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Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an "MRI conditional" label, ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL ventilatiors are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers.

The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 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 ZOLL 731 Series Ventilators family consists of AEV, EMV+, Eagle II and Z Vent models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (≥ 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV) Positive Pressure Ventilation (PPV).

The provided document is a 510(k) premarket notification letter and summary for the ZOLL 731 Series Ventilator. It details the device, its intended use, and the comparisons made to a predicate device to establish substantial equivalence.

However, the request asks for information about acceptance criteria and a study that proves a device meets those criteria, specifically in the context of an AI/algorithm-driven medical device. The document provided does not describe an AI/algorithm-driven device. Instead, it is for a ventilator (a mechanical device with updated software), and the "study" referred to is primarily non-clinical evidence (software verification and validation testing, safety testing per international standards, electrical safety, EMC, and usability testing with no changes to the UI). There is no mention of an algorithm or AI that generates outputs requiring ground truth, expert adjudication, or MRMC studies for evaluation.

Therefore, I cannot fulfill the request with the provided input because the input document does not contain the necessary information about acceptance criteria and studies for an AI/algorithm-driven device.

The document explicitly states:

• "Clinical evidence was not necessary to show substantial equivalence."
• The primary change is a "software revision 5.25, which updates the ventilator alarm logic." This is a rule-based or programmatic change, not an AI/ML model.
• The comparison is based on "Alarm System, Functions and Features, Indications for Use, Intended Use, Labeling, Pulse Oximeter Specifications, Ventilator Specifications." These are typical for traditional medical device updates, not AI.

If the request refers to general device acceptance criteria and testing (not specific to AI/algorithms), then the relevant parts of the document are the "Substantial Equivalence - Non-Clinical Evidence" section, which details the various tests and standards met:

• Software Verification and Validation Testing: This is the primary "study" proving the device meets its software-related acceptance criteria. The document states this testing "ensured that the 731 Series Ventilators performs as well as the indicated predicate devices and met all its functional requirements and performance specifications."
• Safety Testing per International Standards: Compliance with a long list of international standards (IEC 60601-x, ISO 15223-1, EN 1789, etc.) serves as the acceptance criteria for safety and effectiveness in various aspects. The "Table 1: 731 Series Ventilator Compliance Standards" lists these.
• Usability Testing: The document states "No usability validation is included in this plan. The user interface remains unchanged." This implies that the acceptance criterion for usability was "no change from predicate" and thus no new testing was needed.
• Electrical Safety and Electromagnetic Compatibility (EMC): Tested to meet applicable standards listed in Table 1.

However, the request is very specific about AI-related evaluation elements (MRMC, standalone algorithm, ground truth methods, training set, etc.), which are entirely absent from the provided document.

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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 Power Infuser® is intended for continuous or intermittent administration of therapeutic and clinically appropriate intravenous fluids, blood and packed red blood cells through clinically acceptable access points. The device is intended for use by medical and EMT personnel in the field and in pre-hospital and hospital environments.

When used with the Crystalloid Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood or blood products.

When used with the Blood Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids, whole blood and packed red blood.

The device is not intended to support the delivery of any pharmaceutical or other medications.

The ZOLL Power Infuser (reviewed and cleared with K090736) is a miniature battery-operated infusion pump designed for rapid intravenous fluid delivery in the field, in pre-hospital transport, or in the hospital. The device supports two types of Power Infuser Cartridges, both of which are sterile and intended for single use:

• · When used with the Crystalloid/Colloid Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood or blood products.
• · When used with the Blood Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. whole blood and packed red blood cells.

The device, along with the cartridges, is not intended to support the delivery of any pharmaceutical or other medications.

Power infuser works on the principle of the shuttle pump mechanism wherein the tubing in the cartridges is squeezed (but not fully occluded) to allow the free flow of the fluid in the forward direction.

As a part of the current application we are proposing a material change to the tubing used in the Crystalloid/Colloid Cartridge and Blood Cartridge. The cleared DEHP Tygon tubing (S-40-HL Manufactured by Saint Gobain) has reached its end of life and we are proposing to replace it with the non-DEHP Tygon tubing (ND 100-40, manufactured by Saint Gobain).

