Search Results

Panel

Reference & Predicate Devices

K121367

Predicate For

K202375

Intended Use

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 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 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 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.

Device Description

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.

AI/ML Overview

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

Feature/Study/Standard	Acceptance Criteria (Implied)	Reported Device Performance
Software V&V	Meets functional requirements and performance specifications, commensurate with a "major" level of concern for safety.	"Extensive performance testing in the form of the software verification and system level validation ensured that the Propaq M performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications."
Safety Testing	Compliance with applicable sections of recognized industry and safety standards.	"The device was evaluated and found to be in compliance with IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-25, ISO 80601-2-61 and other applicable particular standards."
Electrical Safety & EMC	Proposed software-only change does not impact EMC and Electrical Safety.	"The Electromagnetic Compatibility and Electrical Safety aspect of the Propaq M device has not been impacted by the proposed change."
Usability Testing	Appropriate usability activities conducted, including assessment of primary operating functions, intended users, use scenarios, and corresponding use-related hazards.	"Usability evaluation was conducted to determine the appropriate usability activities for the Propaq M Mobile Streaming Client Application. As part of this process the primary operating functions, intended users and use scenarios and corresponding use related hazards were assessed."

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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K Number

K112761

Device Name

ZOLL PROPAQ MD

Manufacturer

Date Cleared

2012-04-25

(216 days)

Product Code

MKJ,CCK,DQA,DRO,DRT,DSK,DXN,LDD,LIX

Regulation Number

870.5310

Type

Panel

Reference & Predicate Devices

K100654,K072923,K032145

Predicate For

N/A

Intended Use

The Propaq MD 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 Propaq MD. The Propaq MD is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq MD 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 Propaq MD 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 Propaq MD 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): The Propaq MD 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 Propaq MD 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 Propaq MD is intended for use to monitor and/or record 3, 5, 12-Lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

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.

Non-Invasive Blood Pressure Monitoring: The Propaq MD 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.

Temperature Monitoring: The Propaq MD 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 Propaq MD is intended for use to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user.

Respiration Monitoring: The Propaq MD is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. It is not intended to be used as an apnea monitor.

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

Invasive Pressure Monitoring: The Propaq MD 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.

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.

Device Description

The ZOLL Propaq MD device (reviewed and cleared by the agency under application K100654) is being revised with additional software features. The Propaq MD is a light weight, portable device designed to be used by trained medical personnel who are familiar with basic monitoring, vital sign assessment and emergency cardiac care. As in its previous configuration, the Propaq MD combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, non-invasive blood pressure monitor, invasive pressure monitor, respiration rate monitor and temperature monitor. Functions are offered as options and functions can be configured to meet the needs of a particular application. Additionally, the proposed configuration adds the following features: Semi-automatic external defibrillation function (AED) Mode, Inovise Audicor 12-Lead ECG Interpretive Algorithm, ECG Life Threatening Alarms, Expanded Data Logging capabilities.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study information for the ZOLL Propaq MD, based on the provided text:

Important Note: The provided 510(k) summary (K112761) from 2012 focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results for the newly added features like the Inovise Audicor 12-Lead ECG Interpretive Algorithm. FDA 510(k) submissions for substantial equivalence often refer to the predicate device's performance for new features, or use a general statement about performance and safety testing. Therefore, the information directly addressing specific quantitative acceptance criteria and detailed study designs for the new features is limited in this document.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for substantial equivalence, specific quantitative acceptance criteria for the newly added features (e.g., specific sensitivity/specificity for the 12-Lead ECG Interpretation) are not explicitly stated in this document. Instead, the "acceptance criteria" are generally implied to be that the device performs as well as the predicate devices and meets its functional requirements and performance specifications.

The document claims:

"Extensive performance testing ensures that the proposed ZOLL Propaq MD 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."

For the purpose of this analysis, I will infer the performance for the Inovise Audicor 12-Lead ECG Interpretive Algorithm feature by noting that the algorithm itself was a previously cleared device (K032145). In a typical 510(k) for an integrated component, the performance of the integrated component would usually be established in its own prior submission or validated against its established performance. The current K112761 document doesn't re-detail the specific performance of that algorithm in this submission.

