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EOlife is intended for use with emergency manual resuscitation devices to measure ventilatory flows and display visual guide on the insufflated volume, and ventilation frequency to ensure adequate ventilation of adult cardiopulmonary arrest patient during cardiopulmonary resuscitation (CPR) performed by healthcare professionals.

EOlife is a medical device dedicated to healthcare professionals to help them providing manual ventilation during cardiopulmonary resuscitation (CPR). EOlife is intended to be connected to any standard manual resuscitator for adults including a bag and a mask or endotracheal tube (ET tube) and supraglottic airway (SGA) device and to be used during manual ventilation of an adult cardiopulmonary arrest patient. EOlife is a portable device composed of an electronic control unit including an embedded software, a removable and rechargeable battery pack and of a single use flow sensor: FlowSense. EOlife does not present direct contact with the patient. Only the ventilation air flow is in contact with the internal part of FlowSense (indirect contact with the patient). During manual ventilation, EOlife measures the ventilation parameters (insufflated volumes, tidal volumes, ventilation frequencies, ) and gives real-time feedback to the user about the quality of the ventilation provided to the patient compared to the 2020 AHA (American Heart Association) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 3: Adult Basic and Advanced Life Support. The aim is to help the user ventilate according to the recommended frequencies (10 cycles per minute) and volumes (6-8 ml/kg of ideal body weight).

The provided text describes the EOlife device, a medical device intended to assist healthcare professionals in manual ventilation during cardiopulmonary resuscitation (CPR) by measuring ventilatory flows and displaying visual guides on insufflated volume and ventilation frequency. The document is a 510(k) premarket notification by Archeon Medical to the FDA, asserting substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a "Comparison of Technological Characteristics with Predicate Device" (Table 1) and a "Summary of Performance Testing" (Table 2). The most relevant section for acceptance criteria related to product performance is the "Measuring range and accuracy of ventilation values" and "Measuring range and accuracy of ventilation frequencies" within Table 1.

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

The document explicitly states: "The subject EOlife did not require clinical studies to support substantial equivalence." Instead, it relies on non-clinical (bench) testing, usability testing, and comparison to a predicate device.

• Test Set Description: The "test set" in this context refers primarily to the testing conducted on the physical device and its software, rather than a dataset of patient cases.
• Sample Size:
  • For the performance metrics (Vi, Vt, Freq), the specific number of tests or samples used to derive the RMSE values is not provided.
  • For biocompatibility, electrical safety, EMC, battery, power supply, mechanical, and software testing, the sample size is also not explicitly stated. These types of tests typically involve a limited number of devices to demonstrate compliance with standards.
  • For usability testing, "rounds of formative and summative testing" were performed, but the number of participants or test scenarios is not specified.
• Data Provenance: The testing was related to the device itself (hardware, software). No patient data is mentioned as being used for testing. The manufacturer, Archeon Medical, is based in Besançon, France. Therefore, the testing would presumably have been conducted there or by affiliated labs.

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

This information is not provided as the submission focuses on non-clinical testing and comparison to a predicate device, not on diagnostic performance against human expert-established ground truth on a patient dataset. The "ground truth" for the device's measurements (volume, frequency) would be established by calibrated measurement equipment used in the bench testing.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no human expert-based ground truth or adjudication process described for clinical effectiveness. The assessment is against technical specifications and established standards through bench 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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "The subject EOlife did not require clinical studies to support substantial equivalence." The device is positioned as an "adjunct tool" providing real-time feedback, not as an AI diagnostic tool that human readers would interpret. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

The performance testing (bench testing) described in Table 2, specifically the "Accuracy assessment of the values measured and displayed by EOlife," can be considered a form of standalone performance assessment of the device's measurement capabilities. The software within the device operates autonomously to measure and display parameters ("algorithm only"). However, this is for measurement accuracy, not for a diagnostic or interpretive task that would typically be associated with "standalone AI performance" in imaging or other clinical decision support contexts. The device's primary function is to provide real-time guidance to a human user, making it inherently "human-in-the-loop" in its intended use.

7. The Type of Ground Truth Used:

• For the measurement accuracy of volume and frequency values during bench testing, the ground truth would be established by precision laboratory instruments and simulated ventilation profiles (e.g., using a test lung and a ventilator simulator with known, calibrated outputs).
• For biocompatibility, electrical safety, EMC, mechanical, and software validation, the ground truth is compliance with international consensus standards (e.g., ISO, IEC, UN).
• For usability, the ground truth is the successful and safe completion of critical tasks by users as assessed in human factors testing.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The EOlife device is described as having "an embedded software that contains algorithms," but the document does not indicate that these algorithms (for measuring ventilatory flows and providing guidance) were developed using machine learning or required a "training set" of data in the typical sense. It appears to be based on programmed logic and physics models rather than statistical learning from a large dataset.

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

This information is not applicable/not provided for the same reasons as point 8.

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The Propaq M system is indicated to monitor and/or record 3-, 5-, or 12-lead electrocardiogram (ECG) waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. ECG monitoring is indicated for patients from newborn (neonate) to adult, with and without heart dysfunction.

The Propaq M system is indicated for use to make non-invasive measurements of arterial pressure and to alarm if either parameter is outside of the limits set by the user. The non-invasive blood pressure is indicated for patients from newborn (neonate) to adult.

The Propaq M system is indicated for use to make continuous temperature measurements of rectal, or surface temperatures, and to alarm if the temperature is outside of the user. The temperature monitoring feature is indicated for use in patients from newborn (neonate) to adult.

The Propaq M system is indicated for use for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), pleth variability index (PVI), and perfusion index (PI) via the pulse Co-oximeter and accessories. The pulse Co-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.

The Propaq M system is indicated for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. The respiration monitoring feature is indicated for use on patients from newborn (neonate) to adult.

The Propaq M system is indicated for use in continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate. The CO2 monitoring feature is indicated for use on patients from newborn (neonate) to adult.

The Propaq M system is indicated for use to display and make continuous invasive pressure measurements via a compatible pressure transducer. The invasive pressure is indicated for use on patients from newborn (neonate) to adult.

The Propaq M system is indicated to provide graphical trend data for SpO2, Systolic BP (SBP) and EtCO2 as well as ventilation assistance relevant to the management of a TBI patient.

The Propaq M system is indicated for use in acquiring, and reporting physiological data via 12-lead ECG Analysis, and to provide interpretation of the data for consideration by caregivers. The 12-lead ECG Analysis feature is indicated for use on adults (> 18 years of age).

