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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 X Series in 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.

Semiautomatic Operation (AED): X Series products are 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 X Series 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.

ECG Monitoring: The X Series 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.

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.

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 X Series 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. Measurements are made using an inflatable cuff on the patient's arm or leg.

Temperature Monitoring: The X Series 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.

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 hospitals, hospital-type facilities, or in mobile environments.

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

Invasive Pressure Monitoring: The X Series 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.

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.

Web Console: X Series Web Console functionality allows medical personnel to view physiological data available on a connected X Series device. Physiological data may include ECG, noninvasive blood pressure, SpO2/SpCO/SpMet, end-tidal carbon dioxide, respiration rate, invasive blood pressure, temperature, and Heart Rate. For each patient connected to an X Series, the X Series collects patient data, consolidates the data on an embedded web page that can be requested, through an Ethernet connection, by a web browser on a PC for display.

The X Series (reviewed and cleared with K112432 on 03/21/2012) is a lightweight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitors (including ECC, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and impedance respiration monitoring). With the current application we are proposing to revise the X Series software to support Web Console functionality which will allow remote personnel to view the content of one or multiple (up to forty) X Series device screens. Users of the new Web Console features can only view the data on monitors remotely, and cannot operate the X Series device, silence device alarms, or initiate any patient treatment remotely - this can only be done directly on the device, at the patient's bedside.

The provided text is a 510(k) summary for the ZOLL X Series medical device, focusing on an update that adds "Web Console functionality." It does not contain information about acceptance criteria, device performance, or a study specifically proving the device meets acceptance criteria for its primary functions (defibrillation, monitoring, pacing, etc.). Instead, the document assesses the substantial equivalence of the new Web Console functionality to a predicate device.

However, I can extract information related to the demonstration of substantial equivalence for the new Web Console functionality.

Here's a breakdown based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific acceptance criteria or quantitative performance metrics for the Web Console functionality. It states that "Safety, efficacy and substantial equivalence was shown through software verification and system level validation." The basis for substantial equivalence is that the new functionality cannot control the connected devices, silence alarms, or initiate patient treatment remotely, which aligns it with the functions of the predicate device (ZOLL RescueNet Link K111296).

Study Information for Web Console Functionality:

The document describes the assessment for the new Web Console functionality rather than the entire X Series device's core functions.

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

• Test Set Sample Size: Not specified. The document refers to "software verification and system level validation" and "performance testing" but does not provide details on the number of cases or data points used in these tests for the Web Console functionality.
• Data Provenance: Not specified. The tests would likely involve simulated or real X Series device data, but the origin (e.g., country, retrospective/prospective) is not mentioned.

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

• Not applicable/Not specified. The assessment for the Web Console functionality does not appear to involve establishing ground truth through expert review in the way a diagnostic AI might. The focus is on verifying its ability to display data and its inability to control the device remotely.

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

• Not applicable/Not specified. This type of adjudication method is typically used for clinical trials involving human interpretation of medical images or data, which is not the nature of the assessment described for the Web Console functionality.

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. An MRMC comparative effectiveness study was not done. The Web Console functionality is for viewing data, not for interpretation or diagnosis by AI affecting human reader performance.

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

• Yes, in a sense. The "software verification and system level validation" and "performance testing" are evaluations of the algorithm/software functionality itself. However, it's not a standalone diagnostic algorithm that makes decisions. It's a viewer. The crucial "standalone" aspect here is that the Web Console cannot operate the X Series remotely, confirming its role as a viewer only.

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

• Not explicitly defined in terms of clinical ground truth. For the Web Console, the "truth" would be whether it accurately displays the data transmitted from the X Series device and whether it correctly prevents remote control actions. This is verified through "software verification and system level validation" against functional requirements and specifications.

8. The sample size for the training set:

• Not applicable. The Web Console is a software update for viewing data, not a machine learning model that requires a training set.

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

• Not applicable, as there is no training set for this functionality.

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PocketCPR Intended Use: To assist users in the performance of effective CPR on a patient 8 years or older.

Effective cardiopulmonary resuscitation (CPR), when administered quickly after the on-set of cardiac arrest, is effective at saving lives and enabling complete neurological recovery, especially when followed by early defibrillation. The PocketCPR® was developed to provide users with real-time feedback during the administration of CPR, to assist CPR instructors during class exercises, and to provide CPR students with verbal instructions and feedback for at-home practice. When the PocketCPR is turned on, the default protocol being driven by the 2010 American Heart Association's (AHA) Guidelines, reminds the user to call for help. Once placed on the patient's chest and chest compressions have begun, PocketCPR generates a metronome at the recommended rate of chest compression, gives verbal and visual feedback on the quality of CPR being delivered and reminds the user to give two breaths after every 30 compressions. Measurement of actual chest wall movement is made by a state-of-the-art accelerometer micro-chip and microprocessor performing continuous analysis.