Feature / Metric	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
General Device Performance	Performs as well as predicate devices and meets functional requirements and performance specifications. Compliance with safety standards.	"Extensive performance testing ensures that the proposed ZOLL Propaq MD 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."
Inovise Audicor 12-Lead ECG Interpretive Algorithm	Substantially equivalent to the performance demonstrated in K032145.	Integrated the previously cleared Inovise Audicor 12-Lead Interpretive algorithm (K032145), implying its prior demonstrated performance is maintained.
AED Mode Performance (Semi-automatic)	Substantially equivalent to the performance of predicate devices (ZOLL Propaq MD K100654, ZOLL E Series K072923) in delivering defibrillation in a semi-automatic manner.	Functions as an AED, requiring operator control for shock delivery, consistent with previously cleared devices.
ECG Life Threatening Alarms	Functional and reliable alarming as per industry standards and predicate devices.	Added as a feature; implicitly meets functional specifications.
Expanded Data Logging capabilities	Functional and reliable data logging.	Added as a feature; implicitly meets functional specifications.

Study Details for K112761:

Sample size used for the test set and the data provenance:
- The document does not specify a separate "test set" for the newly added features of the ZOLL Propaq MD (K112761). The focus is on demonstrating substantial equivalence to predicate devices (K100654, K072923, and K032145).
- For the Inovise Audicor 12-Lead ECG Interpretive Algorithm, its original 510(k) (K032145) would detail the specific test set and provenance used to establish its performance. This information is not present in the K112761 summary.
- The document implies that "extensive performance testing" was conducted on the integrated device, but no specifics about sample size or data provenance (e.g., country of origin, retrospective/prospective) are provided for this new submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified within the K112761 document for the additional features. This information would typically be detailed in the original submission for the Inovise Audicor 12-Lead ECG Interpretive Algorithm (K032145) if expert review was part of its ground truth establishment.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified within the K112761 document. Again, this would be part of the performance evaluation for the underlying Inovise Audicor 12-Lead ECG Interpretive Algorithm (K032145) at the time of its original clearance.
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 is mentioned for the new features in this 510(k) summary (K112761). The submission is based on substantial equivalence, not a clinical effectiveness study of human-AI collaboration.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- For the Inovise Audicor 12-Lead ECG Interpretive Algorithm, its performance was established as a standalone algorithm in its own original 510(k) (K032145). The current submission integrates this pre-cleared standalone algorithm. The K112761 document notes that 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," indicating it's an assistive tool, not a diagnostic replacement.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified within the K112761 document for the new features. For the Inovise Audicor 12-Lead ECG Interpretive Algorithm, the ground truth would have been established during its original clearance (K032145), likely using expert cardiologists' consensus readings of ECGs, potentially correlated with clinical outcomes or other diagnostic tests depending on the specific conditions the algorithm interprets.
The sample size for the training set:
- Not specified within the K112761 document. The training set size for the Inovise Audicor 12-Lead ECG Interpretive Algorithm would be found in its original 510(k) submission (K032145).
How the ground truth for the training set was established:
- Not specified within the K112761 document. This information would have been part of the original submission for the Inovise Audicor 12-Lead ECG Interpretive Algorithm (K032145), likely involving expert review and annotation of ECGs.

Summary of Approach for K112761:

This 510(k) submission (K112761) demonstrates substantial equivalence by stating that the expanded ZOLL Propaq MD (with new features) is comparable to:

The previous version of the Propaq MD (K100654) for most functions.
The ZOLL E Series (K072923) for AED functionality.
The Inovise Audicor 12-lead Interpretive algorithm (K032145) for the 12-Lead ECG interpretation feature.

For device modifications or integration of pre-cleared components like this, the focus of the 510(k) is often on ensuring that the integration does not negatively impact the performance, safety, or effectiveness established by the predicate devices. Detailed performance studies for the integrated algorithm are typically covered in its original 510(k) submission (K032145 in this case), not re-detailed in subsequent integrations unless significant modifications to the algorithm or its intended use are made. The current document asserts that "Extensive performance testing ensures that the proposed ZOLL Propaq MD performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications," but does not provide details of these tests.

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K Number

K102468

Device Name

ZOLL PROPAQ MD

Manufacturer

Date Cleared

2010-09-30

(31 days)

Product Code

LDD,CCK,DQA,DRO,DRT,DSK,DXN

Regulation Number

870.5300

Type

Special

Panel

Reference & Predicate Devices

k100654

Predicate For

K112432

Intended Use

The Propaq MD 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 Propaq MD. The Propaq MD is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq MD 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 Propag MD unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

ECG Monitoring: The Propaq MD 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.

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 Propag MD 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.

Sp02 Monitoring: The Propaq MD is intended for use to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc.