The Propaq M system is indicated for the remote display of physiological data displayed on connected Propaq M systems via the Web Console feature, including electrocardiogram (ECG), non-invasive blood pressure (NIBP), temperature, and heart rate.

The proposed ZOLL® Propag® M is a portable monitor designed for use by trained medical personnel who are familiar with basic monitoring and vital signs assessment. In the currently cleared configuration, the ZOLL® Propaq® M provides monitoring capabilities for ECG, Pulse CO-Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), End Tidal CO2, Temperature, and Respiration. The device is powered by an auxiliary power supply or an easily replaced battery pack that is quickly recharged in the device when it is connected to the auxiliary power supply. The product is designed for use in hospital. EMS, and rugged military environments. The unit has a large colorful LCD display of numerics and waveform data that provides easy visibility from across the room and at any angle. ECG, plethysmograph, and respiration waveform traces can be displayed simultaneously, providing easy access to all patient monitoring data at once. The display screen is configurable to allow the best visual layout according to monitoring needs. The Propaq® M has a patient data review and collection system that allows the user to view, store, and transfer patient data. The Propaq® M unit contains a USB port, which the user can use to transfer data to a PC and, optionally, a printer, which can be used to print patient data. The Propaq® M unit can send data through a wireless connections. The unit can send 12lead report snapshots (including trend data) or disclosure logs to a recipient via a ZOLL® server. In addition, full disclosure cases, which also contain trend data, can be automatically retrieved from the Propaq® M unit using ZOLL® RescueNet® or ePCR software. Propaq® M models use an easily replaced rechargeable lithium-ion battery pack (the SurePower II Battery Pack). A new, fully charged battery pack typically delivers more than 8 hours of ECG monitoring. Use of other functions (such as higher screen brightness or shorter NIBP intervals) reduces this time. A clinical dashboard for monitoring patients with suspected traumatic brain injury (TBI) has been added as part of Software Version 02.34 of the proposed Propaq® M device. The TBI Dashboard was initially cleared for ZOLL® X Series® (K141774) to be displayed on a separate mobile device that connects to the main device (ZOLL® X Series®) via Bluetooth. The proposed feature is to display the TBI Dashboard directly on the Propag® M device via Software 02.34. The TBI Dashboard presents the user with graphical trend plots of 3 different parameters - (1) 15 minutes of systolic blood pressure (SBP), (2) 3 minutes of oxygen saturation of arterial hemoglobin (SpO2), and (3) 3 minutes of carbon dioxide concentration of the expired breath (EtCO2). The proposed ZOLL® Propaq® M device already provides this information in tabular format and in the live parameter boxes. The TBI Dashboard groups the information on one screen in a graphical format. The trend graphs display supervisor-configurable limits to allow the user to monitor patient parameters based on their local protocols. These protocol limits only appear in Adult mode. There is also a ventilation panel available on the TBI Dashboard to assist the user with manual ventilations. The TBI Dashboard allows the user to modify the target ventilation rate, the scale of each graphical trend, and to turn the ventilation timer and prompt on or off. Software Version 02.34 introduces automatic retries of failed 12-Lead report transmissions. While legacy Software of the Propaq® M attempts transmission of the 12-Lead report only once, the new proposed Software Version 02.34 attempts re-transmission up to five times if the initial attempt fails. This feature is a non-clinical enhancement since it affects only an external communication feature of the device with no impact to the acquiring, analyzing, or reporting process of ECG data. The Propaq® M device is an alternate configuration of the ZOLL® X Series® device that depopulates the defibrillator/pacer module circuitry. Removal of this circuitry also removes CPR Monitoring capability from the device as the sensor that enables the CPR feature resides in the defibrillation electrodes. Physical changes to the proposed Propaq® M device are limited to removing the defibrillator and pacer modules, removing the defibrillator and pacer controls from the front keypad, and changing the color scheme of the device. The remaining features and functions of the proposed Propaq® M device are identical to the existing ZOLL® X Series® model. In order to simulate the functioning of the Propag® M device, a regression testing was conducted on the X Series device by disabling the defibrillator/pacer module, which ensures the effective functioning of the proposed Propag® M device.

The ZOLL Propaq M device received 510(k) clearance (K202375) and is a portable patient monitor indicated for various physiological monitoring functions including ECG, SpO2, Non-Invasive Blood Pressure, Invasive Blood Pressure, End Tidal CO2, Temperature, Respiration, 12-Lead Analysis, and a new TBI Dashboard feature. The submission focuses on the substantial equivalence of the modified Propaq M (with Software Version 02.34 incorporating the TBI Dashboard and 12-Lead re-transmission) to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter for K202375 does not explicitly list acceptance criteria in a quantitative table format for the device's overall performance. Instead, the clearance is based on the device meeting various recognized standards and demonstrating substantial equivalence to predicate devices through technical comparisons and verification/validation testing. The key additions covered by this submission are the TBI Dashboard and 12-Lead transmission retry enhancement.

Since specific numerical acceptance criteria for the TBI Dashboard and 12-Lead re-transmission were not provided as such in the given document, the table will reflect the types of performance assessments conducted and the outcome in terms of meeting requirements.

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

The document does not explicitly state a sample size for a distinct "test set" in the context of diagnostic accuracy or a clinical trial for the TBI Dashboard or 12-Lead re-transmission. Instead, the testing appears to be primarily non-clinical for these specific software enhancements.

• TBI Dashboard & 12-Lead Re-transmission: The evaluation revolved around software verification and validation (V&V) through regression testing on the X Series device (which encompasses the Propaq M's functionalities with defibrillator/pacer module disabled) and usability testing. The sample sizes for these V&V activities are not explicitly detailed in the provided text.
• Data Provenance: The document does not specify country of origin for any data related to these specific updates. The testing described (software V&V, safety, EMC, usability) are typically internal company processes. The submission refers to prior clearances for the predicate devices (K180482, K141774, P160022/S013), suggesting the data originates from previous testing submissions for those devices.

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

This information is not provided in the document. The TBI Dashboard update primarily involves displaying existing physiological data in a new graphical format and providing ventilation assistance. The 12-Lead re-transmission is a technical enhancement. Ground truth for these features would typically be established through engineering specifications, software requirements, and expert review within the development process, rather than a clinical "ground truth" derived from patient data by independent medical experts for performance validation.