The provided text describes the PocketCPR® device, an aid for Cardiopulmonary Resuscitation (CPR), and its substantial equivalence to a predecessor device. However, it does not include specific acceptance criteria (e.g., target performance metrics like sensitivity, specificity, accuracy for CPR feedback) or a detailed study proving the device meets such criteria.

The bulk of the "Types of Testing" section lists various bench tests, simulated use on a manikin, usability studies, and biocompatibility, but it doesn't provide performance results against specific, quantifiable acceptance criteria.

Therefore, I cannot fully answer your request based on the provided text for certain points as the information is not present. I will indicate where information is missing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for CPR Feedback: Specific numerical acceptance criteria (e.g., what percentage accuracy is required for depth, rate, or release feedback) are not explicitly stated in the provided document. The document states the device "generates a metronome at the recommended rate of chest compression, gives verbal and visual feedback on the quality of CPR being delivered and reminds the user to give two breaths after every 30 compressions." This describes the functionality but not the performance targets or the measured performance against those targets.

Reported Device Performance: Similarly, specific quantitative performance data (e.g., measured accuracy of depth detection, rate measurements, or percentage of correct feedback instances) is not reported. The document notes "Measurement of actual chest wall movement is made by a state-of-the-art accelerometer micro-chip and microprocessor performing continuous analysis," but actual performance results are absent.

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

• Test Set Description: The document mentions "Simulated Use on Computerized Manakin for Data Collection" and "Usability Studies performing CPR using PocketCPR."
• Sample Size for Test Set: The sample size for these tests is not specified.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the mention of "Computerized Manakin" and "Usability Studies," it's highly likely the data was collected prospectively in a controlled environment.

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

This information is not provided in the document. The type of ground truth used (manikin performance, expert observation) is not detailed, nor is the number or qualifications of any experts involved in assessing performance.

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

This information is not provided in the document.

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

• MRMC Study: An MRMC comparative effectiveness study, which typically compares human performance with and without AI, is not described in the document. The device is a direct feedback tool, not an "AI" in the typical sense of interpreting complex diagnostic images or data for a human reader. Its function is to directly guide the user.
• Effect Size: Therefore, effect size related to human reader improvement with AI assistance is not applicable or reported here.

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

• Standalone Performance: The document mentions "Measurement of actual chest wall movement is made by a state-of-the-art accelerometer micro-chip and microprocessor performing continuous analysis." While this implies an internal algorithm for measurement, no standalone performance evaluation of this algorithm's accuracy (e.g., against a gold standard for force or depth measurement) is explicitly detailed with specific metrics. The testing rather focuses on the device's output (feedback) in simulated use.

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

• The document implies that the ground truth for the "Simulated Use on Computerized Manakin for Data Collection" and "Usability Studies" likely involves:
  • Manikin-based measurements: Computerized manikins are designed to accurately measure CPR parameters (depth, rate, recoil). This would serve as a form of objective, engineered ground truth.
  • Compliance with AHA Guidelines: The ultimate "ground truth" for the device's feedback is its adherence to the 2010 American Heart Association (AHA) Guidelines for CPR.

8. The sample size for the training set

• The document describes the device as being "programmed to meet the 2010 AHA Guidelines." It does not mention a "training set" in the context of machine learning. The device's "programming" is based on the AHA guidelines rather than learned from a dataset.
• Therefore, a "training set sample size" in the conventional machine learning sense is not applicable or provided.

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

• As above, there is no mention of a "training set" for a machine learning model. The device's operational logic and feedback parameters are derived directly from the 2010 American Heart Association (AHA) Guidelines for CPR. These guidelines represent the accepted "ground truth" for effective CPR practices.

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The ZOLL R Series® External Defibrillator is intended for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including ECG Monitoring, Pulse Oximetry, Non-Invasive Blood Pressure measurement (proposed), End Tidal CO2 (proposed), CPR performance and data printing and recording for resting patients in critical care and in-hospital transport. The ZOLL R Series 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.

Defibrillator Function:
Manual Operation: Use of the R 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: 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. In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate. The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).
Semiautomatic Operation (AED): The R Series products are 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 R Series 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.

