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Defibrillation is a means of terminating ventricular fibrillation and ventricular tachycardia. The biphasic waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients. The AED mode is for use on patients in cardiopulmonary arrest. Pacing is used to treat symptomatic bradycardia and asystole. ECG monitoring is used for identifying and diagnosing cardiac rhythms and dysrhythmias and calculating heart rate. Pulse oximetry is used to check the saturation of in the arterial blood of patients who are at risk of developing hypoxemia.

The LIFEPAK 12 defibrillator/monitor series is a complete acute cardiac response system - battery or auxiliary powered defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provided does not contain specific, quantifiable acceptance criteria or a direct table comparing them to reported device performance. The entire summary focuses on demonstrating "substantial equivalence" rather than meeting pre-defined performance metrics through a detailed study report.

However, based on the description, the core "performance" being highlighted is the efficacy of the Biphasic Truncated Exponential (BTE) waveform for defibrillation.

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

• Sample Size: Not explicitly stated in the provided text. The document only mentions a "multi-site clinical study" for the efficacy of the BTE waveform.
• Data Provenance: Not explicitly stated. It refers to a "multi-site clinical study," which generally implies prospective data collection, but no details on the specific countries or retrospective/prospective nature are provided.

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

• Number of Experts: Not applicable/not mentioned. This device (a defibrillator) does not rely on human interpretation of outputs to establish ground truth in the same way an AI diagnostic tool would. The efficacy (success of defibrillation) would be measured by physiological outcomes.
• Qualifications of Experts: Not applicable/not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/not mentioned. As above, this device's performance is measured by its direct physiological effect (e.g., termination of arrhythmia), not by human interpretation requiring consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a manual and automated external defibrillator/monitor/pacemaker, not an AI-assisted diagnostic tool that would improve human reader performance. Its function is to deliver therapy and monitor physiological signals.

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

• Standalone Performance: The core efficacy evaluation described relates to the Biphasic Truncated Exponential (BTE) waveform of the defibrillator itself, not a separate "algorithm only" performance for an interpretive component. While the device has an "Interpretive 12-lead ECG," the study described specifically addresses the defibrillation waveform. The AED mode certainly has an algorithm for rhythm analysis, but its standalone performance metrics are not detailed, beyond stating it "analyzes the patient's ECG rhythm." The clinical study mentioned focuses on the biphasic waveform efficacy.

7. The Type of Ground Truth Used:

• Type of Ground Truth: For the defibrillation efficacy study, the ground truth would be clinical outcomes data related to the termination of ventricular fibrillation and ventricular tachycardia. This would likely involve observing the patient's rhythm post-shock.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable/not mentioned. This device's core claim (biphasic waveform efficacy) is based on fundamental physiological principles and prior clinical validation, not on a machine learning model that requires a training set in the conventional sense. While the AED component has an algorithm, no details on its training were provided.

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

• Ground Truth Establishment: Not applicable/not mentioned, as there is no explicitly defined "training set" for an AI model. For the AED algorithm, the "ground truth" for training would likely involve expert-labeled ECG rhythms (e.g., cardiologists classifying rhythms as shockable/non-shockable) if it were a machine learning algorithm. However, this is not detailed in the provided text.

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NIBP

The LIFEPAK®12 NIBP monitor non-invasively measures blood pressure of the adult and pediatric patients by professionally trained health care providers. It is not designed for continuous, unsupervised monitoring.

EtCO2

The use of the LIFEPAK®12 EtCo2 monitor is indicated whenever professionally trained health care providers determine that a patient requires the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.

The LIFEPAK®12 defibrillator / monitor series is a complete acute cardiac response system - battery or auxiliary powered defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system.
The users will be Advanced Life Support and Basic Life Support providers in a variety of hospital and pre-hospital settings. Emergency Medical Services users will include Paramedics and Emergency Medical Technicians trained and authorized to respond to medical emergencies. This device will be used in the pre-hospital setting and in the hospital, in critical areas (emergency departments, critical care, operating rooms, etc.) and on general duty floors (e.g. medical/surgical). It will also be used for patient transport (air and ground ambulance, in hospital transport, etc.)

Here's an analysis of the provided text regarding the acceptance criteria and study data for the NIBP and CO2 Options for the Physio-Control LIFEPAK®12 Defibrillator / Monitor System:

Based on the provided 510(k) summary, specific, quantitative acceptance criteria and the detailed study that proves the device meets those criteria are not explicitly described in the provided text. The document focuses primarily on establishing substantial equivalence to predicate devices and adherence to industry standards, rather than presenting a standalone performance study with detailed acceptance criteria and results.

However, we can infer some information from the text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit quantitative acceptance criteria are not provided. The document states that the device is subject to "extensive safety and performance testing" and that "Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."