4. Adjudication Method for the Test Set

This information is not provided as the submission focuses on non-clinical testing for software updates and substantial equivalence, not a clinical study requiring adjudication of expert interpretations against ground truth.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or mentioned in the provided text for the TBI Dashboard or 12-Lead re-transmission features. The submission states, "Clinical evidence was not necessary to show substantial equivalence." The improvements are primarily in data presentation and system reliability, not diagnostic accuracy requiring human reader comparison.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for the algorithm of the TBI Dashboard or 12-Lead re-transmission, separate from the human-in-the-loop, was not explicitly detailed. The TBI Dashboard is a display feature and ventilation assistance tool presenting existing physiological data. The 12-Lead re-transmission is a software function to improve data transfer reliability. Their performance is assessed through software verification and validation, as well as usability testing, which inherently involves human interaction with the device.

7. Type of Ground Truth Used

For the software updates (TBI Dashboard and 12-Lead re-transmission), the "ground truth" implicitly used is:

• Engineering Specifications and Software Requirements: The device's performance is validated against its pre-defined functional and performance specifications.
• Existing Physiological Data Streams: The TBI Dashboard utilizes existing, cleared physiological monitoring parameters (SpO2, SBP, EtCO2) from the Propaq M. The "ground truth" for these underlying parameters would have been established in previous clearances. The TBI Dashboard's "truth" is the faithful and accurate graphical representation of these established data streams.

8. Sample Size for the Training Set

The document does not mention a training set sample size because the TBI Dashboard and 12-Lead re-transmission are not described as machine learning or AI models that require a distinct "training set" in the conventional sense. They are software features that process and display data based on predefined rules and algorithms.

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

As no training set is described for these specific features (TBI Dashboard and 12-Lead re-transmission), this question is not applicable.

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The G5 Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response.

An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Postresuscitation, if the patient is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver a shock, or for an automatic AED, automatically deliver a shock if needed.

When a patient is a child up to 8 years of age, or up to 25kg (55 lbs), the AED should be used with the Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient's exact age or weight.

The optional CPR Device offers CPR performance feedback to aid a trained rescuer by providing compression rate and depth performance feedback through audio prompting. The CPR Device is indicated for use on cardiac arrest patients 8 years of age or older, or who weigh more than 25 kg (55 lbs).

The Powerheart® G5 AED is a portable, battery operated, self-testing defibrillator used to diagnose and treat life threatening ventricular arrhythmias in patients who are unresponsive and not breathing or not breathing normally. This is accomplished by monitoring the patient's ECG and delivering a defibrillation shock if necessary.

The AED is intended to be used by a person designated within a community, locale or building who is the first responder to a medical emergency. This typically includes ambulance, police or fire fighting personnel, emergency response team members, security personnel, and lay persons who have been trained in CPR and in the use of the AED.

The Powerheart® G5 AED guides the user through a rescue using voice or text prompts. Defibrillation pads are used to monitor and defibrillate patients. Defibrillation pads, meant for patients older than 8 years or heavier than 55 lb, are preconnected to the Powerheart G5 AED and placed in two locations on the patient during a rescue. Pediatric pads are connected to the AED when a pediatric patient is involved and meant for use on those patients 8 years or younger, or 55 lb or lighter.

The Powerheart® G5 CPR Device (CPRD), used in conjunction with the G5 AED, is a single use tool that provides CPR performance feedback to aid a CPR trained rescuer in the performance of CPR. The CPRD provides compression rate and depth audio feedback. CPR measurements are recorded for post-event review.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powerheart G5 AED with optional CPR device:

Acceptance Criteria and Device Performance for Powerheart G5 AED with CPR Device

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test set used in the functional, software, hardware, or human factors studies.

• Test Set Description:
  • Functional/Software/Hardware Testing: No specific number of test cases or data points is mentioned. The description suggests comprehensive testing (white box, black box, unit, integration).
  • Human Factors: "Each participant" implies a finite number of individuals, but the exact count is not provided.
• Data Provenance: Not specified. The studies appear to be internal company evaluations, so the data would be proprietary/internal. No mention of country of origin or whether it's retrospective or prospective is made.

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

The document does not describe the use of external experts for establishing ground truth within the context of these engineering and human factors tests. The ground truth for functional, software, and hardware performance would typically be established based on engineering specifications, industry standards, and internal quality assurance protocols. For human factors, the success criteria (e.g., proper application, no delay/distraction) would have been predefined by the study designers.

4. Adjudication Method for the Test Set

No adjudication method is described, as the studies are primarily technical performance and human factors evaluations rather than diagnostic accuracy studies requiring multiple expert interpretations.

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

No MRMC comparative effectiveness study is mentioned. The evaluation focuses on the safety and effectiveness of the device itself and its substantial equivalence to predicate devices, not on the improvement of human readers' performance with AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

The device, an Automated External Defibrillator (AED), inherently operates with significant automated functions (ECG analysis, shock advisory/delivery). The studies described are implicitly evaluating the standalone performance of these automated functions (software and hardware evaluation). The human factors test evaluates the interaction with the human user, not the delegation of diagnostic tasks from a human to the algorithm, or the improvement of the human's diagnostic ability. Therefore, yes, standalone (algorithm-only) performance was assessed for the core AED functionality.

7. Type of Ground Truth Used

• Functional/Software/Hardware: The ground truth for these tests is based on engineering specifications, design requirements, and industry standards (e.g., for defibrillation accuracy, timing, CPR feedback parameters). Tests aim to verify that the device's output matches these predefined correct behaviors.
• Human Factors: The ground truth for the human factors study would be pre-defined success criteria for proper device usage and the absence of factors delaying or distracting rescuer performance.

8. Sample Size for the Training Set

No information about a training set for an AI/machine learning model is provided. This device is an AED with CPR feedback, and the description of its software evaluation does not indicate the use of machine learning that would require a distinct "training set" in the context of predictive algorithms. The software validation is traditional verification and validation against requirements and design.

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

As no training set is mentioned in the context of machine learning, this question is not applicable based on the provided document.

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• Defibrillation
• ECG Monitoring
• Cardioversion ●
• CPR Feedback ●

The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules:

• AED Pro
• M Series ●
• E Series ●
• R Series ●

The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including:

• . Physicians
• Nurses
• Paramedics
• Emergency Medical Technicians ●
• Cardiovascular Laboratory Technicians
• First Responders

The CPR Dura-padz Reusable Defibrillation Electrodes are not for use with ZOLL AED Plus and/or any Public Access Defibrillators.

