
- · Absence of a pulse or signs of circulation
When a victim is less than 8 years of age, or weighs less than 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
The device is a lightweight, portable, battery-powered semi-automatic external defibrillator that uses voice prompts and visual icons to guide a user through a cardiac arrest rescue. The device utilized the ZOLL Rectilinear Bi-Phasic defibrillation waveform. The device is designed to be used by trained responders for the treatment of cardiac arrest.
When connected with ZOLL AED Plus defibrillation electrodes to a patient, the predicate device will analyze the electrocardiographic (ECG) ihythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a nonshockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that measures the depth of CPR compressions. This information is used by the device to provide feedback to the user and encourage the user to administer CPR in compliance with the 2010 American Heart Association (AHA) Guidelines. If the device detects a shockable rhythm, the semiautomatic configuration of the device charges the capacitor, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. The user would then press the treatment (shock) button to deliver the defibrillation shock to the patient. The new fully automatic configuration would deliver the shock to the patient without the need for the user (rescuer) to press the shock button.
The ZOLL Fully Automatic AED Plus is a semi-automatic external defibrillator that has been updated to deliver a shock automatically without the user pressing a button, following appropriate prompts and a warning tone.
Here's an analysis of the provided information concerning acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or specific performance metrics for the new fully automatic feature of the ZOLL Fully Automatic AED Plus. Instead, it relies on a comparison to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K110154) in: | The new device's features and functions are "substantially equivalent" to the predicate ZOLL AED Plus (K110154). |
| - Features and Functions | All other functions and Indications for Use have remained "unchanged." The proposed change is implemented through software. |
| - Technological Characteristics | Technological characteristics are "substantially equivalent" to the predicate. |
| - Performance | "Extensive performance testing ensures that the ZOLL Fully Automatic AED Plus performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications." |
| - Safety | "Safety testing assures that the device complies with applicable sections of recognized industry and safety standards." |
| - Effectiveness | Performance, safety, and effectiveness are substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for any test sets related to the fully automatic feature. It broadly mentions "Extensive performance testing" and "Safety testing." There is no information on data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study described does not appear to involve human expert ground truth determination in the conventional sense for algorithmic performance, but rather focuses on functional and safety equivalency.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is present. The focus is on the device's functional equivalence and safety, not on human reader improvement with or without AI assistance. The device is an automated external defibrillator, where the "AI" (algorithm) is designed to act on its own, not to assist human readers in interpreting information.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
The study described primarily assesses the standalone performance of the algorithm in the context of its new fully automatic shock delivery. The product is an "Automatic External Defibrillator," implying standalone algorithmic function. The document states:
- "When a shockable rhythm has been detected defibrillation energy is delivered by the device without the need for the user (rescuer) to depress the treatment (shock) button following a sequence of appropriate prompts and a warning tone."
- "All other functions of the device and its Indications for Use have remained unchanged."
This indicates that the core rhythm analysis and shock advisory/delivery mechanism, which is the heart of the algorithm's standalone function, is the primary subject of evaluation for the change.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance testing. However, given it's an AED, the ground truth for rhythm analysis (shockable vs. non-shockable) would typically be established based on:
- Electrophysiological standards (e.g., specific ECG waveform characteristics recognized as ventricular fibrillation or ventricular tachycardia).
- Potentially, expert ECG review.
For the fully automatic shock delivery, the ground truth would be whether a shockable rhythm was correctly identified according to established criteria, and whether the device then proceeded to deliver the shock as designed.
8. Sample Size for the Training Set
This information is not provided. The document focuses on regulatory submission and substantial equivalence, not the details of algorithm development or training data.
9. How the Ground Truth for the Training Set Was Established
This information is not provided.
§ 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.