The proposed material change is restricted to the Crystalloid/Colloid Cartridge and Blood Cartridge only. No changes has been made to the Power Infuser Pump as a result of the proposed change. The indications for use of the device, as described in the current application, has not changed as a result of the proposed modification.

No new accessories have been added, as part of the current submission, due to the proposed change. All the accessories offered with the ZOLL Power Infuser have been reviewed and cleared with the K090736.

This document is a 510(k) premarket notification for a material change to the ZOLL Power Infuser, not a study evaluating acceptance criteria of a novel AI-based medical device. Therefore, the information requested in the prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable to this document.

The document describes a material change in the tubing of an existing infusion pump and provides non-clinical evidence (functional and biocompatibility testing) to demonstrate that the modified device remains substantially equivalent to its predicate.

However, based on the information provided in the document, here's what can be extracted regarding the device's testing and compliance, rephrased to align with the prompt's structure where possible, even if it doesn't directly answer all AI-focused questions:

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

Since this is not a study presenting specific quantitative acceptance criteria and performance metrics for a novel device, the table below reflects what was tested and confirmed for the material change. Specific numerical acceptance criteria are not detailed in this summary.

• ISO 10993-5 Test for In Vitro Cytotoxicity
• ISO 10993-10 Test for Irritation and Skin Sensitization
• ASTM F 756-13 In Vitro Hemolytic Properties of Materials
• ISO 10993-11 Test for Acute Systemic Toxicity and Pyrogenicity Test
• ISO 10993-4 Selection of tests for interactions with blood (Complement Activation test, In-vitro Hemocompatibility test, and Partial Thromboplastin test).
  The results of the Tygon Tubing Qualification and supplemental testing provide evidence that the cartridges with the new Tygon tubing meet the integrity and performance testing requirements. |
  | Substantial Equivalence | Proven by demonstrating that the proposed Power Infuser, with the new tubing, maintains the same intended use, operating mechanism, and function as the predicate device (K090736), and meets safety and performance standards equivalent to or better than the predicate. |

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

• Sample Size: Not specified in the provided text. The document mentions "validation testing" and "further tested," implying a defined test set, but the number of units or test runs is not disclosed.
• Data Provenance: Not specified. The testing was conducted to support a U.S. FDA 510(k) submission, so it would likely follow U.S. regulatory guidelines. The nature of the tests (functional, biocompatibility) suggests laboratory-based testing rather than clinical data from a specific country or retrospective/prospective clinical study.

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

• This is not applicable as the submission pertains to a material change in an infusion pump, which does not involve "ground truth" derived from expert interpretation in the same way an AI diagnostic device would. Functional and biocompatibility testing results are objective measurements against established standards, not expert consensus on interpretations.

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

• Not applicable. Adjudication methods are typically used in clinical studies or expert review processes for subjective assessments, which is not the nature of the validation testing described here.

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

• Not applicable. This device is an infusion pump, not an AI-assisted diagnostic tool involving human readers.

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

• Not applicable. This device does not have an AI algorithm.

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

• Not applicable in the context of an AI device. For this submission, the "ground truth" for material properties and device function would be established by scientific and engineering standards (e.g., material safety standards, flow rate accuracy standards, alarm activation thresholds) as measured through laboratory testing.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a training set.

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

• Not applicable. This device does not involve machine learning or a training set.

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Ventilation

Each model of the ZOLL 731 Series of Ventilators is in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an " label, ZOLL Ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL Ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers

Pulse Oximetry (SpO2)

The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse SpO2 oximeter and accessories are indicated for use on adult and pediatric patients during both no motion conditions, and for patients who are well or poorly perfused, in hospital-type facilities, or in mobile environments.

The ZOLL 731 Series Ventilators family (acquired by ZOLL Medical Corporation through an asset acquisition of Impact Instrumentation, Inc. and reviewed and cleared under K111473) consists of AEV, EMV+ and Eagle II models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (> 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV)/ Positive Pressure Ventilation (PPV).