The closest we get to "acceptance criteria" are the standards to which the device complies, implying that meeting the requirements of these standards constitutes acceptable performance.

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

• Sample Size for Test Set: Not specified. The document mentions "performance tests" and "safety testing" but does not provide any details about the number of subjects or cases used in these tests.
• Data Provenance: Not specified. There is no information provided about the country of origin of any testing data, nor if the data was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. There is no mention of any expert consensus or adjudication process for establishing ground truth during testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study: No. The provided text does not mention any multi-reader multi-case comparative effectiveness study or any evaluation of human reader improvement with or without AI assistance. This document describes a modification to a medical device (defibrillator/monitor) with NIBP and CO2 options, which are sensors/measurement tools, not AI-driven diagnostic interpretation tools.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance Study: The document focuses on the device's performance in meeting standards and functional specifications. While "performance tests" are mentioned for the system, it's not described as an "algorithm only" study in the context of typical AI/software device standalone performance. The NIBP and CO2 functions are direct measurements, not an algorithm providing a diagnosis or interpretation that would typically have a "standalone" or "human-in-the-loop" comparison.

7. The Type of Ground Truth Used

• Type of Ground Truth: This is not explicitly stated as pathology, outcomes data, or expert consensus in the traditional sense. For NIBP and CO2 measurement, the "ground truth" would typically refer to accepted, gold-standard reference measurement methods. The document states compliance with standards like ANSI/AAMI SP-10-1992 and EN 864, which themselves define reference methods and accuracy requirements for such measurements. Therefore, the ground truth would be implicitly derived from these established reference measurement techniques as per the specified standards.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. This document describes a hardware device with integrated measurement capabilities (NIBP and CO2). There is no mention of an AI algorithm that would require a "training set" in the context of machine learning.

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

• Ground Truth for Training Set: Not applicable/Not specified. As there's no mention of a machine learning component requiring a training set, this information is not relevant to the provided text.

In summary: The 510(k) summary provided focuses on establishing substantial equivalence to predicate devices and adherence to recognized performance and safety standards. It does not contain the detailed, quantitative efficacy study results, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in submissions for novel diagnostic algorithms or AI-driven systems. The "studies" referred to are generally compliance tests against established engineering and medical device standards.

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The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. It is not intended for use on children less than eight years of age, per Att A quidelines .

The Biphasic LIFEPAK 500 Automated External Defibrillator (AED) is a portable battery powered device which applies a brief, high energy pulse of electricity to the heart via defibrillation electrodes on the chest. A software algorithm analyzes the patients electrocardiogram (ECG) and informs the operator whether it detects a shockable rhythm. The operator can then press the shock button to deliver energy after confirming that the patient is unconscious, pulseless and apneic.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medtronic Physio-Control Corporation Biphasic LIFEPAK® 500 Automated External Defibrillator:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format, nor does it provide a direct table of reported device performance against such criteria. Instead, it states that the device is "substantially equivalent" to predicate devices and complies with relevant AAMI standards.

The primary performance metric mentioned is the "efficacy of the biphasic truncated exponential waveform."

Study Details from the Provided Text:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in the provided text. The text mentions a "multisite clinical study" but does not give the number of patients or events.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "multisite clinical," suggesting it involved multiple locations, but specific geographic regions are not mentioned. It is implied to be prospective since it's a clinical study to demonstrate efficacy for a new waveform.

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

   • This information is not provided in the given text.

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

   • This information is not provided in the given text. The description focuses on the device's waveform efficacy rather than a diagnostic algorithm requiring expert adjudication of outputs.

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

   • No background for MRMC study: The device is an Automated External Defibrillator (AED), which relies on an algorithm to analyze the patient's ECG and inform the operator. It's not a diagnostic imaging device where human readers interpret results aided by AI. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable in this context and was not done according to the provided information.

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

   • Yes, in essence. The core of the device is its "software algorithm [that] analyzes the patients electrocardiogram (ECG) and informs the operator whether it detects a shockable rhythm." The "efficacy of the biphasic truncated exponential waveform" was demonstrated in a clinical study. This efficacy relates to the device's ability to successfully defibrillate, which is a direct outcome of its core function (waveform delivery) after the algorithm identifies the rhythm. While a human delivers the shock, the critical step of rhythm analysis and energy delivery (waveform) is automated; therefore, the clinical study essentially evaluates the standalone performance of the device's ability to treat shockable rhythms.

