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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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Use the Infant/Child defibrillation electrodes on an infant or child up to 8 years old or up to 25kg (55lbs). Do not delay therapy to determine child's exact age or weight.

These electrodes are to be used only with LIFEPAK CR PLUS defibrillators and biphasic LIFEPAK® 500 AEDs configured with a pink cable connector.

The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are indicated for use 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.

The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.

The attenuating electrode is designed to allow minimally trained responders to safely and effectively defibrillate infants and children under 8 using the LIFEPAK® CR Plus or biphasic LIFEPAK 500 AEDs manufactured after a certain date. (Compatible biphasic LIFEPAK 500 AEDs can be identified by the pink connector on the AED.)

The Infant / Child Reduced Energy Electrode assembly consists of currently marketed Pediatric QUIK-COMBO electrode pads, wires, a connector, and an attenuator. The attenuator is comprised of multiple resistors and a surge protector mounted on a PCB and installed in a flat plastic case.

The attenuator reduces the standard "adult" AED energy at a ratio of about 4 to 1. When used with the Infant / Child Reduced Energy electrodes, an AED set to deliver 200J first shock, 300J second shock, and 360J third shock for adult patients, will instead deliver about 50, 75, and 86J.

Here's a breakdown of the acceptance criteria and study information for the Medtronic Physio-Control Infant/Child Reduced Energy Electrodes, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on substantial equivalence to predicate devices rather than explicit, quantitative acceptance criteria for all performance metrics. However, it does outline the energy reduction ratio, which is a key performance characteristic.

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

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms" and "Non-Clinical testing of energy dosing" but does not specify:

• The exact sample size used for the test set in either category.
• The country of origin of the data.
• Whether the data was retrospective or prospective.

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

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms" but does not specify:

• The number of experts used to establish ground truth.
• The qualifications of those experts.

4. Adjudication Method for the Test Set

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms" but does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

A MRMC comparative effectiveness study was NOT mentioned or described in the provided text. The submission focuses on the performance of the device itself and its substantial equivalence to predicate devices, rather than measuring the improvement of human readers with AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms," which suggests a standalone evaluation of the algorithm's performance in analyzing ECG rhythms. However, further details on how this was conducted (e.g., specific metrics, comparison to human interpretation) are not provided. The primary focus seems to be the algorithm's ability to accurately identify pediatric rhythms for the defribrillator.

7. Type of Ground Truth Used

The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms." For ECG rhythm analysis, the ground truth is typically established by expert consensus of cardiologists or electrophysiologists on the rhythm strips. However, the document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set

The document does NOT provide any information regarding the sample size used for the training set for the algorithm.

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

The document does NOT provide any information on how the ground truth for the training set was established.

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

The biphasic waveform has only been clinically studied on adults; it has not been studied on pediatric patients.

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.

In AED mode, the LIFEPAK 20 defibrillator/monitor is not intended for use on pediatric patients less than eight years old.

Noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.

Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.

The LIFEPAK 20 device is a defibrillator/monitor primarily intended for the hospital and clinic setting. It is easy to use, portable, easy to maintain, and fits comfortably on a gurney during transport. It has a built in AC power supply and backup NiMH battery. It uses a biphasic waveform with an energy range from 2 - 360 Joules.

Features and options include: external noninvasive pacemaker; pulse oximeter; 3-, 6-, and 7-lead ECG; defibrillation paddles; ability to use all disposable electrodes or paddles currently used with the LIFEPAK 12 defibrillator/monitor/pacemaker; internal paddles capability; 50 mm printer; automated external defibrillator mode; built in AC power with NiMH battery backup; digital remote synchronization to bedside monitor; and an infrared and serial ports for data download.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medtronic Physio-Control LIFEPAK 20 Defibrillator/Monitor:

Overall Assessment:

The provided document (510(k) Premarket Notification) for the LIFEPAK 20 primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (LIFEPAK 9P and LIFEPAK 12). This means that instead of conducting new, extensive clinical studies to prove effectiveness and safety from scratch, the manufacturer argues that the new device is as safe and effective as existing, legally marketed devices.

Therefore, the document does not describe specific acceptance criteria and detailed study results in the manner one might expect for a de novo device submission where new performance metrics are established and then proven through dedicated trials. Instead, it relies on compliance with recognized standards and the inherent equivalence to predicate devices that have already met regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance:

Given the nature of this 510(k) submission, a direct table of "acceptance criteria" against "reported device performance" (in the sense of specific clinical endpoints with numerical targets) is not explicitly provided. The acceptance criteria are implicitly tied to:

• Compliance with recognized standards: AAMI, IEC, and ISO standards for defibrillators, monitors, and pulse oximeters.
• Substantial equivalence to the predicate devices in terms of safety, effectiveness, and performance.

The document states that these criteria are met, but does not provide specific performance data points in a table format.

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

The document does not describe a specific "test set" or a new clinical study with a defined sample size for the LIFEPAK 20 itself. Instead, it relies on the established performance of its predicate devices and compliance with international standards.