As part of the current submission we are proposing to revise the device software to accomplish the following:

• Introduce Bilevel Mode Functionality
• Expanded Leak Compensation Functionality
• Introduce Start Menu Functionality
• . Expanded Parameter Ranges
• . Introduce Plateau Pressure (Pplat) Functionality
• . Introduce Automatic Tubing Compensation Functionality
• Change Oxygen Supply Pressure Alarm Logic
• Introduce Inverse I:E Ratio Functionality ●

No hardware changes were made to the 731 Series Ventilators for the proposed software change.

The provided text describes a 510(k) premarket notification for the ZOLL 731 Series Ventilators, focusing on software changes that introduce new functionalities. The document primarily focuses on non-clinical evidence to establish substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a specific table of "acceptance criteria" with numerical targets and corresponding "reported device performance" values in the traditional sense of a clinical or analytical performance study. Instead, the acceptance criteria are implicitly tied to the successful completion of various engineering and software validation tests, and compliance with recognized standards.

The document states:
"Extensive performance testing in the software verification and system level validation ensured that the 731 Series Ventilators performs as well as the indicated predicate devices and met all of its functional requirements and performance specifications."
and
"The device was evaluated and found to be in compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, EN 794-3, IEC 60601-1-8 and ISO 80601-2-61."

Therefore, the reported device performance is that these tests were passed and compliance was achieved, demonstrating that the device meets its design, performance, and safety specifications and is substantially equivalent to predicate devices.

Example Interpretation of Acceptance Criteria and Performance (as implied by the document):

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

The document does not specify a "test set" in the context of clinical data for performance evaluation. All testing mentioned is non-clinical (software verification/validation, safety testing, usability testing). Therefore, details like sample size for a test set (e.g., number of patients), country of origin, or whether it was retrospective/prospective are not applicable or provided.

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

This information is not provided. Since no clinical "test set" requiring ground truth establishment by experts is described, this detail is not relevant to the presented evidence.

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

This information is not provided because no clinical "test set" or expert adjudication process is described in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was conducted or reported. The device is a ventilator with software updates, not an AI-assisted diagnostic tool for human readers.

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

The device is a medical device (ventilator) with software as an integral component, not a standalone algorithm in the typical sense applied to AI/ML devices. The performance evaluation focuses on the integrated system (ventilator with new software). The software's performance was validated as part of the overall device performance through non-clinical testing.

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

Not applicable for the non-clinical testing described. For software verification and validation, the "ground truth" would be the pre-defined functional and performance specifications, and for safety, it would be compliance with published standards.

8. The sample size for the training set:

Not applicable. The document describes software updates to a medical device, not a machine learning or AI algorithm that requires a "training set" of data.

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

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

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The ZOLL® Model 330 Multifunction Aspirator is a self-contained suction device designed for removing debris from a patient's airway or respiratory system, secretions, blood, vomitus, tissue (including bone), bodily fluids and infectious materials during surgery. Programmable intermittent gastrointestinal and abdominal wound drainage can also be performed with the device. It is suitable for use in pre-hospital, mass casualty and transport environments, including aeromedical. The Model 330 is only for use by or on the order of a physician.

The ZOLL Model 330 Multifunction Aspirator is a product based on the currently marketed Model 326/326M Aspirator (acquired by ZOLL Medical Corporation through an asset acquisition of Impact Instrumentation, Inc., reviewed and cleared under K951423). Similar to the currently marketed 326 Aspirator, the ZOLL 330 Aspirator is a small, durable, full-featured portable aspirator designed to operate in the hospital, prehospital, field hospital, mass casualty and during ground or air transport settings.

Like the predicate 326 Aspirator, the proposed 330 Aspirator is an electrically powered suction pump intended to remove debris from a patient's airway or respiratory system, secretions, blood, yomitus, surgical fluids, tissue (including bone), bodily fluids and infectious materials during surgery. Both the devices can also be used to perform programmable intermittent gastrointestinal and abdominal wound drainage.