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

   • The ground truth for evaluating AEDs typically involves clinical outcomes data (e.g., successful termination of ventricular fibrillation/tachycardia, return of spontaneous circulation, survival to discharge) as observed in a clinical setting. The statement "The efficacy of the biphasic truncated exponential waveform was demonstrated in a multisite clinical study" strongly implies the use of such outcomes data as ground truth. The algorithm's accuracy in identifying shockable rhythms would also be a critical part of the ground truth, likely established by comparison to physician-interpreted ECGs or established rhythm classifications.

7. The sample size for the training set:

   • This information is not provided in the given text. The summary focuses on the substantial equivalence and clinical validation of the new waveform, not the internal development or training of the ECG analysis algorithm.

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

   • This information is not provided in the given text. Similarly to the training set sample size, details about the algorithm's development or training ground truth are outside the scope of this 510(k) summary.

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Defibrillation is a means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. The AED mode is for use on patients in cardiopulmonary arrest. Pacing is used to treat symptomatic bradycardia and asystole. ECG monitoring is used for identifying and diagnosing cardiac rhythms and dysrhythmias and calculating heart rate. Pulse oximetery is used to check the saturation of in the arterial blood of patients who are at risk of developing hypoxemia.

The LIFEPAK 12 defibrillator/monitor series is a complete acute cardiac response system - battery or auxiliary powered defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system

The provided 510(k) summary for the Physio-Control LIFEPAK® 12 defibrillator/monitor/pacemaker system does not contain a detailed study with specific acceptance criteria and performance results in the format requested.

Instead, the document states that "Information is provided in the 510(k) regarding compliance to applicable sections of the following voluntary industry standards and FDA guidance documents:" followed by a list of standards for diagnostic electrocardiographic devices, cardiac monitors, cardiac defibrillator devices, and automatic external defibrillators. It concludes by saying, "This information demonstrates that the LIFEPAK 12 is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance."

Therefore, based on the provided text, I cannot complete the table and answer all points as specific study details are not given. The submission relies on compliance with existing industry standards rather than a new standalone clinical study with explicit acceptance criteria and corresponding performance metrics for the device itself.

Here's a breakdown of what can and cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document refers to compliance with industry standards, but does not list specific numerical acceptance criteria or performance metrics for the LIFEPAK 12 itself beyond stating substantial equivalence to predicate devices.

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

Not available in the provided text.

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

Not available in the provided text.

4. Adjudication method for the test set

Not available in the provided text.

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

Not applicable. The device described is a defibrillator/monitor/pacemaker system, not an AI-assisted diagnostic tool that would typically involve human readers.

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

This is not explicitly stated in the context of a "study" with performance metrics. The device's automated functions (like AED mode) would inherently operate in a "standalone" fashion, but performance data is not provided.

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

Not available in the provided text.

8. The sample size for the training set

Not available in the provided text.

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

Not available in the provided text.

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For emergency treatment of patients in cardiac arrest who are unconscious and lack pulse and spontaneous breath. The device may be used for automated ECG analysis or, alternatively as a standard cardiac monitor for manual BCG assessment.

The LIFEPAK 300 is a portable external cardiac defibrillator. It can operate in either the semi-automated mode or the manual mode. A lesser trained emergency responder such as an EMT can use the device in the semi automated mode; the device analyzes the cardiac rhythm and indicates "shock advised" if it detects a shockable rhythm. If the device is in the manual mode a person trained in cardiac rhythm interpretation, such as a paramedic, can deliver a defibrillation shock without relying on the automated analysis of the device.

This document describes the acceptance criteria and supporting study for the Physio-Control Corporation LIFEPAK 300 automated external defibrillator (modified) (K962359).

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a readily extractable format. It mentions "qualification testing and software/system validation testing" were provided. However, the key modification and implied performance relates to the device's ability to allow shock delivery in the presence of motion if a shockable rhythm is detected, which the unmodified version would not. Without explicit performance data provided in the summary, we cannot create a precise table.

Implied Performance Focus: The primary functional change is allowing shock delivery in the presence of motion when a shockable rhythm is detected, unlike the predicate device. The performance would be assessed on the accuracy of rhythm analysis under these specific conditions.

2. Sample Size and Data Provenance for Test Set

The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "qualification testing and software/system validation testing."

3. Number and Qualifications of Experts for Ground Truth (Test Set)

The 510(k) summary does not specify the number of experts used to establish ground truth for the test set or their qualifications.

4. Adjudication Method for Test Set

The 510(k) summary does not describe any adjudication method used for establishing ground truth on the test set.

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

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is an automated external defibrillator, and its performance evaluation typically focuses on the accuracy of its automated rhythm analysis, rather than human reader improvement with AI assistance.

