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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. Do not use the unit's AED function on patients under 8 years of age.

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).

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.

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 minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.

This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradvcardia might be expected, Suppression of tachycardia.

This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet), 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. SpCO monitoring is indicated for detecting carbon monoxide concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpMet monitoring is indicated for detecting oxidized hemoglobin concentration in arterial blood 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.

The ZOLL E Series® Defibrillator, reviewed and cleared by FDA under premarket notification K111594, is designed for all emergent care situations and provides multiparameter monitoring of patients in critical care and transport. The ZOLL E Series combines defibrillation, CPR feedback, ECG monitoring, noninvasive transcutaneous pacing, pulse oximetry (SpO2), end tidal CO2 (EtCO2), 12-Lead ECG monitoring, noninvasive blood pressure measurement and data printing and recording in a single instrument.

The previously cleared Shock Conversion Estimator (SCE), initially reviewed and cleared by the agency under K072923, utilizes Shock Predictive (SPI) as a parameter in the shock advisory algorithm. Shock Predictive Index number is also called "Amplitude Spectral Area (AmSA) value" of the ECG Waveform, developed by the Weil Institute of Critical Care Medicine. In the previously cleared version of the E-Series, when the E Series device is configured to enable the Shock Conversion Estimator (SCE) function, the software compares the calculated Shock Predictive Index (AmSA) against a userconfigurable threshold during shock advisory rhythm analysis. If the rhythm is shockable and the computed index is greater-than or equal-to the pre-configured threshold, the shock advisory algorithm will then issue a "Shock Advised" prompt to the user. If the Shock Predictive Index (AmSA) is less-than the threshold, the shock advisory algorithm will then issue a "Continue CPR" prompt to the user.

With the current application, we are proposing a software revision that will enable the E Series device to display the calculated Shock Predictive Index (AmSA) when used in manual mode with CPR defibrillation electrodes. After the trained rescuer has confirmed the ECG rhythm by manually analyzing the characteristics of the ECG waveform, the rescuer may utilize the displayed Shock Predictive Index (AmSA) value to perform the same function as the Rhythm Analysis Function Shock Conversion Estimator (SCE), reviewed and cleared by the agency under K072923.

This document describes a 510(k) premarket notification for a software revision to the ZOLL E Series Defibrillator, specifically enabling the display of the Shock Predictive Index (AmSA) in manual mode. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, many of the requested categories (like extensive clinical studies with specific sample sizes, ground truth adjudication, or MRMC studies) are explicitly stated as "Not Applicable" or implicitly not performed as the primary evidence relies on non-clinical software verification and validation, alongside literature support for the underlying AmSA concept.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly mentioned for specific clinical data in this submission. The "test set" primarily refers to software verification and system-level validation, rather than a traditional patient-based clinical study.
• Data Provenance: Not applicable for a separate test set as the primary evidence relies on non-clinical software testing and validation. The literature cited for AmSA would have their own 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 as the submission focuses on software verification and system-level validation for a software update, rather than a clinical study requiring expert-established ground truth on patient data for the new specific functionality (displaying AmSA). The underlying concept of AmSA and its use as a predictor of defibrillation success would have been established and validated in the scientific literature cited.

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

• Not applicable. The validation method for this software update is described as "software verification and system level validation," which typically involves engineering and quality assurance processes against predefined requirements, rather than clinical adjudication on patient cases.

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

• No MRMC comparative effectiveness study was done. Clinical evidence was explicitly stated as "N/A - Clinical evidence was not necessary to show substantial equivalence." The device provides information (AmSA) to the human operator, who then makes a decision; the study does not compare human performance with vs. without this specific display.

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

• The original Shock Conversion Estimator (SCE), cleared under K072923, was an "algorithm only" function that issued a "Shock Advised" or "Continue CPR" prompt. The current software revision allows the human operator to manually perform the function by interpreting the displayed AmSA value. Therefore, a standalone (algorithm only) performance study of this new manual interpretation functionality was not conducted, as the intent is human-in-the-loop.

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

• For the new functionality (displaying AmSA for manual interpretation), a clinical "ground truth" involving patient outcomes was not specifically established or documented in this submission. The ground truth for the concept of AmSA as a predictor of defibrillation success is derived from the scientific literature cited, which would have based findings on various methods including clinical outcomes. For the software itself, the "ground truth" during verification and validation would be adherence to software requirements and specifications.

8. The sample size for the training set

• Not applicable. This submission is for a software revision to display an already calculated parameter; it does not describe a new algorithm requiring a training set in the machine learning sense. The AmSA calculation itself was presumably developed and validated in prior efforts as referenced by existing predicate devices and literature.

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

• Not applicable, as there was no new training set for a new algorithm described in this submission.

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