Both Aspirators can be operated from an AC or DC external power source, or from an internal rechargeable battery system, and supports both aspiration modes: Continuous and Intermittent. The Continuous mode in the proposed 330 Aspirator is sub-divided into four procedure types: Surgical, Pharyngeal, Tracheal, and CASS (Continuous Aspiration of Subglottic Secretions). Each procedure has a pre-set pressure range under which the device can be operated. Additionally with the proposed device we have introduced the following functionality:

• . Start Menu Functionality: Start Menu functionality is developed that allows the user to select from a series of preconfigured options that are appropriate for different patient groups: adult, pediatric, the last device settings and a custom start configuration established by the user or their organization.
• SMART FLOW Functionality: The feature detects a drop in the measured vacuum level when the ● therapy is not being applied and in response allows the aspirator to reduce the applied vacuum thereby allowing quieter operation of the device in the continuous mode.
• . ALARMS: The 330 Aspirator offers a suite of visual alarm indicators by illuminating red, yellow and green LED lights, and audible alarm indicators, to alert the user about issues relating to external power or battery, environmental conditions that could affect device performance, and device selfcheck failures.

The provided document describes a 510(k) premarket notification for the ZOLL Model 330 Multifunction Aspirator. This device is a powered suction pump and the submission focuses on demonstrating its substantial equivalence to a predicate device (Model 326/326M Aspirator).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

Key Takeaway: This submission primarily relies on non-clinical performance testing to demonstrate substantial equivalence, rather than clinical studies or extensive statistical evaluations of diagnostic performance. The device is a physical medical device, not an AI or imaging diagnostic tool, so the typical AI/ML-specific criteria requested in the prompt (like multi-reader studies, ground truth for training data, etc.) are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantified, pass/fail manner for the device's overall performance. Instead, it demonstrates compliance with recognized standards and verifies specific performance parameters through testing. The "reported device performance" is largely described by meeting these standards and verifying functional requirements.

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

• Test Set Sample Size: Not explicitly stated in terms of a "test set" for performance evaluation, as this is not a diagnostic device involving patient data samples. The testing described (software V&V, safety, EMC, usability) refers to engineering and functional tests on the device hardware and software. There is no information about a "test set" in the context of patient data.
• Data Provenance: Not applicable. The "data" here refers to test results from engineering and functional evaluations of the device, not patient data.

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

• Number of Experts & Qualifications: Not applicable. Ground truth, in the context of diagnostic AI/ML, refers to a definitive diagnosis or outcome. For a physical medical device like an aspirator, "ground truth" is established by engineering specifications, safety standards, and functional requirements. Expert review likely occurred in the design, testing, and regulatory submission process by engineers and regulatory specialists, but not in the sense of physicians establishing ground truth for a diagnostic test.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No "test set" of cases requiring adjudication for diagnostic accuracy is present.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This is not an AI/ML diagnostic device, so a MRMC study is not relevant.

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

• Standalone Performance: Not applicable. This is a physical aspirator device, not an algorithm. Its performance is inherent to its mechanical and electrical function.

7. The Type of Ground Truth Used

• Type of Ground Truth: For a physical medical device like the Model 330 Multifunction Aspirator, the "ground truth" for demonstrating performance and safety is derived from:
  • Engineering Specifications: The device must perform according to its design specifications (e.g., free flow rate, suction pressure range).
  • International Consensus Standards: Compliance with established safety (e.g., IEC 60601-1) and performance (e.g., ISO 10079-1 for suction equipment) standards serves as the ground truth for safety and baseline functionality.
  • Predicate Device Performance: The device's ability to operate with similar, or improved, functional characteristics compared to its legally marketed predicate device (Model 326/326M Aspirator) is a key "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not employ machine learning or AI that requires a "training set" of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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

Manual Defibrillation: Use of the X Series in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

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

ECG Monitoring: The X Series is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients.

External Transcutaneous Pacing: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology; As a standby when standstill or bradycardia might be expected; Suppression of tachycardia; Pediatric pacing.

Non-Invasive Blood Pressure Monitoring: The X Series is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg.

Temperature Monitoring: The X Series is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.

SpO2 Monitoring: The X Series pulse CO-oximeter with Masimo Rainbow SET technology is intended for use for continuous noninvasive monitoring 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).

Respiration Monitoring: The X Series is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor.

CO2 Monitoring: The X Series is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath rate.

Invasive Pressure Monitoring: The X Series is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply.

12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data.

Web Console: X Series Web Console functionality allows medical personnel to view physiological data available on a connected X Series device. Physiological data may include ECG, noninvasive blood pressure, SpO2/SpCO/SpMet, end-tidal carbon dioxide, respiration rate, invasive blood pressure, temperature, and Heart Rate.

