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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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Intended Use: The HeartStart XL + is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician.

When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED.

When operating in Monitor, Manual Defib or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.

Indications for Use: The HeartStart XL+ is a defibrillator monitor. The device is for use by qualified medical personnel trained in the operation of the device and certified by training n basic life support, advanced life support or defibrillation. It must be used by or on the order of a physician.

AED Therapy: AED Mode is used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.

Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive.

Synchronous defibrillation (cardioversion) is indicated for termination of atrial fibrillation.

Non-Invasive External Pacing: The pacing option is indicated for treating patients with symptomatic bradycardia.

Pulse Oximetry: The SpO2 option is indicated for use when it is beneficial to assess the patient's oxygen saturation level.

Non-invasive Blood Pressure Monitoring: The NBP option is indicated for non-invasive measurement of a patient's arterial blood pressure.

ECG Monitoring: The ECG monitoring option is indicated to be used for monitoring, alarming, and recording of the patient's heart rate and morphology.

The HeartStart XL+ is a lightweight, portable defibrillator/monitor. It provides four clinical modes of operation: Monitor, Manual Defibrillator, AED and Pacer (optional).

In Monitor Mode, depending on the ECG inputs being used (pads, paddles, ECG cable), you can monitor up to 3 different ECG waveforms at one time. Using a 3-lead ECG cable you can view Lead I, II or III. With a 5-Lead ECG cable, you can view two leads from Leads I, III, avR, avF or V. Optional monitoring of SpO2 or NBP is available using existing and previously cleared technology as references in the predicate device comparison of the summary. Measurements are presented on the display and alarms are available to alert you to a change in the patient's condition. You can also display the Vital Signs Trending Report to view all key parameters and their measurements at a glance.

Manual Defibrillation Mode provides simple 1-2-3 defibrillation. You analyze the patient's ECG and, if appropriate: 1) select an energy setting; 2) charge; and 3) deliver the shock. Defibrillation is performed using paddles (internal or external) or multifunction electrode pads. You can also perform synchronized cardioversion in Manual Defibrillation Mode. The HeartStart XL+ incorporates Philips' low energy SMART Biphasic waveform for defibrillation which has been in use for over a decade.

In AED Mode, the HeartStart XL+ analyzes the patient's ECG and determines whether a shock is advised. Voice prompts guide you through the 2-step defibrillation process, with easy-to-follow instruction and patient information. Voice prompts are reinforced by messages on the display.

Optional Pacer Mode offers non-invasive transcutaneous pacing therapy. Pace pulses are delivered through multifunction electrode pads.

The provided text describes the Philips HeartStart XL+ Defibrillator Monitor, a medical device. The submission primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with explicit acceptance criteria for a new AI algorithm.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies, as they relate to a new AI algorithm or a distinct performance study, is not present in the provided document. The device is a defibrillator/monitor, and its "performance" is primarily assessed through compliance with recognized consensus standards and comparison to existing predicate devices.

However, I can extract information related to the device's technical specifications and the general approach to validating its equivalence.

Here's a breakdown of the available information in relation to your request:

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

This information is not explicitly stated as quantitative acceptance criteria for a new algorithm's performance in the document. Instead, the document focuses on compliance with established medical device standards and demonstrating equivalence to predicate devices. The "performance data" section states:

• "Testing for performance was done according to applicable FDA recognized consensus standards for electrical defibrillation, ECG monitoring, SPO2 monitoring, and NBP monitoring."
• "Additional standards testing beyond the list of FDA recognized standards was also performed."
• "Small feature changes have been made to align the design with the 2010 AHA Resuscitation Guidelines. The previous product had only been evaluated against the 2005 AHA guidelines."

The document implies that the device "performs" by successfully meeting these standards and aligning with clinical guidelines, but it doesn't provide a table of numerical acceptance criteria or specific performance metrics (e.g., sensitivity, specificity for an AI component) in the way one would expect for a novel algorithmic claim.

2. Sample size 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. The testing mentioned refers to conformance with applicable standards, which typically involves laboratory testing and potentially some clinical evaluation, but no details on specific sample sizes for a "test set" are given.

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. Given the nature of the device (defibrillator/monitor) and the focus on standards compliance and predicate device equivalence, the concept of "ground truth established by experts" in the context of an algorithm's diagnostic performance (like in AI studies) doesn't directly apply here. Clinical validation would involve qualified medical personnel, but this is not detailed.

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

An MRMC study is not mentioned in the document. This is a medical device approval for a physical defibrillator/monitor, not an AI-assisted diagnostic tool for human readers.

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

While the device includes internal algorithms (e.g., the HeartStream Patient Analysis System (PAS) Algorithm for AED mode), the document does not describe a "standalone" algorithmic performance study in the context of evaluating a new AI component. The algorithms integrated are existing and previously reviewed technologies, with the focus being on their integration into the new device and compliance with standards.

