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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).
  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.
  The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.
  The Real CPR Help 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 in accordance with AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients.
  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.
  The R Series pulse oximeter, with the Masimo® SET® technology and the LNCS® series of oximeter sensors, is indicated for the continuous, noninvasive 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.
  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 NIBP option is indicated for the non-invasive measurement of arterial blood pressure for resting patients in critical care and in-hospital transport.

The ZOLL R Series® External Defibrillator is intended for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including Franboataneous Pulse Oximetry, Non-Invasive Blood Pressure measurement, End Tidal CO2 Monitening, Fulls and data printing and recording for resting patients in critical care and 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 proposed enhancements to the ZOLL R Series are intended to provide personnel trained in its use with modified CPR feedback. The display of the Real CPR Help technology has been modified to provide rescuers with feedback data for chest compression depth, rate, and release. The proposed changes are also intended to support a modified pediatric electrode with a CPR feedback sensor.

The ZOLL R Series external defibrillator with modifications to its CPR feedback feature and the addition of a CPR feedback sensor to pediatric electrodes.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not explicitly state numerical acceptance criteria for the modified CPR feedback feature or the pediatric electrode with the CPR feedback sensor. Instead, it refers to:

• AHA/ERC recommended rate of 100 compressions per minute.
• AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients for compression depth.

The document states that the "Real CPR Help 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 in accordance with AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients." This implies that the device's performance aligns with these recommendations by providing appropriate feedback to guide users to meet them.

Without explicit numerical acceptance criteria, a table cannot be fully constructed. However, if we infer the acceptance criteria from the intended function, it would be:

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

The document states that "Extensive performance testing ensures that the proposed ZOLL R Series 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."

No specific sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective) is provided for the CPR feedback modifications or the pediatric electrode. The testing seems to be internal performance and safety testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided. The document refers to compliance with "recognized industry and safety standards" and the device's ability to drive users toward "AHA/ERC recommendations," but it does not detail a process for establishing ground truth via experts for the performance of the CPR feedback mechanism itself during testing.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned. The testing described is general performance and safety testing, not a clinical study requiring adjudication of expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The document focuses on the device's functionality and its ability to guide users to follow established guidelines, not on a comparison of human reader performance with or without AI assistance. This device is not an AI-assisted diagnostic tool in the sense of image analysis.

6. Standalone (Algorithm Only) Performance Study:

The document implies a standalone performance for the CPR feedback algorithm in that it states the algorithm "provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate." This suggests the algorithm itself was tested to ensure its feedback mechanism is accurate and effective in guiding compressions to the specified rates and depths. However, no specific standalone study details (e.g., methodology, specific metrics, results in isolation from a human user) are provided.

7. Type of Ground Truth Used (for CPR feedback):

The implied ground truth for the CPR feedback mechanism is based on established medical guidelines and recommendations:

• AHA/ERC recommended chest compression rate (100 bpm).
• AHA/ERC recommended chest compression depth (≥ 2 inches / 5 cm for adults).

The device is designed to provide feedback to help rescuers achieve these established standards.

8. Sample Size for the Training Set:

This information is not applicable or provided. The CPR feedback feature appears to be based on an algorithm that monitors physical parameters (rate, depth, release) and provides feedback based on pre-defined thresholds derived from medical guidelines, rather than being trained on a large dataset like a machine learning model for diagnosis.

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

This information is not applicable or provided. As above, the device's functionality seems to stem from a rules-based system implementing established medical guidelines, not from a machine learning training process that requires a dedicated training set with established ground truth.