The X Series (reviewed and cleared under K133269 and K133484) is a lightweight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitors (including ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and respiration monitoring). The currently marketed ZOLL X Series device (K133269 and K133484) uses the Masimo Rainbow SET technology to offer the SpO2, SpCO and SpMet functionality. With the current application, we are proposing to revise the X Series software to optionally support additional monitoring parameters - Total Hemoglobin (SpHB), Oxygen Content (SpOC), Pleth Variability Index (PVI) and Perfusion Index (PI), offered by the Masimo Rainbow SET Technology board that is installed in the currently marketed X Series device (K133269 and K133484).

The provided text describes ZOLL X Series device and its substantial equivalence to predicate devices, particularly concerning new monitoring parameters. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the ZOLL X Series (K142915) is an update to an existing device (K133269 and K133484) to include additional monitoring parameters: Total Hemoglobin (SpHB), Oxygen Content (SpOC), Pleth Variability Index (PVI), and Perfusion Index (PI). These parameters are enabled by the Masimo Rainbow SET Technology board, which was already installed in the device, through new software and licenses.

The key acceptance criterion is demonstrating substantial equivalence to the predicate device, the Masimo Radical 7 Pulse CO-Oximeter and Accessories (K110028), for these new monitoring parameters. The reported performance is that the ZOLL X Series, utilizing the same Masimo Rainbow SET Technology, has the same performance specifications as the predicate device for SpHB, SpOC, PVI, and PI.

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

The document does not specify a separate "test set" for the new parameters in the context of a prospective clinical study directly for K142915. Instead, it relies on the performance of the Masimo Rainbow SET Technology, which was already established in the predicate device (K110028).

• Sample Size for Test Set: Not applicable/not explicitly stated for K142915. The evaluation for the new parameters leverages the performance data from the predicate device (Masimo K110028).
• Data Provenance: The performance of the Masimo Rainbow SET Technology board and its software for these parameters was "established and subsequently cleared by the agency under K110028." This implies the original data for K110028 would have included clinical or performance data for these specific parameters. The provenance of that original data (country, retrospective/prospective) is not detailed in this document.

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

Not applicable. The substantial equivalence argument for the new monitoring parameters within K142915 hinges on the fact that the underlying technology and software for these parameters were already cleared under K110028 (Masimo Radical 7 Pulse CO-Oximeter). There is no mention of a new expert panel or ground truth establishment specifically for the K142915 submission regarding these parameters.

4. Adjudication method for the test set

Not applicable. As noted above, the submission relies on previously cleared technology and software.

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

Not applicable. This device is a medical monitoring and defibrillation system, not an AI-assisted diagnostic imaging or interpretation tool that would typically involve human readers.

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

The performance of the algorithm (Masimo Rainbow SET Technology software) for the additional parameters (SpHB, SpOC, PVI, PI) was established as part of the clearance for the predicate device, Masimo Radical 7 Pulse CO-Oximeter (K110028). The current submission states that the ZOLL X Series incorporates this same "relevant license and the software code" whose "performance of which was established under K110028." This implies a standalone evaluation of the algorithm's performance for these parameters occurred within K110028.

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

The document does not explicitly state the type of ground truth used for the original Masimo K110028 clearance related to SpHB, SpOC, PVI, and PI. For physiological monitoring parameters like these, ground truth typically involves a reference standard measurement method (e.g., laboratory blood analysis for hemoglobin, or invasive continuous measurement for pressure/perfusion indices).

8. The sample size for the training set

The document does not provide information about a "training set" for the software in K142915. The evaluation relies on the already established performance of the Masimo Rainbow SET Technology from K110028. If machine learning was involved in the development of the Masimo algorithm, such information would have been part of the K110028 submission, but it's not referenced here for K142915.

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

Not applicable, as no training set information is provided in this document for the K142915 submission.

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

The predicate X Series is a lightweight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitors (including ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and respiration monitoring).