The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

As with the cleared predicate device (K100565), the CPR Dura-padz Reusable Defibrillation Electrode is intended for use with the following ZOLL biphasic-only defibrillators: AED Pro, E Series, R Series and M Series for ECG monitoring, defibrillation and cardioversion. The addition of a CPR sensor (cleared per K110742) to the subject device will enable CPR feedback. As with the currently marketed predicate device (K100565), the CPR Dura-padz electrode is intended for use in conjunction with Dura-padz Gel on adult patients, and the electrode is reusable up to 100 patient uses.

The provided text does not contain specific acceptance criteria for a device, nor does it describe a study detailing the device's performance against such criteria. The document is a 510(k) premarket notification for the "CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel," which is an FDA submission for substantial equivalence to legally marketed predicate devices.

Instead of acceptance criteria and device performance, the document states:

• "Substantial Equivalence - Non-Clinical Evidence:" "Safety, efficacy and substantial equivalence was shown through verification and validation testing." And earlier: "The existing features and functions (defibrillation, cardioversion and ECG monitoring) of the CPR Dura-padz Reusable Defibrillation Electrode have been cleared per K100565. ... The CPR Feedback monitoring function is the same technology used in the predicate device cleared per K110742."
• "Substantial Equivalence - Clinical Evidence: N/A - Clinical evidence was not necessary to show substantial equivalence."
• "Performance Testing:" "The CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel has been subjected to extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards. Performance testing is provided in Section 18 of this submission."

Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document refers to "Section 18 of this submission" for performance testing details, which is not included here. The core of this FDA submission is to demonstrate equivalence to existing devices (K100565 and K110742) rather than presenting a novel study against specific, new acceptance criteria.

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• Defibrillation
• Cardioversion
• Noninvasive Pacing
• ECG Monitoring
• CPR Feedback
  For use with ZOLL® Defibrillators, such as:
• R Series
• X Series
  Trained Personnel only, Including:
• Physicians
• Nurses
• Paramedics
• Emergency Medical Technicians
• Cardiovascular Laboratory Technicians
  The OneStep Pediatric CPR electrodes are indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

As with the currently marketed OneStep Pediatric CPR Multi-Function Electrode (reviewed and cleared with K120907), the modified OneStep Pediatric CPR Multi-Function Electrode (MFE) is intended for use with ZOLL R Series and ZOLL X Series defibrillators for ECG Monitoring, Defibrillation, External Noninvasive Pacing, Cardioversion and CPR Feedback for use on patient less than 8 years of age or weighing less than 55lbs (25kg) in either the hospital environment. The currently marketed OneStep Pediatric CPR MFE provides users with accurate depth compression feedback when CPR is performed on a firm surface – a known recommended practice. A recent publication by the AHA acknowledges that "accelerometers are insensitive to mattress compression" and stresses the need for "continued development of optimal and widely available CPR monitoring." So. with the current submission. we are proposing to modify the OneStep Pediatric CPR MFE to incorporate a second motion sensor on the posterior electrode thereby allowing rescuers to obtain accurate depth compression feedback when CPR is performed on soft/ compressible surfaces. Dual sensor technology, utilized in the proposed OneStep Pediatric CPR MFE. has been reviewed and cleared by the agency with OneStep CPR II MFE (K133441).
As with the predicate device, the proposed electrode and wire harness with a ZOLL proprietary connector will have a pre-connect feature that enhances the user's ability to deliver immediate therapy. And like the predicate device, the OneStep Pediatric CPR electrode is also designed to support the defibrillator's self test and expiration date identification. Each electrode pad is structurally comprised of a solid hydrogel with a pure tin electrical conductive element having a polyethylene terephtalate (PET) backing with an adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment.

The provided text is a 510(k) summary for the ZOLL OneStep Pediatric CPR Multi-Function Electrode (MFE). It describes a modified device that incorporates a second motion sensor for improved CPR depth feedback on soft surfaces. However, it does not explicitly provide a table of acceptance criteria or detailed results of a study proving the device meets specific performance metrics in the way that would typically be presented for image-based diagnostic or AI-driven medical devices.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical evidence and performance testing against recognized standards. There is no mention of a study involving human readers or AI in the context of diagnostic accuracy.

Therefore, many of the requested elements cannot be extracted directly from this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) for a diagnostic outcome, nor does it present device performance in that manner. Instead, it states that the device was subjected to "extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards."

The performance testing listed consists of categories rather than specific metrics:

• EMC Testing in accordance with IEC 60601-1-2.
• Electrical, mechanical, bio-compatibility and simulated use testing per the applicable requirement of international recognized standards IEC 60601-1, IEC 60601-2-4, ISO 10993-1, ISO 10993-5 and ISO 10993-10.
• Testing to qualify the use of the electrode with R Series and X Series devices.
• Usability testing.

The "reported device performance" is essentially that these tests were conducted and the device met its functional requirements and specifications, allowing it to be deemed substantially equivalent.

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

The document does not refer to a "test set" in the context of diagnostic performance data (e.g., medical images or patient records). The "testing" mentioned refers to engineering and safety performance tests of the device itself (electrical, mechanical, usability). Therefore, sample sizes for such a test set and data provenance (country, retrospective/prospective) are not applicable or provided in this context.

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

This information is not applicable. The device is a multi-function electrode for CPR and defibrillation, not an interpretative diagnostic tool. Ground truth in the sense of expert consensus on diagnostic findings is not relevant to the described testing.

4. Adjudication Method:

Not applicable, as there's no diagnostic ground truth being established.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is compared with and without AI assistance. This document describes a physical medical device (electrodes) and its substantial equivalence based on engineering and safety performance, not a diagnostic algorithm.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone algorithm performance study was not done. The device in question is a hardware component with a function to provide feedback (CPR depth), not an independent algorithm for diagnostic interpretation.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing described would be the verifiable measurements and standards for electrical safety, biocompatibility, mechanical integrity, and functional performance (e.g., accurate depth compression feedback as measured by a calibrated system). It is not expert consensus, pathology, or outcomes data in the diagnostic sense.

8. Sample Size for the Training Set:

Not applicable. The device is not an AI/ML algorithm that requires a training set of data.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary regarding acceptance criteria and study in the context of the provided document:

The provided document describes the ZOLL OneStep Pediatric CPR Multi-Function Electrode and seeks 510(k) clearance by demonstrating substantial equivalence to existing predicate devices.

Instead of providing a typical "acceptance criteria" table with specific performance metrics for a diagnostic claim, the document indicates that acceptance was based on the device meeting functional requirements and performance specifications as defined by applicable National/International recognized standards.

