Search Results

Manual Defibrillation:
Indications
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications
AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Noninvasive Pacing
Indications
Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
12-lead Electrocardiography:
Indications
The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction.
Pulse Oximetry
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
Noninvasive Blood Pressure Monitoring:
Indications
Noninvasive blood pressure monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for postdefibrillation recovery analysis.
End-Tidal CO2 monitoring:
Indications
EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully. It is intended for use on adult and pediatric patients.
Invasive Pressure Monitoring:
Indications
The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system with a compatible transducer. It may be used on the adult or pediatric patient.

The LIFEPAK 12 defibrillator/monitor was designed for use in a variety of hospital and pre-hospital settings including emergency departments. critical care areas, and air and ground ambulances. The LIFEPAK 12 defibrillator/monitor is powered by either AC power or battery power. LIFEPAK 12 defibrillator/monitor features include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry, synchronized cardioversion, noninvasive blood pressure monitoring, end-tidal CO2 monitoring, and invasive pressure monitoring.
The proposed LIFEPAK 12 defibrillator/monitor has the same features and functions as the predicate LIFEPAK 12 defibrillator/monitor and includes an additional battery option; a rechargeable lithium-ion battery. Use of the proposed lithium-ion battery in the LIFEPAK 12 defibrillator/monitor provides an increase in the available operating time and an increase in the number of 360-Joule discharges available while on battery power as compared to using the existing batteries.

The provided document is a 510(k) Premarket Notification for the Physio-Control Inc. LIFEPAK 12 defibrillator/monitor. It focuses on demonstrating substantial equivalence to a predicate device due to the addition of a new battery option (rechargeable lithium-ion battery).

However, the document does not contain acceptance criteria or a study proving the device meets specific performance criteria in the way medical device AI submissions typically do. This submission is for a hardware modification (battery) to an existing device, not a new or modified AI algorithm.

Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truthing, sample sizes for test and training sets, and MRMC studies is not applicable or cannot be extracted from this document.

Here's what can be gathered, and an explanation of why other points are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the document. The submission focuses on substantial equivalence based on a hardware change (battery) where the core functionalities (defibrillation waveform, ECG analysis, monitoring, and defibrillation features) remain unchanged from the predicate device.

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

Not applicable. There isn't a "test set" in the context of evaluating an AI algorithm's performance against ground truth. The testing mentioned would have been related to the safety and performance of the new battery option within the existing device.

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

Not applicable. There is no AI algorithm being evaluated against a ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size:

Not applicable. This document does not describe the evaluation of an AI algorithm's impact on human reader performance.

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

Not applicable. There is no standalone AI algorithm being evaluated.

7. The Type of Ground Truth Used:

Not applicable.

8. The Sample Size for the Training Set:

Not applicable. There is no AI algorithm being trained.

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

Not applicable.

Summary of what the document does state:

• Device: LIFEPAK 12 defibrillator/monitor with a new rechargeable lithium-ion battery option.
• Change: The only difference is an additional rechargeable lithium-ion battery.
• Impact of Change: The new battery provides an increase in available operating time and an increase in the number of 360-Joule discharges compared to existing batteries.
• Unchanged Features: The defibrillation waveform, ECG analysis system, and monitoring and defibrillation features of the proposed device are unchanged from the previously cleared predicate LIFEPAK 12 defibrillator/monitor.
• Conclusion: The submission demonstrates that the LIFEPAK 12 defibrillator/monitor with the new battery is "substantially equivalent to the predicate LIFEPAK 12 device with respect to safety, effectiveness, and performance." This substantial equivalence is the primary "acceptance criterion" for a 510(k) submission, and the "study" is the documentation proving this equivalence through testing relevant to the battery's performance and safety within the device, although specific details of those tests are not in this summary.

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Manual Defibrillation:
Indications
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications
AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Noninvasive Pacing:
Indications
Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
12-lead Electrocardiography:
Indications
The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction.
Pulse Oximetry:
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
Noninvasive Blood Pressure Monitoring:
Indications
Noninvasive blood pressure monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibrillation recovery analysis.
End-Tidal CO2 monitoring:
Indications
EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully. It is intended for use on adult and pediatric patients.
Invasive Pressure Monitoring:
Indications
The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system with a compatible transducer. It may be used on the adult or pediatric patient.

The LIFEPAK 12 defibrillator/monitor was designed for use in a variety of hospital and pre-hospital settings including emergency departments, critical care areas, and air and ground ambulances. The LIFEPAK 12 defibrillator/monitor is powered by either a battery or AC power. LIFEPAK 12 defibrillator/monitor features include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry, synchronized cardioversion. noninvasive blood pressure monitoring, end-tidal CO2 monitoring, and invasive pressure monitoring.
The LIFEPAK 12 defibrillator/monitor has been modified with new setup options in automated external defibrillation (AED) mode to give medical directors or physicians flexibility in establishing their AED protocols including consistency with the recently updated 2005 AHA Guidelines for CPR and ECC.