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

Device Description

The ZOLL Propaq MD was cleared by the agency under 510(k) application K100654 as a multi-parameter monitor / defibrillator / external transcutaneous pacer with the following capabilities: 3, 5 and 12-Lead ECG, pulse oximetery, non-invasive blood pressure, invasive blood pressures, CO2, temperature, data recording and printing. The device is designed for use by trained medical personnel in both out-of-hospital and inhospital applications. The proposed modification adds a filter (SmartCuf) to the existing NIBP algorithm that uses the existing ECG QRS detection to qualify the pressure pulses used in the device NIBP measurement.

AI/ML Overview

The provided 510(k) summary for the ZOLL Propaq MD (K102468) describes a modification to an existing device (K100654), specifically the addition of a filter (SmartCuf) to the Non-Invasive Blood Pressure (NIBP) algorithm. The summary does not include detailed acceptance criteria or a specific study proving the device meets those criteria with numerical performance data. Instead, it relies on substantial equivalence and compliance with a recognized industry standard for the NIBP feature.

Here's an analysis based on the information given, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Parameter	Acceptance Criteria	Reported Device Performance
NIBP (with SmartCuf filter)	Compliance with AAMI SP10 recognized industry standard.	"Extensive performance testing ensures that Propaq MD with the Smartcuf feature performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications. AAMI SP10 testing assures the device NIBP option with the SmartCuf feature continues to comply with the recognized industry standard."
ECG, Defibrillation, Pacing, etc.	"technological characteristics and meets the same specifications of the predicate Propaq MD (K100654)"	Implicitly meets the performance and functional requirements of the predicate device (K100654), as the SmartCuf modification only affects NIBP.

Comments: The document states that the NIBP with SmartCuf feature continues to comply with AAMI SP10. It does not provide specific numerical criteria from AAMI SP10 (e.g., mean difference, standard deviation) or the actual measured performance data against those criteria. For other functionalities, the claim is substantial equivalence to the predicate, implying they meet the same (unspecified in this document) performance criteria as the predicate.

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

This information is not provided in the document. The general statement "Extensive performance testing" does not include details on sample size, data type (retrospective/prospective), or country of origin for any test data.

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

This information is not provided in the document. Given that the primary performance claim relates to an NIBP algorithm's compliance with a standard, it's less likely to involve expert reviewers in the same way an image analysis device would. The "ground truth" for NIBP standards typically involves direct arterial measurements.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically used when combining expert opinions, which is not indicated here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this document. This type of study is more common for diagnostic imaging AI, comparing human performance with and without AI assistance. The described modification is a filter for an NIBP algorithm.

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

Yes, implicitly. The context of "AAMI SP10 testing" for an NIBP algorithm suggests a standalone evaluation of the algorithm's accuracy against a reference standard, without direct human-in-the-loop intervention during the measurement process. The SmartCuf filter modifies the NIBP algorithm itself.

7. The Type of Ground Truth Used

For the NIBP algorithm, the ground truth would typically be invasive arterial blood pressure measurements. While not explicitly stated as "invasive arterial measurements," compliance with AAMI SP10 for NIBP inherently requires comparison against such a gold standard. For predicate equivalence claims, the ground truth would be that established for the predicate device.

8. The Sample Size for the Training Set

This information is not provided in the document. As the SmartCuf is described as a "filter" added to an existing NIBP algorithm, it's unclear if "training data" in the machine learning sense was used, or if it's a rule-based or signal processing modification. If it's a rule-based filter, a distinct training set might not apply in the same way.

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

This information is not provided in the document. If a training set was used, the method for establishing its ground truth (e.g., against invasive arterial measurements) is not detailed.

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K Number

K102174

Device Name

ZOLL PROPAQ M

Manufacturer

Date Cleared

2010-09-15

(44 days)

Product Code

DRT,CCK,DQA,DSK,DXN

Regulation Number

870.2300

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

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

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

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

Device Description

Not Found

AI/ML Overview

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

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

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

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

Here's what can be extracted and what cannot:

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

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

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

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

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

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

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

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

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

No such study was done. This device is a cardiac monitor, not an AI-assisted diagnostic tool. The document describes a medical device for vital sign monitoring, not a system that assists human readers in interpreting images or data. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

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

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

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

8. The sample size for the training set

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

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

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

Summary of what the document does provide:

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

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

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K Number

K100654

Device Name

ZOLL PROPAQ MD

Manufacturer

Date Cleared

2010-07-29

(143 days)

Product Code

LDD,CCK,DQA,DRO,DRT,DSK,DXN

Regulation Number

870.5300

Type

Panel