• Sample Size for Test Set: Not applicable or not specified for a new, dedicated study. The evidence is based on the general acceptance of the predicate devices and standard compliance.
• Data Provenance: Not applicable in the sense of a new clinical trial. The "data" stems from the validation/clearance of the predicate devices and the technical verification processes (likely in-house testing) to ensure compliance with standards.

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

This information is not provided. Since no new clinical "test set" (in the sense of patient data requiring expert ground truth) is described for the LIFEPAK 20's performance validation, there's no mention of experts or their qualifications for establishing ground truth for a novel dataset.

4. Adjudication Method for the Test Set:

Not applicable, as no new clinical "test set" requiring expert adjudication is described in this 510(k) summary.

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

No, an MRMC comparative effectiveness study is not mentioned or described in the provided text.

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

The LIFEPAK 20 is a medical device that includes various functions (defibrillation, monitoring, pacing, oximetry). While it has an "automated external defibrillator mode," the document does not describe a separate "standalone algorithm" performance study in the context of AI or advanced diagnostic algorithms. Its "automated" function would have been validated as part of its overall design and compliance with AED standards.

7. The Type of Ground Truth Used:

For the LIFEPAK 20 itself, the "ground truth" for its performance is implicitly derived from:

• Compliance with established performance standards (AAMI, IEC, ISO): These standards define performance requirements that are met through engineering validation and testing.
• Performance of predicate devices: The predicate devices (LIFEPAK 9P, LIFEPAK 12) have already undergone their own regulatory clearance, which would have involved demonstrating effectiveness and safety, potentially using clinical data, expert consensus, or other forms of ground truth suitable for those devices at their time of submission.

There's no mention of pathology, explicit expert consensus on a novel dataset for the LIFEPAK 20, or outcomes data specific to the LIFEPAK 20's primary 510(k) submission.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its design and functionality are based on engineering principles and established medical science, not on a machine learning model trained on a dataset.

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

Not applicable, as there is no "training set" for this type of device.

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The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The The In Life In First 500 rassious, not breathing normally and showing no signs of circulation (for example, no pulse, no coughing, no movement) before the device is used to analyze the patient's ECG rhythm. This device is not intended for use on children less than eight years of age, per AHA/ILCOR Guidelines.

The LIFEPAK 500 Automated External Defibrillator (AED) is a portable battery powered, low energy defibrillator that applies a pulse of electricity to the heart via disposable defibrillation electrodes on the chest. A patented software algorithm analyzes the patient's electrocardiogram (ECG) and informs the operator if it detects a shockable rhythm. The operator can then press the shock button to deliver energy.

This 510(k) summary (K012428) primarily concerns a change to the operating instructions and voice prompts of the LIFEPAK 500 Automated External Defibrillator (AED) to align with updated American Heart Association Guidelines 2000 for CPR and ECC.

Therefore, the submission does not contain information about a new performance study to establish acceptance criteria or device performance for a new algorithm or a new hardware feature. Instead, it relies on the predicate devices' prior clearances.

The device (LIFEPAK 500 AED) is already cleared, and this submission is a Special 510(k) for a modification to its user interface and instructions, not a fundamental change to its shock advisory algorithm or defibrillation waveforms. The document explicitly states: "The shock advisory algorithm, defibrillation waveforms, etc. are all the same."

Given this context, I will extract the information available and note where specific details regarding a new performance study are not applicable or not provided.

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is for a modification to operating instructions and voice prompts, rather than a new performance study for the core defibrillation algorithm, a table of new acceptance criteria and new reported device performance (e.g., sensitivity, specificity for rhythm analysis) is not provided in this document. The device relies on the existing performance data from its predicate devices (K983393 and K955854). The relevant "performance" being updated here is the user's interaction with the device based on new guidelines.

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

Not applicable for a new performance study related to algorithm accuracy, as the algorithm itself is unchanged.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable for a new performance study related to algorithm accuracy, as the algorithm itself is unchanged. The rationale for the instructional changes comes from the American Heart Association Guidelines 2000 for CPR and ECC, which would have been developed by medical experts.

4. Adjudication Method for the Test Set

Not applicable for a new performance study related to algorithm accuracy.

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

No. This type of study would typically be conducted for imaging or diagnostic algorithms where human reader performance is a factor. This submission pertains to a defibrillator's operating instructions.

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

No. The defibrillation algorithm's standalone performance, such as sensitivity and specificity for shockable rhythms, was established during the clearance of its predicate devices (K983393 and K955854), as the algorithm remains "the same."

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the original algorithm development and validation (of the predicate devices), the ground truth for cardiac rhythm analysis would typically be established by expert cardiologists reviewing ECG recordings. However, for this specific 510(k), the "ground truth" for the changes in operating instructions and prompts is based on clinical guidelines and recommendations from the American Heart Association Guidelines 2000 for CPR and ECC. These guidelines are developed through extensive review of medical evidence and expert consensus.

8. The Sample Size for the Training Set

Not applicable for this 510(k). The device's algorithm was developed and trained prior to this submission.

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

Not applicable for this 510(k). For the original algorithm, ground truth would have been established by expert cardiologists analyzing ECG data used for 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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