The provided text describes a 510(k) summary for the Medtronic LIFEPAK® 12 Defibrillator/Monitor, which was modified with new setup options in automated external defibrillation (AED) mode. However, the document does not contain any study data, acceptance criteria for performance, or details about how the device's performance was evaluated against specific metrics.

It primarily focuses on:

• Device Description and Intended Use: Explaining what the LIFEPAK 12 is, its features, and for what purposes it's used.
• Indications for Use and Contraindications: Detailing when each function (Manual Defibrillation, AED, Pacing, ECG, Oximetry, NBP, EtCO2, Invasive Pressure) should be applied and when it should not.
• Substantial Equivalence: Stating that the modified device is substantially equivalent to a previously cleared version, with the only change being new setup options for AED mode.
• Regulatory Information: Classification, contact person, and the FDA's clearance letter.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details because it is not present in the provided text. The document indicates a "Summary of Design Controls" and a "declaration of conformity to design controls," implying that internal testing and validation were performed to support substantial equivalence, but the specifics of these tests (e.g., performance metrics, sample sizes, ground truth establishment) are not included in this 510(k) summary.

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AED mode 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. In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.

Manual Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.

Noninvasive Pacing is indicated for patients with symptomatic bradycardia or asystole.

12-Lead Electrocardiography is useful in the early detection and prompt treatment of patients with acute myocardial infarction.

Pulse Oximetry is used to check the saturation of oxygen in arterial blood. It is indicated for use in any patient who is at risk of developing hypoxemia.

Noninvasive Blood Pressure Monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibrillation recovery analysis.

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

Invasive Pressure Monitoring is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using an invasive catheter system with a compatible transducer.

The LIFEPAK 12 defibrillator/monitor is a complete acute cardiac response system, which consists of a battery or auxiliary powered defibrillator (manual or automated), external pacemaker, ECG monitor (3-lead, 5-lead and interpretive 12-Lead), pulse oximeter, noninvasive blood pressure monitor, end-tidal CO2 monitor, and invasive pressure monitor. Patient data can be transmitted from the LIFEPAK 12 defibrillator to a fax machine, computer, or to a receiving station. This modification changes the pulse oximetry module and sensors used in the LIFEPAK 12 defibrillator/monitor from Nellcor to Masimo.

The provided text does not contain detailed information about specific acceptance criteria and a study that proves the device meets those criteria for the pulse oximetry feature. The document is a 510(k) premarket notification for a modification to the LIFEPAK 12 Defibrillator/Monitor, specifically changing the pulse oximetry module and sensors from Nellcor to Masimo.

The submission claims substantial equivalence to previously cleared devices and mentions design control activities, but it does not include granular data on the performance of the new Masimo pulse oximetry module against predefined acceptance criteria from a study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an attempt to answer based only on the provided information, noting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided text.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified 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 specified, as no study details (like ground truth establishment) are provided for the pulse oximetry performance.

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

• Not specified, as no study details are provided.

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:

• A MRMC study is not mentioned. This device is a defibrillator/monitor with a pulse oximetry feature, not an AI diagnostic tool that human readers would use in conjunction with.

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

• A standalone performance study for the pulse oximetry accuracy is implied by the need for regulatory clearance for a new module, but the details (methodology, results, and whether it's "algorithm only") are not provided in this specific document. The document focuses on substantial equivalence via design control summaries and comparison to predicate devices, rather than a detailed performance study report.

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

• Not specified, as no study details for pulse oximetry accuracy are provided. For pulse oximetry, the typical ground truth would involve co-oximetry measurements from arterial blood gas analysis.

8. The sample size for the training set:

• Not applicable, as this is hardware/firmware modification of a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense.

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

• Not applicable for the same reason as above.

Summary of what the document does provide regarding "proof":

The document primarily states that "This 510(k) includes a summary of design control activities and a declaration of conformity to design controls." and that "The information in this 510(k) notification demonstrates that the modified LIFEPAK 12 defibrillator/monitor is substantially equivalent to the predicate device."

The basis for the pulse oximetry change is that "The modified LIFEPAK 12 uses the same sensors and an updated version of the Masimo SET pulse oximetry module used in the currently marketed LIFEPAK 20 defibrillator/monitor." This implies that the performance of the new Masimo module is already established and cleared through the predicate LIFEPAK 20, and that the "proof" for the LIFEPAK 12 modification relies on this existing equivalence and design control adherence, rather than new, detailed performance study data presented within this 510(k) summary.

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AED mode 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. In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.

Manual Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.

Noninvasive Pacing is indicated for patients with symptomatic bradycardia or asystole.

12-Lead Electrocardiography is useful in the early detection and prompt treatment of patients with acute myocardial infarction.

Pulse Oximetry is used to check the saturation of oxygen in arterial blood. It is indicated for use in any patient who is at risk of developing hypoxemia.

Noninvasive Blood Pressure Monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibrillation recovery analysis.

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

Invasive Pressure Monitoring is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using an invasive catheter system with a compatible transducer.

The LIFEPAK® 12 defibrillator/Monitor/Pacemaker is a complete acute response system, which consists of a battery or auxiliary powered cardiac response system (manual and automated), pacemaker, ECG monitor (3-lead, 5-lead, 5-lead and interpretive 12-Lead), pulse oximeter, noninvasive blood pressure monitor, end-tidal CO2 monitor, and invasive pressure monitor.