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

This information is not explicitly stated in the document in the context of a new algorithm's performance. For a device like this, "ground truth" would implicitly come from established physiological measurements, validated clinical conditions (e.g., actual cardiac arrest for AED function), and adherence to recognized medical guidelines (AHA Resuscitation Guidelines).

8. The sample size for the training set

This information is not provided. The document does not describe the development or training of a new algorithm that would require a dedicated training set. It leverages existing, previously cleared algorithms like the HeartStream Patient Analysis System (PAS) Algorithm.

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

This information is not provided. As above, the document focuses on integration of existing, cleared technologies rather than the development of a novel algorithm from scratch.

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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.

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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 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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The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.

Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation.

Non-invasive External Pacing Therapy: The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

Pulse Oximetry: The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.

Non-invasive Blood Pressure Monitoring: The NBP option is intended for non-invasive measurement of a patient's arterial blood pressure.

End-tidal CO2: The EtCO2 option is intended for non-invasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.

12-Lead ECG: The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.

Q-CPR: The Q-CPR™ option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time). The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less that 25 kg). The Q-CPR option is not for use when CPR is contraindicated.

Invasive Pressure: The Invasive Pressure option is indicated for measuring arterial, venous, intracranial and other physiological pressures on patients.

Temperature: The Temperature option is indicated for measuring temperature in patients.

The modification is a change that provides an optional Bluetooth™ wireless technology option to transfer data from the MRx to a Bluetooth enabled device. This wireless connection is an alternative to the current RS232 cable connection capability.

The provided text is a 510(k) summary for the Philips HeartStart MRx Monitor/Defibrillator Software Release 7.01. It describes a modification to an existing device, primarily the addition of an optional Bluetooth wireless technology-based data transfer.

This submission is for a modification to a previously cleared device. The summary generally focuses on asserting that the new features (Bluetooth connectivity) do not negatively impact the device's existing performance, rather than re-proving the core functionalities of the monitor/defibrillator. Therefore, many of the typical elements of an AI/algorithm-based device study (like sample sizes, ground truth, expert adjudication, etc.) are not applicable or not explicitly detailed in this type of submission for a physical device with a software update.

Here’s an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical acceptance criteria or performance metrics for the device's core functions (ECG, NBP, SpO2, defibrillation, etc.) for this particular 510(k). Instead, it states:

2. Sample Sizes Used for Test Set and Data Provenance

• Test Set Sample Size: Not specified. The testing described ("system level tests, integration tests, environmental tests, and safety testing from hazard analysis") refers to device validation and verification testing, not typically patient-based clinical trials with a "test set" in the context of an algorithm.
• Data Provenance: Not applicable in the context of an algorithm-based "test set" here. This is a hardware/software update to a medical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. Ground truth, in the sense of expert consensus for an algorithm, is not relevant for this type of device modification submission. The "ground truth" for the device's functionality would be its adherence to engineering specifications and regulatory standards.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This refers to consensus among experts, which is not relevant for the type of testing described (system, integration, environmental, safety).

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

• Was an MRMC study done? No. This type of study assesses how an AI system impacts human reader performance, which is not applicable to a non-AI device modification.
• Effect size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? No. This device is a monitor/defibrillator; its performance is not "algorithm only" in the sense of a diagnostic AI tool. The software update is for connectivity.

7. Type of Ground Truth Used

• Ground Truth Type: For the device's core functionalities, the "ground truth" would be established by reference standards, engineering specifications, and established medical diagnostics (e.g., a calibrated pressure sensor for NBP, a known electrical signal for ECG, etc.). For the Bluetooth functionality, the ground truth would be successful and reliable data transmission as per engineering specifications. The documentation does not specify the exact methods for establishing this but implies it was based on existing specifications for the predicate device.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/machine learning algorithm that requires a "training set" of data in the typical sense. The software development follows traditional engineering and validation processes.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" in the AI sense.

In summary:

This 510(k) submission (K063375) describes a software update (Release 7.01) to an existing Philips HeartStart MRx Monitor/Defibrillator, adding Bluetooth connectivity. The regulatory submission primarily relies on demonstrating substantial equivalence to predicate devices and proving that the new feature does not adversely affect the device's existing safety or effectiveness. The "study" mentioned consists of verification and validation activities (system, integration, environmental, and safety tests) against existing specifications, rather than clinical studies with patient data or AI algorithm performance evaluations. As such, many of the questions related to AI/algorithm performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies) are not pertinent to this specific regulatory filing.

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The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.

Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation.

Non-invasive External Pacing Therapy: The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

Pulse Oximetry: The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.

