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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 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 Propag 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, esophageal, 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 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 for use in acquiring, analyzing and reporting physiological data via 12lead 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 Propaq M Mobile Streaming Client Application is intended for use by trained medical personnel familiar with basic monitoring, vital sign assessment, and emergency cardiac care in order to remotely view near real-time patient and device data transmitted from connected Propaq M devices. It requires a clinician at the patient's side next to the Propaq M device. The information streamed to the client application helps the remote clinician make decisions on patient care supplemental to the clinician on site with the patient. Important: The remote clinician should not use Mobile Streaming as a primary diagnostic device, but instead use the data to consult with the clinician at the patient side.

The proposed Propaq 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 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.

With the current application, we propose a revision to the Propaq M device software to introduce Mobile Streaming Client (MSC) Software Application. The proposed MSC Application is a software application used in adjunct to the Propaq M device. It is intended for use by trained medical personnel familiar with basic monitoring, vital sign assessment, and emergency cardiac care in order to remotely view patient and device data transmitted from a connected Propaq M device.

Use of MSC requires a clinician at the patient's side next to the Propaq M device. The information streamed to the client application helps a remote clinician make decisions on patient care supplemental to the decisions made by the clinician on site with the patient. The MSC Application is a software application separate from the Propaq M device and its software. The remote clinician(s) utilize the client application from a desktop computer that allows them to remotely view the streamed data in real-time from active ZOLL Propag M devices in the field. MSC is a server-based application viewed through a web browser via the MSC Website.

The provided FDA 510(k) summary for the ZOLL Propaq M device (K180482) focuses on establishing substantial equivalence to a predicate device (ZOLL Propaq XM, K121367) for various monitoring capabilities and, specifically for this submission, the introduction of a Mobile Streaming Client (MSC) software application.

Based on the provided text, the document states: "Clinical evidence was not necessary to show substantial equivalence." This means that the submission does not contain clinical studies demonstrating the device meets specific performance acceptance criteria through patient data. Instead, non-clinical evidence was primarily used to establish substantial equivalence, particularly for the software modifications related to the Mobile Streaming Client.

Therefore, many of the requested details about acceptance criteria and studies (like sample size for test sets, expert ground truth, MRMC studies, standalone performance with metrics like sensitivity/specificity, and ground truth for training sets) are not present in this document because a clinical study of that nature was not conducted nor deemed necessary for this 510(k) submission.

However, I can extract information related to the non-clinical evidence provided.

Description of Acceptance Criteria and Device Performance (Based on Non-Clinical Evidence)

Since a clinical study with explicit acceptance criteria for diagnostic performance is not detailed, the "acceptance criteria" here refer to the successful completion of verification and validation activities and compliance with recognized standards for the software and device safety. The device performance is described in terms of meeting these engineering and regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. The document explicitly states, "Clinical evidence was not necessary to show substantial equivalence," so there isn't a "test set" in the context of clinical diagnostic performance. The testing mentioned (Software V&V, safety, usability) would involve various internal test cases and scenarios rather than a clinical patient data set.

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

• Not Applicable. No clinical ground truth was established by experts for a test set in this submission.

4. Adjudication Method for the Test Set

• Not Applicable. No clinical test set requiring expert adjudication was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study was not conducted or mentioned in this submission.

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

• Not Applicable. While the Mobile Streaming Client (MSC) is a software application, the submission does not provide specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be associated with an AI algorithm's diagnostic capability. The MSC's function is for remote viewing of data, not independent diagnosis, and the document emphasizes: "Important: The remote clinician should not use Mobile Streaming as a primary diagnostic device, but instead use the data to consult with the clinician at the patient side."

7. The Type of Ground Truth Used

• Engineering Specifications and Regulatory Standards. For the software verification and validation, the ground truth would be the predefined functional requirements and performance specifications of the device. For safety and EMC, the ground truth is compliance with the recognized international standards (e.g., IEC 60601 series, ISO 80601 series). For usability, the ground truth would be successful completion of defined usability tasks and mitigation of identified hazards.