With the current application, we are proposing to revise the X Series communication processor software to create a web page with a graphical trend format and countdown timer for ventilations that consolidates the existing SBP (systolic blood pressure from the NIBP monitoring), SpO2, EtCO2 data and the timer on the display of the X Series. The access to this web page will be marketed as the Traumatic Brain Injury (TBI) Dashboard. This TBI Dashboard assists the operator who is ventilating a patient to follow recommendations in the TBI guidelines. Through an encrypted and password protected communications protocol, a suitable separate device with touchscreen, web browser capability and Bluetooth communications can display the TBI Dashboard.

As described above, the proposed software change impacts only the communication aspects of the X Series device. Therapeutic and monitoring capabilities of the X Series device as cleared under K133269 have remained unchanged and are not impacted by the proposed change. The X Series therapeutic and monitoring functionality is entirely controlled by access directly through the X Series device, itself, and not through the TBI Dashboard. TBI Dashboard is intended to supplement and not replace any part of the device monitoring.

The provided text describes the ZOLL X Series, a multi-function medical device that includes capabilities such as defibrillation, ECG monitoring, CPR monitoring, pacing, and various physiological monitoring functions (NIBP, temperature, SpO2, respiration, CO2, invasive pressure). The 510(k) submission (K141774) is specifically for a revision to the X Series communication processor software to add a "TBI Dashboard" functionality.

However, the document does not explicitly state specific acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy, error rates) for the device's various functions, nor does it provide detailed descriptions of studies proving these criteria are met. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.

The "Performance Testing" section states: "Extensive performance testing in the form of the software verification and system level validation ensures that the ZOLL X Series performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards." This is a general statement about the type of testing performed, not a detailed report of the results against specific criteria.

The 510(k) summary focuses on the TBI Dashboard functionality, which is a software revision. For this new feature, the document asserts substantial equivalence to two predicate devices:

• ZOLL RescueNet Link (K111296) for collecting and displaying data in a web page format.
• L770-CPR Resuscitation Timer (K062080) for ventilation rate timer functionality.

Given this, I will infer what the "acceptance criteria" likely are based on the substantial equivalence claims and the general nature of medical device clearances. The "reported device performance" will be based on the general statements made about meeting requirements.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide details on specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) for the software verification and system-level validation. The nature of the submission (a software update for a display feature) suggests that these tests would primarily involve engineering and software validation rather than clinical data from a "test set" in the traditional sense of patient data. For the original X Series functions, such data would have been part of the K133269 submission, but not detailed here.

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

Not applicable/provided. The submission relies on demonstrating substantial equivalence to predicate devices and general software verification/system validation, rather than a clinical study requiring expert-established ground truth for a novel diagnostic or treatment outcome.

4. Adjudication method for the test set

Not applicable/provided for the reasons stated above.

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 or reported. This submission is for a device update adding a dashboard, not a novel diagnostic AI algorithm. The TBI Dashboard is described as a "supplement and not replace any part of the device monitoring," and the ventilation timer as a "visual aid," implying it supports human users rather than being an AI system that improves human "reading" performance in a diagnostic context.

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

This is not applicable. The device is a patient monitor/defibrillator with software features, not a standalone algorithm. The TBI Dashboard is a display feature for existing data.

7. The type of ground truth used

For the software revision adding the TBI Dashboard, the "ground truth" would likely be the correct functioning of the software according to its design specifications, accuracy in displaying data from the device sensors, and adherence to accepted communication protocols for web page display. This would be established through software unit testing, integration testing, and system validation against known correct values or predicate device behavior. No external expert consensus, pathology, or outcomes data is mentioned for this particular update.

8. The sample size for the training set

Not applicable. The X Series and its TBI Dashboard are not described as machine learning or AI-based systems that require a "training set" for model development.

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

Not applicable for the reasons stated above.

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Defibrillator Function: The E Series ALS 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 ALS products must be prescribed for use by a physician or medical advisor of an emergency response team.

Intended Use — Manual Operation: Use of the E Series ALS 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 ALS 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.

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

Intended Use - Pacemaker: 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 bradvcardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia.

Pediatric Pacing: Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.