ECG Monitoring: The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.

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.

External Pacemaker (Pacer Version Only):
Pacemaker: 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.

SpO2 Monitoring: The R Series pulse oximeter, with the Masimo® SET® technology and the LNCS® series of oximeter sensors, is indicated for the continuous, monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for adult patients, and no motion conditions for pediatric and neonatal patients in a hospital or prehospital environment.

NIBP Monitoring: The ZOLL R Series NIBP option is indicated for the non-invasive measurement of arterial blood pressure for resting patients in critical care and in-hospital transport.

EtCO2 Monitoring: The ZOLL R Series EtCO2 option with Respironics Novametrix technology is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, in-hospital transport, or anesthesia.

The ZOLL R Series® External Defibrillator is intended for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including ECG Monitoring, Pulse Oximetry, Non-Invasive Blood Pressure measurement (proposed), End Tidal CO2 (proposed), CPR performance and data printing and recording for resting patients in critical care and in-hospital transport. The ZOLL R Series 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. The design facilitates table top use while still providing a light weight and easy to carry device for transport.

The provided text describes ZOLL R Series® NIBP and EtCO2 Options, a multi-parameter monitor, but does NOT contain specific acceptance criteria, detailed performance study results, or information about AI/ML algorithms.

The document states:

"Extensive performance testing ensures that the ZOLL R Series with NIBP and EtCO2 Options performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards."

This is a general statement about testing without providing quantifiable acceptance criteria or detailed results. The submission focuses on demonstrating substantial equivalence to a predicate device (ZOLL E Series NIBP and EtCO2 Options).

Therefore, I cannot fulfill the detailed request for acceptance criteria, device performance, sample sizes, expert qualifications, or details specific to AI/ML comparative effectiveness or standalone studies.

Based on the provided text, I can only provide the following limited information:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics. It generally states that "Extensive performance testing ensures that the ZOLL R Series with NIBP and EtCO2 Options performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications."

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

This information is not provided in the document.

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)

This information is not provided in the document, as the device is a medical monitor, not an AI/ML diagnostic tool requiring expert ground truth for its performance validation in the typical sense.

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

This information is not provided in the document.

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

The document does not mention an AI/ML component or an MRMC study. This device is a monitor, not a diagnostic AI/ML tool intended to assist human readers.

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

This document does not describe an AI/ML algorithm or a standalone performance study for such an algorithm.

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

The document focuses on the measurement capabilities (NIBP, EtCO2) and functionality of a monitor, not on an algorithm requiring ground truth in the context of diagnostic interpretation. Device performance would typically be validated against reference standards for physiological measurements. No details on this are provided beyond the general statement of "extensive performance testing."

8. The sample size for the training set

This information is not provided as the document does not describe an AI/ML algorithm that would undergo a training phase.

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

This information is not applicable as the document does not describe an AI/ML algorithm that would require a training set with established ground truth.

Summary of Device and Testing Approach from the Document:

The ZOLL R Series® NIBP and EtCO2 Options is a multi-parameter monitor. The regulatory submission emphasizes substantial equivalence to a predicate device (ZOLL E Series NIBP and EtCO2 Options) rather than comprehensive de novo performance studies with detailed statistical results. The testing described is "extensive performance testing" and "safety testing" to ensure it meets functional requirements, performance specifications, and complies with industry and safety standards, similar to the predicate device.

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The ZOLL E Series External Defibrillator is indicated for the defibrillation, Noninvasive 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 and data printing and recording for resting patients in critical care and transport. The ZOLL E Series 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.

Defibrillation: Use of the E Series products in the manual mode for defibrillation is indicated for converting/terminating ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. 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.

External Pacemaker (Pacer Version Only): This product may be used for temporary external, demand or non-demand pacing, as an alternative to endocardial stimulation. External cardiac pacing is indicated for use on conscious or unconscious patients in asystole, profound bradycardia or any other conditions determined by a clinician to require external pacing.

ECG Monitoring: The device is indicated for monitoring a patient's electrocardiogram (ECG), via the 3 or 5 lead patient cable, MFE Pads, or through the paddles, for the purposes of identifying and diagnosing cardiac rhythms and dysrhythmias and calculating heart rate.

SpO2 Option (if equipped): The SpO2 Option with Masimo Set Technology is indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate for adult, pediatric and neonatal patients, during both no motion and patient motion conditions, and for patients who are well or poorly perfusing in the hospital or pre-hospital environments.