6. Standalone Performance Study

Yes, a standalone study of the algorithm's performance was implied by the mention of "qualification testing and software/system validation testing." The device operates in a "semi-automated mode" where it "analyzes the cardiac rhythm and indicates 'shock advised' if it detects a shockable rhythm." This indicates that the algorithm's ability to accurately detect shockable rhythms is a core performance characteristic assessed in standalone mode. However, specific metrics of this standalone performance are not provided.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated. However, given the nature of an automated external defibrillator, the ground truth for rhythm analysis in testing would typically be established by:

• Expert Consensus: Review of ECG waveforms by qualified cardiologists or electrophysiologists.
• Known Rhythm Libraries: Using pre-recorded ECGs with confirmed diagnoses of shockable (e.g., ventricular fibrillation, pulse-less ventricular tachycardia) and non-shockable rhythms.
• Experimental/Simulated Data: Where the cardiac rhythm can be precisely controlled and known.

8. Sample Size for Training Set

The 510(k) summary does not provide details on the sample size for any training set used for the device's software/algorithm. This information is typically not detailed in the public 510(k) summary for such devices unless it's a novel AI/ML device where this is a primary focus.

9. How Ground Truth for Training Set Was Established

The 510(k) summary does not provide details on how the ground truth for any training set was established. Similar to the test set, it would likely involve expert review of ECGs, known rhythm databases, or controlled experimental data.

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The LIFEPAK 500 Automated External Defibrillator may be used in the hospital or pre-hospital setting by authorized personnel to terminate certain potentially fatal cardiac arrhythmias.

The LIFEPAK 500 Automated External Defibrillator (AED) is a portable battery powered device which applies a brief, high energy pulse of electricity to the heart via defibrillation electrodes on the chest. A software algorithm analyzes the patients electrocardiogram (BCG) and informs the operator whether it detects a shockable rhythm. The operator can then press the shock button to deliver energy after confirming that the patient is unconscious, pulseless and apneic.

The provided text, a 510(k) summary for the Physio-Control LIFEPAK 500 Automated External Defibrillator (AED), focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting the acceptance criteria and a detailed study proving the device meets those criteria from an AI/algorithm performance perspective.

Here's an attempt to extract and infer the requested information based on the provided text, recognizing that some details might be missing or require interpretation:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the nature of an AED and the AAMI standards cited, the core acceptance criteria for the arrhythmia detection algorithm would be related to its ability to correctly identify shockable rhythms (sensitivity) and non-shockable rhythms (specificity). The document states the device uses the same arrhythmia detection algorithm that is used in the LIFEPAK 300 AED, implying that the performance met the criteria established for the predicate device. However, specific numerical thresholds for sensitivity and specificity are not explicitly stated in this excerpt.

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

The document does not explicitly state the sample size (number of ECG rhythms/cases) used for the rhythm detection algorithm's test set. It also does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the excerpt. For an AED's rhythm analysis, ground truth for a test set would typically involve expert cardiologists or electrophysiologists labeling ECGs.

4. Adjudication Method for the Test Set

This information is not provided in the excerpt. Common adjudication methods include 2+1 (two agree, one breaks ties) or 3+1 (three agree, one breaks ties).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This document describes a device submission for an AED with an automatic external defibrillator function. The focus is on the algorithm's performance in detecting shockable rhythms, not on assisting human readers in interpreting ECGs. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable and not mentioned. The device's primary function is standalone rhythm analysis followed by operator action.

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

Yes, a standalone performance evaluation of the algorithm's rhythm detection capabilities was implicitly done. The statement "A software algorithm analyzes the patients electrocardiogram (BCG) and informs the operator whether it detects a shockable rhythm" and "rhythm detector function" tests indicate that the algorithm's performance in analyzing ECGs independently was assessed. The 510(k) process for devices like AEDs heavily relies on the standalone accuracy and reliability of their algorithms.

7. The Type of Ground Truth Used

While not explicitly stated, for an AED's rhythm detection algorithm, the most appropriate and likely ground truth would be expert consensus by cardiologists or electrophysiologists based on detailed ECG analysis and potentially clinical correlation from the patients' records. Pathology or outcomes data would be less direct for the rhythm detection algorithm's ground truth, though overall device effectiveness would be linked to outcomes.

8. The Sample Size for the Training Set

This information is not provided in the excerpt.

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

This information is not provided in the excerpt. Similar to the test set, it would typically involve expert review and labeling of ECG data.

In summary of the limitations of the provided text:

The 510(k) summary is designed to demonstrate substantial equivalence, not to detail the full performance study of the algorithm's development and validation in the way a more comprehensive study publication might. It confirms that the device meets relevant standards and that the algorithm is the same as a previously cleared device, implying its performance has been sufficiently validated. Specific metrics for the algorithm's sensitivity and specificity, along with details about the test/training data, expert adjudication, and ground truth establishment, are not included in this high-level summary.

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