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The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series. The X Series is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The X Series unit can be used on pediatric patients, (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

Manual Defibrillation: Use of the devicein the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, 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. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

ECG Monitoring: The device is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

External Transcutaneous Pacing: This product can 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.

Non-Invasive Blood Pressure Monitoring: The device is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user.

Temperature Monitoring: The device is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.

Respiration Monitoring: The device is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor.

CO2 Monitoring: The device is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate.

Invasive Pressure Monitoring: The device is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply.

Semiautomatic Operation (AED): The device 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 as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.

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.

SpO2 Monitoring: The X Series pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet). The pulse CO-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospital-type facilities, or in mobile environments.

12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data.

The ZOLL Propaq MD device is being revised with additional features and optional modules. This configuration of the device will be marketed as the ZOLL X Series. The X Series is a light weight, portable device designed to be used by trained medical personnel who are familiar with basic monitoring, vital sign assessment and emergency cardiac care. As in its previous configuration, the X Series combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, noninvasive blood pressure monitor, invasive pressure monitor, respiration rate monitor and temperature monitor. Functions are offered as options and functions can be configured to meet the needs of a particular application. Additionally, the proposed configuration (ZOLL X Series) adds the following features: Semi-automatic external defibrillation function (AED) Mode, CPR rate and depth monitoring, See-Thru CPR ECG filtering, Inovise Audicor 12-Lead ECG Interpretive Algorithm, ECG Life Threatening Alarms, Masimo Rainbow MX3 Option with SpO2, SpCO, and SpMet monitoring, Oridion microMediCO2 module replaces miniMediCO2 module, Expanded Data Logging capabilities, Wide-format printer option, Wireless Data Transfer.

This document describes a 510(k) premarket notification for the ZOLL X Series, a multi-functional medical device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific, new acceptance criteria for the ZOLL X Series or detailing performance against them. Most performance claims are implicit in the statement of substantial equivalence to previously cleared devices.

However, the document mentions specific functional aspects and their intended performance:

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not provide specific details on the sample size used for the test set or the data provenance for the features mentioned (CPR monitoring, AED rhythm analysis, 12-lead ECG interpretation).

The filing relies heavily on the "substantial equivalence" argument, meaning that the performance of the integrated components (like the Inovise Audicor 12-Lead ECG Interpretive Algorithm) has already been established and reviewed in their original 510(k) clearances (e.g., K032145 for Inovise Audicor). The current filing does not present new clinical study data for these components themselves.

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 510(k) summary. For components like the 12-lead ECG interpretive algorithm, such details would have been part of its original 510(k) submission (K032145 for Inovise Audicor).

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A MRMC comparative effectiveness study is not explicitly mentioned or detailed in this 510(k) summary. The document emphasizes the device's functionality and substantial equivalence. For the 12-lead ECG analysis, it states, "The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data." This implies a human-in-the-loop approach where the device provides information for the caregiver, but it does not quantify improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

For components like the AED's rhythm analysis function and the 12-lead ECG interpretive algorithm, standalone performance would have been evaluated as part of their original clearance processes. The current submission for the ZOLL X Series integrates these cleared algorithms. The 510(k) summary refers to "Specifications for the ECG rhythm analysis function are provided in the Operator's Manual section 'ECG Analysis Algorithm Accuracy' on page A-33," suggesting that standalone algorithm performance data exists but is not included in this summary.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not explicitly stated in the 510(k) summary. For the 12-lead ECG interpretive algorithm, it is highly likely that expert consensus (e.g., multiple cardiologists' interpretations) would have been used as ground truth in its original validation studies. For AED algorithms, ground truth for rhythm detection typically comes from expert review of ECG waveforms.

8. The Sample Size for the Training Set

The 510(k) summary does not provide any information regarding the sample size for the training set for any of the algorithms or features. This information would typically be part of the original development and validation of the individual algorithms (e.g., Inovise Audicor).

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the 510(k) summary. Similar to the test set ground truth, the methodology for establishing ground truth for training data would have been detailed in the original submissions for the individual algorithms.

Summary of the Study Discussed in the Document:

The provided document is a 510(k) summary (K112432) for the ZOLL X Series. It is not a detailed clinical study report but rather a regulatory filing designed to demonstrate substantial equivalence to previously cleared predicate devices.

The "study" presented here is a collection of performance and safety testing aimed at showing that the newly configured ZOLL X Series, incorporating additional features and modules, functions as intended and is as safe and effective as its predicates.

According to the document:

• Type of Study: The document describes "Extensive performance testing" and "Safety testing" to ensure the device performs as well as predicate devices and meets its specifications. It is a design verification and validation effort rather than a comparative clinical effectiveness trial.
• Purpose: To demonstrate that the ZOLL X Series' new features (e.g., AED mode, CPR monitoring, See-Thru CPR, Inovise Audicor 12-Lead ECG Interpretive Algorithm, Masimo Rainbow MX3, Oridion microMediCO2) are substantially equivalent to previously cleared devices or modules.
• Key Finding: The conclusion states, "The information provided in this 510(k) demonstrates that the ZOLL X Series' features and functions are substantially equivalent to those of the indicated commercially distributed devices with regard to performance, safety and effectiveness."

In essence, this 510(k) summary indicates that the ZOLL X Series meets its acceptance criteria by demonstrating that its integrated components and overall system performance are equivalent to those of devices already cleared by the FDA, relying heavily on the pre-existing validation of those predicate devices and modules.

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