The study (or rather, "performance testing") used to demonstrate this involved:

• EMC Testing: In accordance with IEC 60601-1-2.
• Electrical, Mechanical, Biocompatibility, and Simulated Use Testing: Per IEC 60601-1, IEC 60601-2-4, ISO 10993-1, ISO 10993-5, and ISO 10993-10.
• Device Qualification Testing: To ensure compatibility with ZOLL R Series and X Series defibrillators.
• Usability Testing.

The primary change being approved is the addition of a second motion sensor to improve CPR depth feedback on soft surfaces, a technology already cleared in a similar predicate device (OneStep CPR II MFE, K133441). Clinical evidence was explicitly stated as "N/A - Clinical evidence was not necessary to show substantial equivalence." This indicates that the regulatory decision was based on engineering and performance testing against established standards for physical devices, rather than a clinical trial or diagnostic performance study.

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The HeartSine samaritan® PAD 450P (also known as SAM 450P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs:

• . Unconscious
• Not breathing .
• . Without circulation

The samaritan® PAD 450P is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program.

The samaritan® PAD 450P is indicated for use on patients greater than 8 years old or over 55 lbs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 450P is indicated for use on children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).

Like the SAM 350P predicate device, the SAM 450P is a small, lightweight portable battery operated Automated External Defibrillator (AED) designed to treat victims of a cardiac arrest. The SAM 450P incorporates a simple user interface of voice and text/icon prompts to guide the user in the use of the device.

Like the SAM 350P predicate device, the SAM 450P incorporates an audible metronome to guide the user as to the correct rate at which chest compressions should be administered in accordance with current AHA resuscitation quidelines. However, in addition to the metronome provided in the SAM 350P, the SAM 450P also includes a proprietary impedance cardiogram (ICG) analysis algorithm to determine the rate at which CPR compressions are being administered. The SAM 450P uses the measured CPR compression rate to provide both audible and visual feedback prompts to the user to quide them to administer compressions at a rate within the current AHA resuscitation quidelines (i.e., 100-120 compressions per minute). The SAM 450P's audible and visual feedback prompts take the form of voice prompts such as "Push Faster", "Push Slower", and "Good Speed" and LEDs in red, amber and green being lit on the device cover to indicate if the speed at which the compressions are being delivered is too fast, too slow or within the guideline recommendations.

Like the SAM 350P predicate device, the proprietary SAM 450P ECG analysis algorithm automatically determines whether a victim has a shockable or nonshockable rhythm and advises a shock when appropriate. If a shock is required, the SAM 450P will automatically charge to the appropriate energy level and prompt the user to press the illuminated shock button. This enables the delivery of therapeutic energy to the patient.

Like the SAM 350P predicate device, an escalating, truncated exponential biphasic waveform pulse is delivered to the patient via two disposable defibrillator electrodes. This waveform is known as SCOPE® (Self-compensating Output Pulse Envelope). A 150 Joule, 150 Joule, 200 Joule escalating energy sequence is used in accordance with current AHA resuscitation quidelines.

After initial analysis and shock delivery (if appropriate), the SAM 450P will advise that CPR may be commenced via a number of voice prompts such as "Begin CPR" and "It is safe to touch the patient" in addition to emitting an audible metronome.

Like the SAM 350P predicate device, the SAM 450P records the patient's electrocardiogram (ECG) and the patient's ICG (Impedance Cardiogram). The ECG can be viewed using HeartSine's Saver EVO® software.

The Pad-Pak is a combined battery and electrode unit which is single use. The electrodes used with the SAM 450P are two non-sterile, single-use, self-adhesive, conductive gelled defibrillation electrodes. The Pad-Pak is available in three versions: an adult version, a paediatric version, and an adult version meeting FAA temperature, shock and flammability requirements for use on commercial aircraft. The Pad-Paks are identical to those cleared under K123881 for the SAM 350P.

Like the SAM 350P predicate device, the SAM 450P incorporates the following features:

• . Controls for Power ON/OFF and Shock
• Automated charging at escalating energies of 150J, 150J, 200J ●
• Automated self-tests and LED status indicator ●
• Combined, disposable battery and electrodes (Pad-Pak™)
• Electrode placement guidance voice prompts and LED/icon indicators
• CPR voice prompts and metronome ●
• Paediatric function for victims between the ages of 1 and 8 years at non-● escalating energy of 50 J
• Integral event data recording .

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the HeartSine samaritan® PAD 450P, formatted as requested:

Acceptance Criteria and Device Performance

Study Details

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

• Arrhythmia Diagnostic Algorithm Validation: Standardized AHA, MIT, and CU databases were used. The document does not specify the sample size (number of ECGs) from these databases or their specific provenance.
• CPR Rate Feedback (Animal Study): The document does not specify the sample size (number of animals or data points). It was a GLP (Good Laboratory Practice) animal study, implying prospective data collection under controlled conditions. The country of origin for the data is not specified.
• Usability Study: The document does not specify the sample size (number of participants/users). It was a usability study, implying prospective data collection. The country of origin for the data is not specified.

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):

• Arrhythmia Diagnostic Algorithm: For standardized databases like AHA, MIT, and CU, ground truth is typically established by multiple cardiologists or experts in electrophysiology through consensus based on detailed ECG review, sometimes supplemented by clinical outcomes. The document does not specify the number or qualifications of experts involved in the creation of these databases, only that the databases were used.
• CPR Rate Feedback (Animal Study): Ground truth for actual CPR compression rate was determined by "video recordings." The document does not mention human experts establishing this ground truth, implying direct measurement from video.
• Usability Study: Ground truth for time to first shock and usability of CPR feedback prompts would be based on observational data and potentially user feedback/surveys. The document does not specify experts establishing ground truth, rather it's data collected during the study.

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

• The document does not describe a specific adjudication method for any of the studies, particularly concerning expert review of data. Ground truth for the algorithm validation relied on pre-existing standard databases.

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, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI assistance was not explicitly described or performed based on the provided text.
• The usability study assessed the "usability of the new CPR feedback prompts," which implies assessing human performance with the device's feedback guidance, but it's not described as a formal MRMC study comparing performance with and without AI (or the device's specific CPR feedback).

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

• Yes, a standalone evaluation of the arrhythmia diagnostic algorithm was done. The document states it was "extensively validate[d]... using standardised AHA, MIT and CU databases." This is a validation of the algorithm's performance independent of a human user.
• The CPR rate feedback algorithm component's accuracy was also evaluated in the animal study by comparing its output to actual compression rates determined by video recordings, suggesting a standalone assessment of its accuracy.