Monitor Intended-Use Multi-parameter Monitoring: 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 predicate ZOLL E Series External Defibrillator/Monitor reviewed and cleared by the FDA (K111594 and K092598) is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. It combines the function of a manual defibrillator, noninvasive transcutaneous pacer. ECG monitor, pulse oximeter, end tidal CO2 monitor. 12-Lead EGG monitor, non-invasive blood pressure monitor and CPR performance monitor along with data printing and recording capabilities. Functions are offered as options, and functions can be configured during manufacturing to meet the needs of a particular application. Through a manufacturing configuration option that is already available in the device's software and currently offered for distribution (reviewed and cleared by FDA under K111594), the ECG rhythm analysis (advisory) option can be disabled during the manufacturing of the device. This creates a manual-only/ non-AED configuration of the device which is marketed as E Series ALS and intended to be used by ACLS qualified personnel. On the hardware side, the front panel that is offered with this configuration does not include the analyze button that is used to initiate ECG rhythm analysis.

This document is a 510(k) premarket notification for the "Zoll E Series ALS" device. The manufacturer is seeking clearance for a specific configuration of an existing device (Zoll E Series cleared under K111594 and K092598) as a standalone Class II device. The key aspect is that this new configuration, E Series ALS, disables the ECG rhythm analysis (advisory) option and removes the "analyze" button, making it a manual-only/non-AED configuration.

Based on the provided text, there are no specific acceptance criteria or a dedicated study described to demonstrate the device meets acceptance criteria as typically found for new device functionality or performance claims. The fundamental argument for clearance in this submission is that no new device functionality or performance is being introduced.

Here's an analysis based on the structure of your request:

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

   • Acceptance Criteria: Not explicitly stated as new criteria. The device is leveraging the performance and safety established for its predicate device (Zoll E Series, K111594 and K092598). The central "acceptance" is that the removal of the AED/advisory functionality does not introduce new risks or modify existing performance.
   • Reported Device Performance: No new performance metrics are reported in this particular submission. The device's performance characteristics (defibrillation energy delivery, pacing, monitoring vital signs, CPR feedback) are presumed to be the same as the cleared predicate device.

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

   • No new test set was used for this submission. The submission explicitly states: "No new product or software requirements were introduced... and therefore, no additional design or software verification or validation testing was necessary." This implies reliance on the testing performed for the predicate device.

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

   • Not applicable. No new test set requiring expert ground truth establishment for novel functionality was used in this submission.

4. Adjudication method for the test set

   • Not applicable. No new test set.

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

   • Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study was conducted or referenced in this document.

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

   • Not applicable. This device is a medical device with various monitoring and therapeutic functions, not an algorithm. The 510(k) submission itself is for a "standalone Class II clearance" in the regulatory sense, but not for a standalone algorithm performance study. In fact, the removal of an "algorithm-like" function (ECG rhythm analysis/advisory) is a key aspect of this submission.

7. The type of ground truth used

   • Not applicable for this submission. For the predicate device, the ground truth would have been established through a combination of engineering testing, clinical studies, and compliance with performance standards typical for defibrillators, pacemakers, and patient monitors.

8. The sample size for the training set

   • Not applicable. This submission does not involve a machine learning algorithm or a specific training set.

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

   • Not applicable.

Summary of the document's argument regarding acceptance criteria and testing:

The core of this 510(k) submission for the Zoll E Series ALS is that it is a configuration of an already cleared device (Zoll E Series, K111594). The key modification is the disabling of the ECG rhythm analysis (advisory) option and the removal of the "analyze" button, effectively creating a manual-only defibrillator for use by ACLS qualified personnel.

The manufacturer explicitly states:

• "No software modifications were needed to produce the E Series ALS..."
• "The capability to configure the device as E Series ALS during the manufacturing process by disabling the ECG rhythm analysis already existed in the predicate device cleared under K111594."
• "No new product or software requirements were introduced... and therefore, no additional design or software verification or validation testing was necessary."
• "Removal of the 'Analyze' button from the front panel... did not introduce any new risks, or raise any usability issues or concerns..."

Therefore, the "acceptance criteria" discussed in this document are implicitly the safety and effectiveness criteria established and met by the predicate device (K111594/K092598). The "study that proves the device meets the acceptance criteria" is essentially the original testing and clearance data for the predicate device, combined with the argument that removing a feature does not negatively impact the device's substantial equivalence or safety profile. The FDA's issuance of the clearance letter (Pages 0-1) indicates their agreement with this assessment for regulatory purposes.

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