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The ZOLL R Series® External Defibrillator is intended for the defibrillation. Noninyasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including ECG Monitoring, Pulse Oximetry, Non-Invasive Blood Pressure measurement, End Tidal CO2, CPR performance and data printing and recording for resting patients in critical care and 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 ZOLL R Series® External Defibrillator is intended for the defibrillation. Noninyasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including ECG Monitoring, Pulse Oximetry, Non-Invasive Blood Pressure measurement, End Tidal CO2, CPR performance and data printing and recording for resting patients in critical care and 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 ZOLL R Series software, which currently supports the 2005 American Heart Association's (AHA) Guidelines for CPR, has been revised to optionally support the new revised 2010 AHA's Guidelines for CPR. The specific changes include:

• Adding, in the form of a configuration option, a minimum CPR target compression depth . of at least 2.0 inches in addition to the 2005 AHA guidelines depth as described in Chapter 6 of the R Series ALS Operator's guide included in Attachment 11-1 and Chapter 7 of of the R Series Plus/ R Series BLS Operator's Guide included in Attachment 11-2. Both depth configurations are necessary since the training to and implementation of the new guidelines occur over a number of years.
• . Adding an optional configuration option to display an informational message to remind the users to release their hands from the chest between compressions in order to allow the chest to recoil. When the R Series is configured to display this new message, the message FULLY RELEASE will be displayed every 45 seconds, for 5 seconds, as long as CPR compressions are detected.

The provided text describes a 510(k) Summary for the ZOLL R Series® with a 2010 AHA Guidelines Software Update. This document details the device's intended use, technological characteristics, and a general statement about performance testing, but it does not contain specific acceptance criteria, detailed study designs, or reported performance metrics for the updated software features related to the 2010 AHA guidelines. The document primarily focuses on establishing substantial equivalence to previously cleared devices.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Extensive performance testing ensures that the ZOLL R Series Defibrillator meets all of its functional requirements and performance specifications." And "Performance testing of the ZOLL R Series Defibrillator demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."

However, no specific acceptance criteria (e.g., minimum accuracy percentages, sensitivity/specificity thresholds) or the results of this "extensive performance testing" are provided for the software update. The original device (without the 2010 AHA update) would have had such criteria, but they are not detailed for the changes introduced by this specific submission. The new software specifically changes the CPR compression depth prompt from 1.5"-2.0" to "at least 2.0"" and adds a "FULLY RELEASE" message. No performance metrics are given for these specific new features.

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

Not specified in the provided text for the software update.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not specified in the provided text for the software update.

4. Adjudication Method for the Test Set:

Not specified in the provided text for the software update.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not mentioned in the provided text. The submission is for a software update that primarily changes CPR feedback prompts, not for an AI-assisted diagnostic tool that would typically undergo MRMC studies.

6. Standalone (Algorithm Only) Performance Study:

Not directly addressed as a "standalone" study in the context of an AI algorithm. The software update is integrated into a medical device. The document implies that the device's overall performance was tested, but not specifically the algorithm driving the new CPR feedback in isolation with detailed metrics.

7. Type of Ground Truth Used:

Not specified for the software update. For the original "ECG Rhythm Analysis Algorithm Accuracy" mentioned on page A-29 (not included in the provided text but referenced), the ground truth for rhythm analysis would typically be expert cardiologist review, but this is not confirmed for the new software.

8. Sample Size for the Training Set:

Not applicable. The software update primarily adjusts existing CPR feedback logic based on updated AHA guidelines. There is no mention of a machine learning model being trained with data.

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

Not applicable. As above, there's no indication of a training set for a machine learning model. The basis for the software changes is the 2010 American Heart Association Guidelines for CPR.

Ask a specific question about this device

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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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).

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.

The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.

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.

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.

The R Series pulse oximeter, with the Masimo® SET® technology and the LNOP® series of oximeter sensors, is indicated for the continuous, noninvasive 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.

The ZOLL R Series® External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, CPR performance and data printing and recording for resting patients in critical care and 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. Some R Series products include an optional transcutaneous pacemaker consisting of a pulse generator and ECG-sensing circuitry. The proposed enhancement to the R Series will provide the user with a simplified user interface. The ZOLL R Series BLS Defibrillator combines an AED operating mode with manual override capability.

The provided text states that "Extensive performance testing ensures that the R Series Defibrillator with BLS Option meets all of its functional requirements and performance specifications" and that "Functional testing of the device's features and functions was conducted to ensure that the modifications to the software and hardware did not degrade or impact other product features, functions or performance specifications."