Non-invasive Blood Pressure Monitoring: The NBP option is intended for non-invasive measurement of a patient's arterial blood pressure.

End-tidal CO2: The EtCO2 option is intended for non-invasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.

12-Lead ECG: The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.

Q-CPR: The Q-CPR™ option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

The Q-CPR option is contraindicated as follows:

• The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less that 25 kg).
• The Q-CPR option is not for use when CPR is contraindicated.

The name of this device is the HeartStart MRx Monitor/Defibrillator with IntelliVue Networking Software Release 7.01. The modification is a change that provides network connectivity via the Philips IntelliVue Network.

The provided text describes a 510(k) summary for the HeartStart MRx Monitor/Defibrillator with IntelliVue Networking Software Release 7.01. However, it does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and study particulars.

The document states that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." This indicates that the device met the acceptance criteria based on its equivalence to a predicate device, but the specific numerical acceptance criteria and performance data are not provided.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

Explanation: The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence," and that "The results demonstrate that web software interface functionality meets all reliability requirements and performance claims." However, the exact numerical acceptance criteria (e.g., specific sensitivity, specificity, accuracy thresholds) and the corresponding reported performance values for these criteria are not provided in the given text. The focus of this 510(k) is on the network connectivity modification and its substantial equivalence to the predicate, rather than detailed performance metrics for the core defibrillator functionalities.

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

• Sample Size for Test Set: Not specified
• Data Provenance: The document mentions "system level tests, integration tests, environmental tests, and safety testing from hazard analysis." This suggests internal testing by Philips Medical Systems, but no details about the origin of patients data (if any was used for performance validation), country of origin, or whether it was retrospective or prospective are provided. The testing appears to focus on the technical functionality of the network modification and its impact on the device as a whole, rather than clinical performance on a patient dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable / Not Specified. The document describes engineering and system-level verification and validation for a network connectivity update and overall device functionality, not a study evaluating diagnostic accuracy against a ground truth established by medical experts.

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

• Not Applicable / Not Specified. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to establish ground truth for diagnostic or interpretative tasks. This document describes technical device testing.

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 device described is a monitor/defibrillator with networking software; it is not an AI-assisted diagnostic tool that would typically involve human readers evaluating results.

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

• Not Applicable. This device is a monitor/defibrillator that interacts directly with patients and is operated by medical personnel. The "performance" described relates to its overall functionality, reliability, and connectivity, not a standalone diagnostic algorithm.

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

• Based on predicate device specifications and engineering requirements. The "ground truth" for the tests described appears to be the established specifications and expected behavior based on the predicate device and design documents for the new network functionality. There is no mention of clinical ground truth (like pathology, expert consensus, or outcomes data) being used for this 510(k) submission, as the focus is on substantial equivalence of technical features and safety.

8. The sample size for the training set

• Not Applicable. The device described is a hardware and software system, not a machine learning model that requires a "training set" in the conventional sense of AI/ML development.

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

• Not Applicable. As no training set is mentioned or implied for an AI/ML model, the establishment of its ground truth is not relevant to this submission.

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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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The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.

The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.

Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation.

Noninvasive External Pacing Therapy: The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

Pulse Oximetry: The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.

Noninvasive Blood Pressure Monitoring: The NBP option is intended for noninvasive measurement of a patient's arterial blood pressure.

End-tidal CO2: The EtCO2 option is intended for monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.

12-Lead ECG: The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.

Q-CPR: The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

The Q-CPR option is contraindicated as follows:
The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less that 25 kg).
The Q-CPR option is not for use when CPR is contraindicated.

Invasive Pressure: The Invasive Pressure option is indicated for measuring arterial, venous, intracranial and other physiological pressures on patients.

Temperature: The Temperature option is indicated for measuring temperature in patients.

The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). The HeartStart MRx can also be used for ECG monitoring of a patient, non-invasive external pacing, 12-Lead ECG, non-invasive blood pressure, end-tidal CO2 (EtCO2), pulse oximetry (SpO2), Q-CPR™, invasive pressure and temperature measurements.

This 510(k) summary for the Philips HeartStart MRx Invasive Pressure Option and Temperature Option does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document states:

• "The tests used in the determination of substantial equivalence included only bench testing, Bench testing includes hardware and software testing demonstrating that the performance of the device meets its specifications." (Page 2)
• "Based on the results of the testing described above, it is concluded that the HeartStart MRx with Invasive Pressure and Temperature Options does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices. It is considered to be substantially equivalent to the predicate devices." (Page 2)

This indicates that the submission relied on bench testing to show the device met its own specifications and was substantially equivalent to predicate devices, rather than providing details on specific acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy) and a clinical or comparative study demonstrating compliance with those criteria.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication, or MRMC studies. This information is not present in the provided text.

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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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