The modified LIFEPAK® 12 defibrillator/monitor/pacemaker provides the user with a new method of transmitting data from the LIFEPAK 12 defibrillator; the user can transmit data using either a data transfer cable or wirelessly via Bluetooth® wireless technology.

This 510(k) submission (K040775) is for a modification to the Medtronic Physio-Control LIFEPAK® 12 Defibrillator/Monitor/Pacemaker. The modification involves a new method of transmitting data (data transfer cable or wirelessly via Bluetooth®).

The submission explicitly states that "The features and functions of the LIFEPAK® 12 The reatures and rest/pacemaker are the same as those of the currently marketed LIFEPAK®12 defibrillator/monitor/pacemaker." and "The information in this 510(k) notification demonstrates that the modified LIFEPAK I he mormation in uns 316(tr) neasis substantially equivalent to the predicate device."

This indicates that the device's core functionality (defibrillation, monitoring, pacing, etc.) has not changed, and therefore, no new acceptance criteria, standalone study, or MRMC comparative effectiveness study was required or performed for this specific 510(k) submission. The submission is based on demonstrating substantial equivalence to a previously cleared device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, and ground truth for the modified device is not available in this document as it pertains to the original device's clearance. The current submission focuses solely on the data transmission modification and its substantial equivalence to the predicate.

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The LIFEPAK 500, LIFEPAK CR Plus, and the LIFEPAK 12 and LIFEPAK 20 in automated external defibrillation mode are intended for use on patients in cardiac arrest.

LIFEPAK 12 and LIFEPAK 20 Defibrillator/Monitor/Pacemakers: The AED mode 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.

LIFEPAK 500 Automated External Defibrillator: The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient's ECG rhythm.

LIFEPAK CR Plus Automated External Defibrillator: The LIFEPAK CR Plus defibrillator is indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement).

The LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators are small, portable, battery operated devices intended for treatment of cardiac arrest. Both devices use a patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present. The LIFEPAK 500 and the semi-automatic version of the LIFEPAK CR Plus will then inform the operator if it detects a shockable rhythm and the operator can then press the shock button to deliver energy. The energy is delivered via disposable defibrillation electrodes applied to the chest. The LIFEPAK CR Plus is also available in a fully automatic version which does not require operator interaction to charge and discharge.

The LIFEPAK 12 and LIFEPAK 20 devices use the same shock advising software algorithm as the devices described above. Features available in addition to automated external defibrillation include manual external defibrillation, noninvasive pacing, ECG monitoring, pulse oximetry, and synchronized cardioversion. The LIFEPAK 12 also offers noninvasive blood pressure monitor, invasive blood pressure monitor, and end-tidal CO2 monitor features.

The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria. It is a 510(k) summary for Medtronic Physio-Control defibrillators, focusing on substantial equivalence to previously cleared devices rather than a de novo study with explicit acceptance criteria.

However, based on the general nature of such devices, we can infer some aspects and highlight what information is missing.

Here's an attempt to answer the questions, categorizing what can be inferred and what is explicitly not available in the provided text:

1. A table of acceptance criteria and the 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)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document focuses on substantial equivalence based on prior clearances and the shared algorithm, not new clinical study data details.
• Retrospective or Prospective: Not specified.

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

• Not specified. The document does not describe a study involving human experts establishing ground truth for evaluating the device's performance.

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

• Not specified. As no expert ground truth establishment for a test set is detailed, no adjudication method is mentioned.

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, an MRMC comparative effectiveness study is not mentioned. This document is for a 510(k) clearance based on substantial equivalence, not a new comparative effectiveness study with human readers and AI assistance. The devices include an "automated external defibrillator" (AED) mode, implying the algorithm is the primary decision-maker for shock advice, not an "AI assistance" for human readers in a diagnostic capacity.

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

• Yes, implicitly. The core of the AED functionality described relies on a "patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present." While some devices (LIFEPAK 500 and semi-automatic CR Plus) then require operator interaction to press a shock button, the analytical part of the decision-making is automated. The fully automatic CR Plus explicitly "does not require operator interaction to charge and discharge." The substantial equivalence argument rests on this existing, cleared algorithm's performance.

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 validation of the "patented software algorithm." However, for AEDs, ground truth for shockable rhythms (Ventricular Fibrillation (VF) and rapid Ventricular Tachycardia (VT)) is typically established by:
  • Expert Consensus: Review of ECG waveforms by cardiologists or electrophysiologists.
  • Physiological Correlation: In some research contexts, correlation with actual cardiac activity or response to defibrillation.
  • Standardized Databases: Often, development and validation use large, annotated ECG databases derived from various clinical situations.

8. The sample size for the training set

• Not specified. The document describes existing algorithms and devices, not the details of their initial training data.

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

• Not specified. As with the test set ground truth, the document refers to a "patented software algorithm" and its performance in previously cleared devices, but does not detail the methodology for establishing ground truth during its original development and training.

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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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