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

• Arrhythmia Diagnostic Algorithm: Ground truth was established by the standardized AHA, MIT, and CU databases, which typically rely on expert consensus over detailed ECG analysis and sometimes clinical correlation.
• CPR Rate Feedback (Animal Study): Ground truth for the actual CPR compression rate was determined by "video recordings" of the compressions.
• Usability Study: Ground truth for "time to first shock" and "usability" would be directly observable metrics and subjective feedback from participants.

8. The sample size for the training set:

• The document does not specify the sample size for any training set. It refers to validation of an algorithm (arrhythmia detection) that is "unchanged from the predicate device," implying its development and training (if any) occurred previously. For the CPR feedback algorithm, training specifics are not provided.

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

• The document does not provide details on how the ground truth for any training set was established, as it does not explicitly describe a training phase for a new algorithm in detail. The arrhythmia diagnostic algorithm was carried over from the predicate device, implying its ground truth establishment (if it was a machine learning algorithm) occurred during the development of the predicate device or a previous iteration. The CPR feedback algorithm is described as a "proprietary impedance cardiogram (ICG) analysis algorithm" but details on its training and ground truth establishment are absent.

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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 in 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 suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.

Manual Defribillation: 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 certain atrial and ventricular arrhythmias.

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.

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

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

The Philips HeartStart XL+ with End-Tidal Carbon Dioxide Monitoring Defibrillator/Monitor is a modification of the FDA cleared HeartStart XL+ Defibrillator/Monitor. This function of the XL+ modification is to measure the partial pressure of carbon dioxide in a sample of the patient's exhaled breath. The HeartStart XL+ may be used to monitor carbon dioxide in both intubated and non-intubated patients.

The partial pressure of carbon dioxide is derived by multiplying the measured carbon dioxide concentration with the ambient pressure. From the partial pressure measurement, the end-tidal carbon dioxide (EtCO2) is derived.

EtCO2 is the peak CO2 value measured during expiration. It is used to monitor the patient's respiratory status. The EtCO2 measurement uses a technique based on the absorption of infrared radiation by some gases. It indicates the change in:
· The elimination of CO2.
• The delivery of O2 to the lungs.

The CO2 monitoring function of the HeartStart XL+ provides an EtCO2 value, a CO2 waveform (Capnogram), and an airway respiration rate (AwRR). The AwRR relies on CO2 functionality to identify valid breaths for numeric display and alarm conditions such as Apnea.

The provided document is a 510(k) summary for the Philips HeartStart XL+ Defibrillator/Monitor with End-Tidal CO2 Monitoring. It describes the device and its intended uses, but it does not contain a study or acceptance criteria related to a specific AI algorithm's performance in a diagnostic or predictive capacity.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards for the overall defibrillator/monitor device, not a specific AI component or a study proving its AI components meet acceptance criteria.

Therefore, many of the requested elements about an AI study cannot be extracted from this document, as it doesn't describe such a study.

Here's what can be extracted based on the provided document:

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

The document lists various IEC and EN ISO standards that the device was tested against. The "reported device performance" is a general statement that "The non-clinical testing was completed with passing results according to its Pass/Fail criteria." Specific numerical performance metrics against acceptance criteria for each standard are not detailed in this summary.

Regarding the device's End-Tidal CO2 function, the document describes its mechanism rather than performance metrics:

• "The partial pressure of carbon dioxide is derived by multiplying the measured carbon dioxide concentration with the ambient pressure. From the partial pressure measurement, the end-tidal carbon dioxide (EtCO2) is derived."
• "EtCO2 is the peak CO2 value measured during expiration. It is used to monitor the patient's respiratory status."
• "The EtCO2 measurement uses a technique based on the absorption of infrared radiation by some gases."
• "The CO2 monitoring function of the HeartStart XL+ provides an EtCO2 value, a CO2 waveform (Capnogram), and an airway respiration rate (AwRR)."

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

• Not applicable / Not provided. The document states, "No clinical studies were necessary to demonstrate substantial equivalence." The testing mentioned is non-clinical (bench testing) against standards. There is no test set of patient data described for an AI algorithm.

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 provided. No clinical studies or ground truth establishment by experts are described for an AI component.

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

• Not applicable / Not provided.

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. The document explicitly states: "No clinical studies were necessary to demonstrate substantial equivalence." There is no mention of an MRMC study or AI assistance for human readers. The device itself (HeartStart XL+ Defibrillator/Monitor) is the subject, not an AI component assisting human interpretation.

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

• Not applicable / Not provided. The device is a "Defibrillator/Monitor" intended for use by "qualified medical personnel." It's an integrated medical device, not a standalone AI algorithm being evaluated for human-in-the-loop or standalone performance. The document describes the technical function of CO2 monitoring, which is a physical measurement, not an AI algorithm.

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

• Not applicable / Not provided.

8. The sample size for the training set

• Not applicable / Not provided.

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

• Not applicable / Not provided.

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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 as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team. Do not use the unit's AED function on patients under 8 years of age.

Use of the E 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 these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In Manual mode, the E Series unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate. The Advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).

The E Series AED unit is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation.

The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.

This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradvcardia might be expected, Suppression of tachycardia.

This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP). ECG monitoring is performed by connecting the patient to the 3 or 5 lead patient cable, MFE Pads, or through the paddles. SpO2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpCO monitoring is indicated for detecting carbon monoxide concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpMet monitoring is indicated for detecting oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients. 12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction or other cardiac arrhythmias. NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.

The ZOLL E Series® Defibrillator, reviewed and cleared by FDA under premarket notification K111594, is designed for all emergent care situations and provides multiparameter monitoring of patients in critical care and transport. The ZOLL E Series combines defibrillation, CPR feedback, ECG monitoring, noninvasive transcutaneous pacing, pulse oximetry (SpO2), end tidal CO2 (EtCO2), 12-Lead ECG monitoring, noninvasive blood pressure measurement and data printing and recording in a single instrument.