8. The Sample Size for the Training Set

• Not Applicable. The submission does not describe an AI/machine learning model that would require a "training set" in the conventional sense for diagnostic performance.

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

• Not Applicable. As no training set for an AI/ML model for diagnostic performance is mentioned, the method for establishing its ground truth is not applicable to this document.

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

ECG Monitoring: The Propaq M is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction.

Non-Invasive Blood Pressure Monitoring: The Propag M is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg. The patient population will range from newborn (neonate) to adult.

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Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

This document is a 510(k) clearance letter for the Zoll Propaq M Monitor. It approves the marketing of the device based on its substantial equivalence to previously marketed devices. It does not contain information about a study conducted to prove the device meets specific acceptance criteria in the manner typically described for AI/ML device evaluations.

The information provided describes the intended use and indications for use for various monitoring functions, and mentions patient populations. However, it does not include data from a performance study comparing the device's output to defined acceptance criteria. This type of regulatory submission (510(k) premarket notification) for a cardiac monitor typically relies on verification and validation testing demonstrating the device meets its own specifications, rather than a large-scale clinical study for performance metrics like sensitivity and specificity against a ground truth as would be seen for an AI/ML diagnostic or screening tool.

Therefore, many of the requested fields cannot be filled from the provided text because the document does not describe the kind of study implied by the prompt.

Here's what can be extracted and what cannot:

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

• Cannot provide this from the text. The document describes the device's intended functions (ECG monitoring, non-invasive blood pressure monitoring, heart rate alarming) and its patient populations (newborn to adult). It does not present specific performance metrics (e.g., accuracy, sensitivity, specificity, or precision) against numerical acceptance criteria.

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

• Cannot provide this from the text. The document does not describe a clinical test set or its sample size.

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)

• Cannot provide this from the text. The document does not describe the establishment of ground truth by experts for a test set.

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

• Cannot provide this from the text. The document does not describe a test set or its adjudication.

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 such study was done. This device is a cardiac monitor, not an AI-assisted diagnostic tool. The document describes a medical device for vital sign monitoring, not a system that assists human readers in interpreting images or data. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

• Not applicable as described for AI/ML. The Propaq M is a physical medical device (monitor) that performs measurements and displays data. While it contains algorithms for signal processing and parameter calculation, the concept of "standalone algorithm" performance in the context of AI/ML is not directly relevant here in the way it would be for a diagnostic algorithm. The device itself is "standalone" in its function as a monitor, but the document does not detail validation of its internal algorithms in isolation from the hardware.

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

• Cannot provide this from the text in the context of a performance study. For a cardiac monitor, "ground truth" would typically relate to the accuracy of the physical sensors and internal signal processing against known standards or reference devices (e.g., an ECG simulator, a calibrated pressure transducer). However, the document does not detail these technical performance tests or the "ground truth" used for them.

8. The sample size for the training set

• Cannot provide this from the text. This device is a traditional medical monitor, not an AI/ML device that requires a "training set."

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

• Cannot provide this from the text. This device is a traditional medical monitor, not an AI/ML device that requires a "training set."

Summary of what the document does provide:

• Device Name: Zoll Propaq M Monitor
• Regulatory Class: Class II
• Product Codes: DRT, DXN, DSK, CCK, DQA
• Intended Users: Trained medical personnel, physicians at emergency scenes or in hospital settings (emergency room, ICU, CCU, etc.).
• Usage Environments: Ambulance, emergency scene, patient transport, hospital.
• Patient Populations: Newborn (neonate, birth-1 month), Infant (1 month-2 years), Child (2-12 years), Adolescent (12-21 years), and Adult (21 years or older). Used on patients with and without heart dysfunction.
• Specific Functions (Indications for Use):
  • ECG Monitoring: Monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate; alarm for heart rate outside operator-set limits.
  • Non-Invasive Blood Pressure Monitoring: Make non-invasive measurements of arterial pressure and heart rate using an inflatable cuff; alarm if either parameter is outside user-set limits.

This document serves as a regulatory clearance for a traditional medical device based on substantial equivalence, not a detailed performance study report for an AI/ML diagnostic or screening algorithm against specific clinical acceptance criteria.

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