EtCO2 Option (if equipped): The EtCO2 Option with Respironics Novametrix Technology and Capnostat® is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in adult, pediatric and neonatal patient's requiring ventilatory support, transport and anesthesia.

12SL Analysis Option (if equipped): The 12SL™ Analysis Option using the GE/Marquette 12SL™ Algorithm is useful in the diagnosis of patients with acute myocardial infarction (AMI) and is useful in the diagnosis of patients with other transient cardiac arrhythmias. The interpretation and 12-Lead ECG Analysis is indicated for the recording and analysis of ECG signals acquired from adult and pediatric patients in the supine, resting position.

NIBP Option (if equipped): The NIBP Option with SunTech Medical Systems, Inc. Technology is indicated for the noninvasive measurement of arterial blood pressure for resting patients in critical care and transport. The NIBP Option on M Series units is designed to measure blood pressure for adult, pediatric, and neonatal patients.

The ZOLL E Series External Defibrillator is indicated for the defibrillation, Noninvasive 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 and data printing and recording for resting patients in critical care and transport. The ZOLL E Series 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.

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. The E Series uses either standard paddles or disposable, pre-gelled, MFE Pads for defibrillation.

The provided document is a 510(k) summary for the ZOLL E Series defibrillator and does not contain information regarding objective performance acceptance criteria or a study designed to prove the device meets such criteria for AI/ML-driven features.

The document discusses the substantial equivalence of the ZOLL E Series to predicate devices based on:

• Technological Characteristics: The design characteristics are the same as indicated predicate devices, and the technology is very similar to the ZOLL M Series. ECG analysis algorithms are identical to those in the ZOLL AED Plus defibrillator.
• Performance Testing: "Extensive performance testing ensures that the ZOLL E Series Defibrillator meets all of its functional requirements and performance specifications."
• Safety Testing: "Safety testing assures the device complies with applicable sections of recognized industry and safety standards."

However, it does not detail specific acceptance criteria for the mentioned "ECG Analysis Algorithms" or "12SL Analysis Option," nor does it describe a study with a test set, ground truth, or statistical endpoints typically associated with AI/ML device performance evaluation as per your request. The document describes a traditional medical device clearance process focused on equivalence to existing devices, functional requirements, and safety standards.

Therefore, I cannot provide the requested information in the format specified.

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The ZOLL Autoclavable Internal Handles are to be used with interchangeable electrodes and a manually operated ZOLL Defibrillator to defibrillation therapy directly to the heart during surgical procedures.

When used with a ZOLL Defibrillator equipped with an advisory or ECG analysis feature. the ZOLL Autoclavable Internal Handles allows the defibrillator to operate only as a manual device.

The ZOLL Autoclavable Internal Handles are intended for use by or under the direction of a physician.

The ZOLL Autoclavable Internal Handles with Integrated Electrodes are to be used with a manually operated ZOLL Defibrillator to provide defibrillation therapy directly to the heart during surgical procedures.

When used with a ZOLL Defibrillator equipped with an advisory or ECG analysis feature, the ZOLL Autoclavable Internal Handles with Integrated Electrodes allows the defibrillator to operate only as a manual device.

The ZOLL Autoclavable Internal Handles with Integrated Electrodes are intended for use by or under the direction of a physician.

The ZOLL Autoclavable External Paddles are to be used with manually operated ZOLL M Series Defibrillator products to perform closed chest defibrillation of a patient when sterlization of the paddles is required either before or after the defibrillation event.

The ZOLL Autoclavable External Paddles are intended for use by trained personnel and are for use on Adult patients only.

The ZOLL Autoclavable External Paddles are intended for use by or under the direction of a physician.

Not Found

This document describes a 510(k) premarket notification for the "Zoll Autoclavable Internal Handles, Zoll Autoclavable Internal Handles with Integrated Electrodes and Zoll Autoclavable External Paddles." This is a regulatory clearance for a medical device and not a study proving device performance against acceptance criteria.

The 510(k) process primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not typically part of a 510(k) submission document in the way it would be for a clinical trial reporting.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This means the device was found to be as safe and effective as a device already on the market, not that a new study with explicit acceptance criteria was performed.

Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not a detailed performance study with acceptance criteria.

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The ZOLL M Series EtCO2 LoFlo™ Option is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in intubated and non-intubated adult, pediatric and infant patients requiring ventilator support, procedural sedation, transport, anesthesia and other clinical vonditions where EtCO, monitoring is deemed appropriate by the attending care giver. The M Series EtCO2 LoFlo™ Option uses nasal and nasal/oral sampling cannulas and sidestream on-airway adapter kits.