The previously cleared Shock Conversion Estimator (SCE), initially reviewed and cleared by the agency under K072923, utilizes Shock Predictive (SPI) as a parameter in the shock advisory algorithm. Shock Predictive Index number is also called "Amplitude Spectral Area (AmSA) value" of the ECG Waveform, developed by the Weil Institute of Critical Care Medicine. In the previously cleared version of the E-Series, when the E Series device is configured to enable the Shock Conversion Estimator (SCE) function, the software compares the calculated Shock Predictive Index (AmSA) against a userconfigurable threshold during shock advisory rhythm analysis. If the rhythm is shockable and the computed index is greater-than or equal-to the pre-configured threshold, the shock advisory algorithm will then issue a "Shock Advised" prompt to the user. If the Shock Predictive Index (AmSA) is less-than the threshold, the shock advisory algorithm will then issue a "Continue CPR" prompt to the user.

With the current application, we are proposing a software revision that will enable the E Series device to display the calculated Shock Predictive Index (AmSA) when used in manual mode with CPR defibrillation electrodes. After the trained rescuer has confirmed the ECG rhythm by manually analyzing the characteristics of the ECG waveform, the rescuer may utilize the displayed Shock Predictive Index (AmSA) value to perform the same function as the Rhythm Analysis Function Shock Conversion Estimator (SCE), reviewed and cleared by the agency under K072923.

This document describes a 510(k) premarket notification for a software revision to the ZOLL E Series Defibrillator, specifically enabling the display of the Shock Predictive Index (AmSA) in manual mode. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, many of the requested categories (like extensive clinical studies with specific sample sizes, ground truth adjudication, or MRMC studies) are explicitly stated as "Not Applicable" or implicitly not performed as the primary evidence relies on non-clinical software verification and validation, alongside literature support for the underlying AmSA concept.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly mentioned for specific clinical data in this submission. The "test set" primarily refers to software verification and system-level validation, rather than a traditional patient-based clinical study.
• Data Provenance: Not applicable for a separate test set as the primary evidence relies on non-clinical software testing and validation. The literature cited for AmSA would have their own data provenance.

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 as the submission focuses on software verification and system-level validation for a software update, rather than a clinical study requiring expert-established ground truth on patient data for the new specific functionality (displaying AmSA). The underlying concept of AmSA and its use as a predictor of defibrillation success would have been established and validated in the scientific literature cited.

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

• Not applicable. The validation method for this software update is described as "software verification and system level validation," which typically involves engineering and quality assurance processes against predefined requirements, rather than clinical adjudication on patient cases.

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 MRMC comparative effectiveness study was done. Clinical evidence was explicitly stated as "N/A - Clinical evidence was not necessary to show substantial equivalence." The device provides information (AmSA) to the human operator, who then makes a decision; the study does not compare human performance with vs. without this specific display.

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

• The original Shock Conversion Estimator (SCE), cleared under K072923, was an "algorithm only" function that issued a "Shock Advised" or "Continue CPR" prompt. The current software revision allows the human operator to manually perform the function by interpreting the displayed AmSA value. Therefore, a standalone (algorithm only) performance study of this new manual interpretation functionality was not conducted, as the intent is human-in-the-loop.

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

• For the new functionality (displaying AmSA for manual interpretation), a clinical "ground truth" involving patient outcomes was not specifically established or documented in this submission. The ground truth for the concept of AmSA as a predictor of defibrillation success is derived from the scientific literature cited, which would have based findings on various methods including clinical outcomes. For the software itself, the "ground truth" during verification and validation would be adherence to software requirements and specifications.

8. The sample size for the training set

• Not applicable. This submission is for a software revision to display an already calculated parameter; it does not describe a new algorithm requiring a training set in the machine learning sense. The AmSA calculation itself was presumably developed and validated in prior efforts as referenced by existing predicate devices and literature.

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

• Not applicable, as there was no new training set for a new algorithm described in this submission.

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Manual Defibrillation:
Indications: Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as idioventricular or ventricular escape rhythms, and in the treatment of asystole.

Automated External Defibrillation:
Indications: AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.

Noninvasive Pacing:
Indications: Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.

12-lead Electrocardiography:
Indications: The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST-elevation myocardial infarction (STEMI).

Pulse Oximetry:
Indications: Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SpO2 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions.

Noninvasive Blood Pressure Monitoring:
Indications: Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance.

End-Tidal CO2 monitoring:
Indications: EtCO2 monitoring is used to detect trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.

Invasive Pressure Monitoring:
Indications: Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis.

Temperature Monitoring:
Indications: Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.

The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LIFEPAK 15 monitor/defibrillator was designed for use in a variety of hospital and pre-hospital settings including emergency rooms, catheterization laboratories, electrophysiology laboratories, crash carts, operating rooms, and ground ambulances. Features of the LIFEPAK 15 monitor/defibrillator include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-lead. 7-lead and interpretive 12-Lead), pulse oximetry (SpO2, SpCO, and SpMet), synchronized cardioversion, noninvasive blood pressure monitoring, end-tidal CO2 monitoring, invasive pressure monitoring, and temperature monitoring. The LIFEPAK 15 monitor/defibrillator is powered by rechargeable lithium-ion batteries or from AC power sources via an AC power adapter or DC power sources via a DC power adapter. The primary difference between the proposed LIFEPAK 15 monitor/defibrillator and the previously cleared predicate device is a combination of software and hardware modifications completed to support component obsolescence. The proposed LIFEPAK 15 monitor/defibrillator includes the same monitoring features, defibrillation waveform, pacing waveform, and Shock Advisory System™ algorithm as the previously cleared predicate device. Additionally, there are no changes to the intended use or indications for use of the previously cleared predicate device.

The provided text is a 510(k) Premarket Notification for the Physio-Control LIFEPAK 15 monitor/defibrillator. The document focuses on demonstrating substantial equivalence to a previously cleared device, primarily due to software and hardware modifications for component obsolescence. It does not provide detailed acceptance criteria or a specific study demonstrating performance against such criteria for the entire device's functionalities in the context of an AI/algorithm-driven medical device submission.

However, based on the information provided regarding the "Shock Advisory System™ algorithm," we can infer the aspects that would typically involve performance criteria for an automated external defibrillator (AED) algorithm.

Here's an attempt to answer your questions based on the available information, noting that much of the specific detail for AI/algorithm performance is not present in this 510(k) submission, as it predates the widespread regulatory focus on standalone AI algorithm performance studies. The Shock Advisory System™ algorithm mentioned is likely a rule-based algorithm rather than a modern AI/ML algorithm.

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

The document states: "The proposed LIFEPAK 15 monitor/defibrillator includes the same monitoring features, defibrillation waveform, pacing waveform, and Shock Advisory System™ algorithm as the previously cleared predicate device."

