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Defibrillator Function: The E Series ALS 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 ALS 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 ALS 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 ALS 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.

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 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.

Intended Use - Pacemaker: 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 bradvcardia 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. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.

Monitor Intended-Use Multi-parameter Monitoring: 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 predicate ZOLL E Series External Defibrillator/Monitor reviewed and cleared by the FDA (K111594 and K092598) is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. It combines the function of a manual defibrillator, noninvasive transcutaneous pacer. ECG monitor, pulse oximeter, end tidal CO2 monitor. 12-Lead EGG monitor, non-invasive blood pressure monitor and CPR performance monitor along with data printing and recording capabilities. Functions are offered as options, and functions can be configured during manufacturing to meet the needs of a particular application. Through a manufacturing configuration option that is already available in the device's software and currently offered for distribution (reviewed and cleared by FDA under K111594), the ECG rhythm analysis (advisory) option can be disabled during the manufacturing of the device. This creates a manual-only/ non-AED configuration of the device which is marketed as E Series ALS and intended to be used by ACLS qualified personnel. On the hardware side, the front panel that is offered with this configuration does not include the analyze button that is used to initiate ECG rhythm analysis.

This document is a 510(k) premarket notification for the "Zoll E Series ALS" device. The manufacturer is seeking clearance for a specific configuration of an existing device (Zoll E Series cleared under K111594 and K092598) as a standalone Class II device. The key aspect is that this new configuration, E Series ALS, disables the ECG rhythm analysis (advisory) option and removes the "analyze" button, making it a manual-only/non-AED configuration.

Based on the provided text, there are no specific acceptance criteria or a dedicated study described to demonstrate the device meets acceptance criteria as typically found for new device functionality or performance claims. The fundamental argument for clearance in this submission is that no new device functionality or performance is being introduced.

Here's an analysis based on the structure of your request:

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

   • Acceptance Criteria: Not explicitly stated as new criteria. The device is leveraging the performance and safety established for its predicate device (Zoll E Series, K111594 and K092598). The central "acceptance" is that the removal of the AED/advisory functionality does not introduce new risks or modify existing performance.
   • Reported Device Performance: No new performance metrics are reported in this particular submission. The device's performance characteristics (defibrillation energy delivery, pacing, monitoring vital signs, CPR feedback) are presumed to be the same as the cleared predicate device.

2. Sample size used for the test set and the data provenance

   • No new test set was used for this submission. The submission explicitly states: "No new product or software requirements were introduced... and therefore, no additional design or software verification or validation testing was necessary." This implies reliance on the testing performed for the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • Not applicable. No new test set requiring expert ground truth establishment for novel functionality was used in this submission.

4. Adjudication method for the test set

   • Not applicable. No new test set.

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 device is not an AI-assisted diagnostic tool, and no MRMC study was conducted or referenced in this document.

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

   • Not applicable. This device is a medical device with various monitoring and therapeutic functions, not an algorithm. The 510(k) submission itself is for a "standalone Class II clearance" in the regulatory sense, but not for a standalone algorithm performance study. In fact, the removal of an "algorithm-like" function (ECG rhythm analysis/advisory) is a key aspect of this submission.

7. The type of ground truth used

   • Not applicable for this submission. For the predicate device, the ground truth would have been established through a combination of engineering testing, clinical studies, and compliance with performance standards typical for defibrillators, pacemakers, and patient monitors.

8. The sample size for the training set

   • Not applicable. This submission does not involve a machine learning algorithm or a specific training set.

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

   • Not applicable.

Summary of the document's argument regarding acceptance criteria and testing:

The core of this 510(k) submission for the Zoll E Series ALS is that it is a configuration of an already cleared device (Zoll E Series, K111594). The key modification is the disabling of the ECG rhythm analysis (advisory) option and the removal of the "analyze" button, effectively creating a manual-only defibrillator for use by ACLS qualified personnel.

The manufacturer explicitly states:

• "No software modifications were needed to produce the E Series ALS..."
• "The capability to configure the device as E Series ALS during the manufacturing process by disabling the ECG rhythm analysis already existed in the predicate device cleared under K111594."
• "No new product or software requirements were introduced... and therefore, no additional design or software verification or validation testing was necessary."
• "Removal of the 'Analyze' button from the front panel... did not introduce any new risks, or raise any usability issues or concerns..."

Therefore, the "acceptance criteria" discussed in this document are implicitly the safety and effectiveness criteria established and met by the predicate device (K111594/K092598). The "study that proves the device meets the acceptance criteria" is essentially the original testing and clearance data for the predicate device, combined with the argument that removing a feature does not negatively impact the device's substantial equivalence or safety profile. The FDA's issuance of the clearance letter (Pages 0-1) indicates their agreement with this assessment for regulatory purposes.

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