However, specific acceptance criteria or detailed results of those performance tests are not explicitly described in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (ZOLL R Series K060559) and lists its intended uses and specifications for various functions (defibrillation, pacing, SpO2 monitoring, CPR monitoring) but it does not contain a table of acceptance criteria and reported performance, nor does it detail a study that explicitly "proves the device meets the acceptance criteria" in terms of specific performance metrics.

Based on the provided text, here's what can be inferred and what information is missing:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: This is not present in the document.
• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No details about specific test sets, sample sizes, or data provenance are given.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information on adjudication is given.
• If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: The document does not mention an MRMC study.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the device has an "ECG Rhythm Analysis Algorithm Accuracy" section mentioned (on page 29, not included here), the details of any standalone performance study for this algorithm are not provided.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This is not specified for any testing done.
• The sample size for the training set: No information on a training set is provided.
• How the ground truth for the training set was established: No information on a training set is provided.

The document only states the following regarding performance testing:

Acceptance Criteria and Reported Device Performance

The document broadly states that the device "meets all of its functional requirements and performance specifications."
The basis for acceptance is stated as "Extensive performance testing ensures that the R Series Defibrillator with BLS Option meets all of its functional requirements and performance specifications. Functional testing of the device's features and functions was conducted to ensure that the modifications to the software and hardware did not degrade or impact other product features, functions or performance specifications."

The Study that Proves the Device Meets Acceptance Criteria:

The document describes "Performance Testing" as:
"Extensive performance testing ensures that the R Series Defibrillator with BLS Option meets all of its functional requirements and performance specifications. Functional testing of the device's features and functions was conducted to ensure that the modifications to the software and hardware did not degrade or impact other product features, functions or performance specifications."

The conclusion drawn from this testing is:
"Testing of the R Series Defibrillator with BLS Option demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety and effectiveness."

This suggests that the "study" was primarily functional testing to ensure that the new device, as a modification of a previously cleared predicate (K060559), did not degrade existing performance and maintained substantial equivalence. Specific details of this "extensive performance testing" are not provided in this 510(k) summary. It references "Specifications for the ECG rhythm analysis function are provided in this section, 'ECG Rhythm Analysis Algorithm Accuracy' on page 29," which implies more specific data exists but is not included in this extract.

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The ZOLL R Series® External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetrey, CPR performance and data printing and recording for resting patients in critical care and 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 ZOLL R Series with WiFi Option is intended to be used by qualified medical professionals for the wireless transmission of data files, such as Summary Reports, Full Disclosure Waveforms and Device Logs between the R Series to a network server or handheld device.

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).

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 involing 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.

The ZOLL R Series® External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetrey, CPR performance and data printing and recording for resting patients in critical care and 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 ZOLL R Series with WiFi Option is intended to be used by qualified medical professionals for the wireless transmission of data files, such as Summary Reports, Full Disclosure Waveforms and Device Logs between the R Series to a network server or handheld device.

The provided text is for a 510(k) summary for the ZOLL R Series® WiFi Option. Upon review of the submission, there is no specific performance study data or acceptance criteria for the WiFi option itself.

The submission states:
"Extensive performance testing ensures that the ZOLL R Series with WiFi Option performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures the device complies with applicable sections of recognized industry and safety standards."

It then concludes that "Performance and safety testing of the ZOLL R Series with WiFi Option demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."

This indicates that the WiFi option was evaluated against existing standards and the performance of the predicate device (ZOLL R Series K060559) to show substantial equivalence. This type of submission relies on the existing clearance of the base device and demonstrates that the added WiFi functionality does not negatively impact safety or effectiveness, and performs its specific function (wireless data transmission) as expected.

Therefore, I cannot provide the requested table or information regarding specific acceptance criteria, sample sizes, ground truth establishment, or clinical study details as they are not present in the provided 510(k) summary for the WiFi option. The submission focuses on substantial equivalence to a predicate device rather than a de novo performance study for the WiFi functionality itself.