This implies that the performance of the Shock Advisory System™ algorithm is assumed to be equivalent to the predicate device. For AED algorithms, typical acceptance criteria would involve sensitivity (true positive rate for shockable rhythms) and specificity (true negative rate for non-shockable rhythms). While specific numerical acceptance criteria are not presented in this document for the current submission, for similar AED algorithms, these often fall within ranges like:

Study Proving Acceptance Criteria:
The document states: "No human clinical studies were submitted as part of this 510(k) Premarket Notification." Instead, the submission relies on "Performance Testing" including:

• Design Requirements Testing
• Hardware Verification
• Software Performance
• Electrical Safety and Electromagnetic Compatibility
• Design Validation via Animal Studies and Simulated Use Testing

The core claim is substantial equivalence to previously cleared LIFEPAK 15 monitor/defibrillators (K082937, K103567). The performance of the Shock Advisory System™ algorithm is explicitly stated as unchanged from the predicate device. Therefore, the "study" proving acceptance criteria for the algorithm's performance would have been conducted for the predicate devices, and the current submission relies on that prior clearance and the assertion that the algorithm itself has not changed.

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

Not provided in this document. Information on test set size and data provenance for the Shock Advisory System™ algorithm would have been part of the original 510(k) submission for the predicate devices. This document explicitly states: "No human clinical studies were submitted as part of this 510(k) Premarket Notification."

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 provided in this document. This information would be specific to the ground truth establishment for the predicate device's algorithm validation.

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

Not provided in this document. This information would be specific to the ground truth establishment for the predicate device's algorithm validation.

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 MRMC study was done or reported in this 510(k) submission. The Shock Advisory System™ algorithm in an AED is typically a standalone algorithm designed to automatically detect shockable rhythms, rather than an AI-assisted interpretation tool for human readers in the context of MRMC studies. The device is intended for use by trained medical personnel, including those using the "Automated External Defibrillation" mode, which implies the algorithm is acting as a decision-maker (shock/no shock) rather than an assistant to a human interpreter in the sense of a diagnostic imaging AI.

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

Yes, for the Shock Advisory System™ algorithm, its function in AED mode is inherently standalone in its determination of whether a rhythm is shockable or not. The document states: "Automated External Defibrillation: AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm." This "analysis" is performed by the algorithm. The performance of this standalone algorithm would have been assessed during the predicate device's clearance. This 510(k) asserts the algorithm is unchanged.

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

Not explicitly stated in this document. For AED algorithms, ground truth for rhythm classification (e.g., ventricular fibrillation, asystole, normal sinus rhythm) is typically established by:

• Expert Consensus on ECG Tracings: Review by cardiologists or emergency physicians.
• Simulated Rhythms: Using synthesized or recorded rhythm libraries with known classifications.
• Clinical Outcomes/Events: Correlation with actual patient response to therapy, though less direct for algorithm validation.

It's highly probable that expert consensus on ECG tracings was used for the predicate device.

8. The sample size for the training set

Not provided in this document. This information would be specific to the development and validation of the Shock Advisory System™ algorithm for the predicate devices. Modern AI/ML algorithms often have very large training sets; for the kind of algorithms in AEDs cleared in 2009/2011, training sets might have been smaller, focusing on diverse representations of specific arrhythmias.

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

Not provided in this document. Similar to question 7, ground truth for the training set (if applicable, as the algorithm might be rule-based rather than machine learning trained) would have been established by expert review of ECG tracings or use of labeled rhythm databases.

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To power the functions of various devices for which batteries or battery packs are configured.

Since non-rechargeable batteries and battery packs are "device specific" and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, or install these devices.

This battery is shipped only to customers who request a replacement battery for a PhysioControl LP500 AED (OEM P/N: 3005380-026, 11141-00013) or to replace a competitor's replacement battery for the same AED.

Biomedical equipment service professionals therefore know that the intended use is as a replacement battery.

Non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment. These devices provide a means of supplying electrical power through chemical reaction. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current used by the device into which they are installed. The performance and life span of these batteries depends on operating conditions of temperature, current drain, and the discharge method. These parameters are taken into account in designing such batteries. The goal is to develop battery packs that maintain capacity for as high and as long as possible under a specified range of environmental conditions.

This document is a 510(k) summary for a replacement battery pack, not a comparative effectiveness study or a standalone AI algorithm performance study. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design for proving equivalence, and information about AI model testing.

Here's a breakdown of what can be gleaned from the provided text, and what cannot:

What can be extracted (though not in the format requested as it's not a performance study):

• Device: R & D Battery Pack P/N 6019
• Intended Use: To power functions of various devices, specifically as a replacement battery for a PhysioControl LP500 AED.
• Predicate Device: AMCO Battery Pack P/N 5L500, also used in the PhysioControl LP500 AED.
• Basis of Equivalence: The document states "The design components and functionality of the R & D Batteries Inc. P/N 6019 battery pack is identical to the predicate device. Cell chemistry and type are identical. Sealed (Vented) Lithium / Sulphur Dioxide (Li/SO2)."

Information that is NOT available in this document:

Since this is a 510(k) premarket notification for a battery pack, not a medical device driven by an algorithm or intended for diagnostic/therapeutic functions requiring complex performance metrics, the following information is not applicable or not provided:

1. A table of acceptance criteria and the reported device performance: While there would be internal specifications and performance targets for the battery, this document does not present them as "acceptance criteria" for a primary efficacy or diagnostic study. The equivalence is based on being "identical" to a predicate, not necessarily meeting a specific set of clinical performance cutoffs.
2. Sample size used for the test set and the data provenance: Not applicable. Equivalence is primarily demonstrated through design and material identity, along with bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no ground truth in the context of expert consensus for a battery's performance in this type of submission.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a battery, not an algorithm.
7. The type of ground truth used: Not applicable in the context of clinical outcomes or expert consensus. For a battery, "ground truth" relates to its physical and electrical properties meeting specifications.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable.

What performance/safety testing was done (as per the document):

• Type of Study: Bench tests
• Equipment used: Medtronic's/PhysioControl LP500 AED and a NETECH Model Delta 2200 Defibrillator Analyzer.
• Tests conducted:
  • Life Cycle
  • Temperature
  • Mechanical & Electrical Component Integrity
• Reference: The document refers to "013 Performance Testing for procedures and results," which is an internal document not provided here.

In summary, this document is a regulatory submission demonstrating substantial equivalence of a replacement battery pack to an existing one, based on identical design, materials, and bench testing, rather than a clinical study evaluating diagnostic or therapeutic efficacy of a complex medical device or AI system.

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