The ZOLL M Series EtCO2 Option with Respironics Novametrix technology and Capnostat® sensor is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, transport, and anesthesia. The M Series EtCO2 Option is designed to monitor adult, pediatric, and neonatal patients.

The ZOLL M Series EtCO2 Option with LoFlo™ Sidestream CO2 is a sidestream sampling system using a 50ml/minute low sampling rate to measure the EtCO2 of non-intubated and intubated infant, pediatric and adult patients using specially designed sampling cannulas and on-airway adapter kits.

The LoFlo™ Sidestream CO2 module includes Respironics Novametrix CAPNOII infrared absorption technology. The module is contained in a small plastic enclosure with a short cable that connects to the same M Series connector used by the existing EtCO2 Capnostat 3 sensor. The module uses the same hardware communications interface to the M Series as the existing Capnostat 3 sensor and a slightly expanded software communications protocol.

The provided text describes a 510(k) summary for the ZOLL M Series EtCO2 LoFlo™ Option. It states that "Extensive performance testing ensures that the ZOLL M Series EtCO2 LoFlo™ Option meets all of its functional requirements and performance specifications" and concludes that "Performance and safety testing of the ZOLL M Series EtCO2 LoFlo™ Option demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness."

However, the document does not provide specific details on the acceptance criteria (e.g., threshold values for accuracy, precision, etc.) or the detailed results of the performance testing. It also lacks information on the methodology of such a study, including sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

Therefore,Based on the provided document (K042417), I cannot provide a detailed description of the acceptance criteria and the study that proves the device meets them because the document does not contain this specific information.

The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent performance study with specific acceptance criteria and results. The document states:

• "Extensive performance testing ensures that the ZOLL M Series EtCO2 LoFlo™ Option meets all of its functional requirements and performance specifications."
• "Performance and safety testing of the ZOLL M Series EtCO2 LoFlo™ Option demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness."

This indicates that internal testing was conducted to ensure the device met its own specifications and to support the substantial equivalence claim. However, the details of these tests, including specific acceptance criteria, reported performance values, sample sizes, and ground truth methodologies, are not included in this 510(k) summary.

Without this specific information in the provided text, I cannot complete the requested table or answer the detailed questions about the study design.

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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).

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.

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The ZOLL Autoclavable Internal Handles with Integrated Electrodes are to be used with a manually operated ZOLL Defibrillator to defibrillate the heart during surgical procedures.

When used with a ZOLL defibrillator equipped with an advisory or ECG analysis feature, the ZOLL Autoclavable Internal Handles with Integrated Electrodes allow the defibrillator to operate only as a manual device.

The ZOLL Autoclavable Internal Handles with Integrated Electrodes are intended for use by or under the direction of a physician.

ZOLL Autoclavable Internal Handles with Integrated Electrodes

This document is a 510(k) premarket notification decision letter from the FDA for the ZOLL Autoclavable Internal Handles with Integrated Electrodes. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document is a regulatory approval letter, not a technical study report.

Therefore, I cannot provide the requested information based on the input text.

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The ZOLL M Series Bi-Phasic Defibrillator is to be used only by qualified medical personnel for converting ventricular fibrillation (VF), a cardiac rhythm incompatible with life, and/or Ventricular Tachycardias (VT) to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.

In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Atrial Fibrillation (AF) at lower energy and currents than monophasic defibrillators. A qualified physician must decide when synchronized cardioversion is appropriate.

In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Ventricular Tachycardias (VT). A qualified physician must decide when synchronized cardioversion is appropriate.

The AED or advisory function should only be used to confirm the presence of ventricular fibrillation in patients meeting the following clinical criteria:

• the patient should be unconscious and unresponsive
• the patient should be apneic (not breathing)
• the patient should be pulseless .

Not Found

The provided document is an FDA 510(k) clearance letter for the ZOLL M Series Bi-Phasic Option, a low energy DC defibrillator.

This document does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a 510(k) summary. The letter primarily confirms that the device has been found substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements.

However, the third page (Image /page/2/Picture/1) of the document mentions:

"The Rectilinear Biphasic Waveform (RBW) has been successfully tested in multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials, proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices."

