(192 days)
Defibrillator Function: The E Series products contain a dc defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team. Intended Use - Manual Operation: Use of the E Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In manual mode, the E Series unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate. The advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed). Intended Use — Semiautomatic Operation (AED): The E Series AED unit is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation.
External Pacemaker (Pacer Version Only): Intended Use - Pacemaker: This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia. Pediatric Pacing: Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL. pediatric MFE Pads.
Monitor: Intended Use - Multi-parameter Monitoring: This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP). ECG monitoring is performed by connecting the patient to the 3 or 5 lead patient cable, MFE Pads, or through the paddles. SpO2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients. 12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction or other cardiac arrhythmias. NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.
Intended Use -- CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients.
The ZOLL E Series External Defibrillator is indicated for the defibrillation, Noninyasive Transcutaneous Pacing and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, end tidal CO2, 12-Lead ECG monitoring, non-invasive blood pressure measurement, CPR performance and data printing and recording for resting patients in critical care and transport. The device is light weight and easy to carry for transport. The device is capable of providing Basic Life-Saving (BLS) personnel the option of analyzing a patient's ECG signal via the Advisory feature on the device. The Advisory Algorithm will determine if the acquired heart rhythm is shockable or non-shockable and will prompt the end-user to provide therapy in the event of a shock advised determination. The user will be prompted to perform Cardiopulmonary Resuscitation in the event that the Analyze feature determines that CPR compressions are more beneficial to the victim.
The provided document does not contain explicit acceptance criteria tables or detailed study results for the Advisory Algorithm within the ZOLL E Series Defibrillator. While it states that "Performance and safety testing of the ZOLL E Series Defibrillator demonstrates that its features, functions and incorporated interpretive algorithm are that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness," it relies on substantial equivalence to the Philips Medical Systems HeartStart FR2+ AED (K051632) rather than presenting a standalone study with specific metrics for the Advisory Algorithm's performance.
Therefore, many of the requested details about acceptance criteria and study particulars cannot be directly extracted from the provided text.
However, based on the context of an Automated External Defibrillator (AED) and its advisory function, we can infer common performance metrics and the type of acceptance criteria that would typically be expected, even if not explicitly stated with numerical targets.
Inferred Acceptance Criteria and Reported Device Performance (Based on AED Standards and Substantial Equivalence):
Given that the device's Advisory Algorithm determines if a rhythm is shockable or non-shockable, the key performance metrics would revolve around its accuracy in this determination.
| Acceptance Criterion (Inferred) | Reported Device Performance (Inferred from Substantial Equivalence and General Statements) |
|---|---|
| Sensitivity (Shockable Rhythm Detection) | |
| Ability to correctly identify shockable rhythms (e.g., ventricular fibrillation, rapid ventricular tachycardia) and advise a shock. | "Performance and safety testing... demonstrates that its features, functions and incorporated interpretive algorithm are that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness." (Implies meeting or comparing favorably to predicate's known sensitivity) |
| Specificity (Non-Shockable Rhythm Discrimination) | |
| Ability to correctly identify non-shockable rhythms and advise no shock. | "Performance and safety testing... demonstrates that its features, functions and incorporated interpretive algorithm are that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness." (Implies meeting or comparing favorably to predicate's known specificity) |
| Time to Analysis/Shock Advisory (If applicable) | Not explicitly stated. |
| CPR prompt accuracy/timing (for advisory on CPR) | Not explicitly stated for the advisory algorithm's accuracy, but the CPR monitoring function prompts based on AHA/ERC guidelines. |
Detailed Study Information (Based on Available Text):
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. Given the context of a 510(k) submission, it's likely that a dataset of previously recorded ECGs (retrospective) would have been used for algorithm testing, but this is not explicitly stated.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. For AED rhythm analysis, ground truth is typically established by expert cardiologists or emergency physicians, but details are not provided.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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 specified. The document focuses on the AED's standalone advisory function, not an AI-assisted human reading scenario. The device prompts the end-user based on its analysis, but there's no mention of a study comparing human performance with and without this specific AI's assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Advisory Algorithm will determine if the acquired heart rhythm is shockable or non-shockable and will prompt the end-user." This describes the algorithm's standalone function (without immediate human intervention in the analysis process itself, though a human acts on the advice). The "Performance Testing" section states this testing was done.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For AED rhythm analysis, the ground truth for ECG interpretation (e.g., whether a rhythm is Ventricular Fibrillation, asystole, etc.) is typically established by expert consensus of cardiologists/electrophysiologists analyzing the ECG waveforms.
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The sample size for the training set:
- Not specified. The document describes the "Advisory Algorithm" but does not detail its development or training process.
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How the ground truth for the training set was established:
- Not specified. Assuming a similar methodology to the test set, it would likely involve expert interpretation of ECGs, but this is not confirmed.
§ 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.