(200 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 ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response to defibrillate victims of cardiac arrest.
The ZOLL AED Plus is a lightweight, portable, battery powered semi-automatic external defibrillator that uses voice prompts and visual icons to quide a user through a cardiac The device utilizes the ZOLL Rectilinear Bi-Phasic defibrillation arrest rescue. waveform. The device is designed to be used by trained emergency responders for the treatment of cardiac arrest.
When connected with ZOLL AED Plus defibrillation electrodes to a patient, the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or not shockable. If the device detects a shockable rhythm, the device charges the capacitor, enables the treatment button and issues the audio warning "Don't Touch Patient, Press Treatment Button". The user can then press the treatment button to deliver defibrillation therapy to the patient. If the patient is not responsive to treatment, additional shocks may be advised and administered after automatically repeated analyses of the patient's heart rhythm.
The ZOLL AED Plus is lightweight. It can easily be transported to any rescue site. It is designed to hang on the wall in an area where it is easily accessible and ready to use at a moment's notice. The device automatically performs a periodic self-test and continually indicates its state of readiness to the user.
When the ZOLL AED Plus is used in conjunction with the ZOLL AED Plus Pediatric Electrodes the device can be used on patients less than 8 years of age. Labeling and packaging of the electrodes is designed to promote a clear visual distinction between adult and pediatric electrodes.
The ZOLL AED Plus device is a semi-automatic external defibrillator designed for use by trained emergency responders. The provided documentation primarily addresses substantial equivalence for market clearance rather than detailed performance reporting from specific clinical studies to establish acceptance criteria. Therefore, much of the requested information about acceptance criteria and study particulars for device performance as typically understood for AI/algorithm-driven devices (accuracy, sensitivity, specificity, etc.) is not explicitly available in the provided text.
However, based on the information provided, here's a breakdown of what can be extracted and what is not explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on a declaration of substantial equivalence based on safety and functional performance meeting established standards, rather than providing specific numerical performance metrics (like sensitivity/specificity for rhythm classification against a ground truth).
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety Standards Compliance | EN60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety) | Meets applicable sections of the standard. |
| EN60601-1-2 (Medical Electrical Equipment Part 1: General Requirements for Safety; Electromagnetic Compatibility) | Meets applicable sections of the standard. | |
| IEC 601-2-4 (Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator-Monitors) | Meets applicable sections of the standard. | |
| AAMI DF39 (AED and Remote Control Defibrillators) | Meets applicable sections of the standard. | |
| **Functional Requirements/ | Rhythm classification algorithm Performance Specifications** | "Rhythm classification algorithm performance testing on a pediatric database." |
| Electrode Performance | Electrode performance testing | Testing was performed (no specific metrics provided). |
| Defibrillation Energy Dosing | Animal testing of defibrillation energy dosing | Testing was performed (no specific metrics provided). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for any specific test set, including the "pediatric database" used for rhythm classification.
- Data Provenance: Not specified (e.g., country of origin). The terms "retrospective" or "prospective" are not used.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The document mentions "rhythm classification algorithm performance testing on a pediatric database" but does not describe how the ground truth for that database was established or by whom.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not discussed or reported in the provided text. The document focuses on the device's functional and safety performance relative to standards and its predicate device. This type of study (human readers with/without AI assistance) is typically relevant for interpretative AI devices, which this AED system is not described as in the sense of directly assisting human interpretation of complex medical images or data beyond basic rhythm analysis in an emergency.
6. Standalone (Algorithm Only) Performance
A standalone performance evaluation was implied for the "rhythm classification algorithm performance testing on a pediatric database." However, specific metrics (e.g., sensitivity, specificity, PPV, NPV) from this standalone performance are not reported in the document. The document states that final testing included "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications," but the details of these are not provided.
7. Type of Ground Truth Used
The type of ground truth used for the "pediatric database" rhythm classification algorithm testing is not explicitly stated. For ECG rhythm analysis, ground truth is typically established by expert cardiologists reviewing the ECG tracings. Without explicit mention, it's assumed to be expert consensus, but this is not confirmed.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. The focus is on the device's final performance and adherence to standards for substantial equivalence.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not mentioned, the method for establishing its ground truth is also 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.