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Defibrillation: Use of the R Series products in the manual and semiautomatic modes 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 heartbeats. In manual mode, the unit can also be used for synchronized cardioversion to atrial fibrillation (AF) or ventricular tachycardia (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 in patients meeting the three conditions indicating lack of circulation (previously listed).

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 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 detection of salient cardiac rhythms and dysrhythmias and calculating heart rate.

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 CPR monitoring function is not intended for use on patients under 8 years of age.

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.

The ZOLL R Series External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, CPR performance and data printing and recording for resting patients in critical care and 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 device is capable of providing Basic Life-Saving (BLS) personnel the option of analyzing an adult or pediatric 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 re-assess the patient in the event a no shock advised determination is returned. Therapy is provided by using defibrillation electrode products specifically designed for use with the R Series. When used in conjunction with ZOLL Ready padz One-step CPR or Ready padz One-step Complete Electrodes, the R SERIES provides CPR compression performance feedback using displayed symbols, text messages and voice prompts.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the ZOLL R Series Defibrillator:

The provided document is a 510(k) summary for the ZOLL R Series Defibrillator, which focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel device with extensive new performance studies. Therefore, much of the requested information regarding detailed performance studies for new acceptance criteria is not explicitly stated in this type of submission. The document relies heavily on the fact that existing, cleared algorithms and technologies are being re-used.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the way a new device's performance study might. Instead, it states that the device reuses existing algorithms and technologies from predicate devices (ZOLL E Series and ZOLL AED Pro Defibrillator).

The primary acceptance criteria are implicitly met by demonstrating that the ECG Analysis Algorithms for shock/no-shock advisory and CPR Aid feature are "identical" or "similar" to those in the predicate devices which have already been cleared by the FDA.

Table 1: Implicit Acceptance Criteria and Reported Device Performance

Study Details

The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting a full, detailed clinical study report for a novel algorithm. For this reason, many of the requested details about specific performance studies (like sample sizes, expert qualifications, etc.) are not explicitly stated for the ZOLL R Series itself, but rather inferred from the predicate devices.

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

   • Not explicitly stated for the ZOLL R Series device. The document states that the ECG analysis algorithms are "identical" to the predicate ZOLL AED Pro. The CPR Aid feature is "similar." The performance of these predicate devices would have been evaluated with test sets, but those details are not provided in this summary for the R Series.

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

   • Not explicitly stated for the ZOLL R Series device. This information would typically be available in the detailed reports for the original predicate devices' algorithm validation, which are not included here.

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

   • Not explicitly stated for the ZOLL R Series device. Again, this detail would pertain to the validation of the algorithms in the predicate devices.

4. 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/Not stated for this submission. The device includes an "Advisory function" where the algorithm determines shockable/non-shockable rhythms and prompts the user. This is a form of AI assistance, but the submission doesn't describe a comparative effectiveness study in an MRMC format comparing human performance with and without this specific device's assistance. The focus is on the algorithm's performance equivalence to the predicate.

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

   • Implicitly yes, for the algorithm itself. The statement "The Advisory Algorithm will determine if the acquired heart rhythm is shockable or non-shockable" indicates a standalone assessment of the algorithm's performance, which is then presented to a human. However, the specific details of that standalone study (like sensitivity/specificity metrics) are not provided, only the assertion that the algorithm is "identical" to a previously cleared one.

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

   • Not explicitly stated for the ZOLL R Series device. For ECG rhythm analysis, ground truth is typically established by expert cardiologists reviewing the ECG waveforms. This would have been done for the predicate device.

7. The sample size for the training set:

   • Not explicitly stated for the ZOLL R Series device. As the algorithms are "identical" or "similar" to predicate devices, the training was done for those prior iterations, and the specifics are not in this document.

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

   • Not explicitly stated for the ZOLL R Series device. Similar to test set ground truth, for ECG algorithms, this would involve expert cardiologist review and labeling of ECG data.

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