This sentence indicates that clinical trials were performed to demonstrate the effectiveness of the device's waveform. However, the letter does not provide specific details regarding:

• Acceptance Criteria Table: No table of acceptance criteria or reported device performance is present.
• Sample Size or Data Provenance for Test Set: The document states "multi-center, prospective, randomized... clinical trials" but does not provide specific sample sizes or countries of origin.
• Number/Qualifications of Experts for Ground Truth: Not mentioned.
• Adjudication Method: Not mentioned.
• MRMC Comparative Effectiveness Study: The letter states the device was "proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices." This implies a comparison, but it doesn't specify if it was an MRMC study with human readers or solely focused on device performance. No effect size for human reader improvement is provided.
• Standalone Performance: The "proven to defibrillate and cardiovert" statement implies standalone performance was assessed.
• Type of Ground Truth: Implied to be clinical outcomes (defibrillation/cardioversion success), but not explicitly detailed.
• Training Set Sample Size: Not mentioned, as this is a clinical trial, not an AI model training.
• Ground Truth for Training Set: Not applicable in the context of device performance trials as typically described in this letter.

In summary, while the document states that clinical trials were performed and were successful in demonstrating the device's capability, it does not provide the level of detail requested regarding acceptance criteria, study design parameters, or ground truth establishment that would be found in a comprehensive study report for an AI/CADe device.

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The ZOLL M Series NIBP Option is indicated for the noninvasive measurement of arterial blood pressure for resting patients in critical care and transport. The NIBP Option on M Series units is designed to measure blood pressure for adult, pediatric, and neonatal patients.

The ZOLL M Series NIBP Option non-invasively measures arterial blood pressure and pulse rate in resting adult, neonate and pediactric patients. By incorporating the SunTech Medical Instruments Advantage OEM BP™ Model 2 Module into the M Series Defibrillator/Monitor/Pacemaker devices, the option facilitates the ability to monitor and assess the physiological characteristics of the indicated patient populations.

The ZOLL M Series products (K972241) combine a defibrillator, ECG display, Noninvasive Transcutaneous Pacing, Pulse Oximetry (K982992), End Tidal CO2 (K993036), 3-, 5- and 12-Lead ECG Monitoring (K991556), Non-Invasive Blood Pressure measurement (K002029) and Invasive Blood Pressure and Temperature (K011865), data printing and recording in a single instrument.

The provided text describes ZOLL Medical Corporation's 510(k) submission for the M Series NIBP Option (K032363), a non-invasive blood pressure measurement device. The submission asserts substantial equivalence to the predicate device, Protocol Systems, Inc. Propaq CS Vital Signs Monitor (K012451), based on performance information and compliance with various standards.

Here's the breakdown of the acceptance criteria and study information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance evaluation. It only states that the 510(k) includes "documentation related to the performance of the incorporated NIBP module and compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards." This implies that the performance was assessed against these standards, but the details of the study (e.g., number of subjects, type of data) are not included.

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

The provided text does not mention experts used to establish ground truth or their qualifications. The evaluation appears to be based on compliance with established engineering and performance standards for NIBP devices, rather than a clinical ground truth established by experts.

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

The provided text does not describe any adjudication method. This type of detail is typically associated with studies involving human interpretation or subjective assessments, which are not explicitly detailed here for the NIBP device performance.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. This study type is usually relevant for AI-powered diagnostic tools where human interpretation is involved. The ZOLL M Series NIBP Option is a measurement device, and its performance evaluation is framed around compliance with technical standards.

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

The provided text suggests that the performance evaluation was primarily focused on the device's technical specifications and its compliance with relevant standards (ANSI/AAMI SP-10-1992, EN 1060 series, IEC 60601 series, AAMI DF2, AAMI DF39). This implies a standalone assessment of the device's accuracy and safety against pre-defined benchmarks, without explicit mention of human operators in the loop influencing the measurement performance reported for regulatory submission. The device is used by humans, but the performance testing described focuses on its intrinsic measurement capabilities.

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

The "ground truth" for the device's performance is implicit in the standards it aims to comply with. For blood pressure measurement devices, this typically refers to a reference method (e.g., direct arterial measurement or a highly accurate auscultatory method) against which the automated device's readings are compared. The text explicitly lists various ANSI/AAMI, CEN, and IEC standards for automated noninvasive blood pressure, defibrillator, and monitor systems. These standards define the expected accuracy and performance limits, which serve as the "ground truth" or reference for the device's validation.

8. The sample size for the training set

The provided text does not mention a training set or its size. This is typical for medical devices that are not "learning" algorithms in the modern sense (e.g., AI/ML). The NIBP module is an established technology, and its performance is validated against engineering and clinical standards rather than being "trained" on data.

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

Since no training set is mentioned, the method for establishing its ground truth is not applicable based on the provided text.

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