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The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are intended for use in the hospital, physician's office, and clinic setting by personnel who are authorized by a physician/medical director. Thev are intended for use on a "crash cart" as well as for portable emergency response throughout a hospital.

Indications for Use (for both the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors):

Manual Defibrillation
Indications: Defibrillation is a recognized means of terminating 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.
Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular escape rhythms, and in the treatment of asystole.

Automated External Defibrillation:
Indications: The 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 20 (and LIFEPAK 20e) 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.

Pulse Oximetry
Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.

End-Tidal CO2 monitoring:
Indications: EtCO2 monitoring is used to detect 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.

The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors were designed especially for hospitals and clinics for use on "crash carts" as well as for portable emergency response throughout a hospital. Features of the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-wire or 5-wire), pulse oximetry, and synchronized cardioversion. The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are powered by AC power and a backup internal battery. The LIFEPAK 20 defibrillator/monitor utilizes a nickel-metal hydride internal battery while the LIFEPAK 20e defibrillator/monitor utilizes a lithium-ion internal battery. The LIFEPAK 20e defibrillator/monitor also has a battery status indicator on the device screen.

In addition to the features described above, the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors have a new CO2 monitoring feature, CPR metronome feature, wireless data transmission capability and a new optional accessory named the CodeManagement Module™.

This document describes the Physio-Control LIFEPAK® 20 defibrillator/monitor and LIFEPAK® 20e defibrillator/monitor. The notification focuses on a new CO2 monitoring feature and a CPR metronome feature added to these existing devices.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the new features in the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are similar to the CO2 monitoring and CPR metronome features in the predicate LIFEPAK 15 monitor/defibrillator.

The conclusion of testing states: "The information in this 510(k) notification demonstrates that the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are substantially equivalent to the predicate LIFEPAK 20 defibrillator/monitor, LIFEPAK 20e defibrillator/monitor and the LIFEPAK 15 monitor/defibrillator with respect to safety, effectiveness, and performance."

Since the primary claim for the new features is substantial equivalence to existing predicate devices, the "acceptance criteria" are implicitly met by demonstrating that the new features function comparably to the predicate device, the LIFEPAK 15 monitor/defibrillator. The provided text does not explicitly list quantitative acceptance criteria for the CO2 monitoring or CPR metronome features, nor does it provide a table of "reported device performance" in terms of specific metrics like accuracy, sensitivity, or specificity for these new features. Instead, it relies on the established performance of the predicate device.

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

• Sample Size: Not specified. The document states "Performance testing of the proposed devices consisted of bench testing."
• Data Provenance: Not specified, but generally, bench testing would involve laboratory-generated or simulated data. It does not mention real patient data or country of origin.
• Retrospective/Prospective: Not applicable as no clinical studies were performed.

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

• Not applicable. No experts or ground truth establishment relevant to algorithm performance (like image interpretation) using a test set is described. The evaluation was bench testing based on substantial equivalence.

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

• Not applicable. No human adjudication for a test set is described.

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. The document explicitly states: "No clinical studies or non-clinical (i.e. animal) studies were submitted as part of this 510(k) notification." This means no MRMC study was conducted.

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

• Yes, in a sense, as the performance testing described as "bench testing" would evaluate the device's CO2 monitoring and CPR metronome features independently, likely against known physiological parameters or simulated conditions. However, the exact methodology and metrics are not detailed beyond "bench testing."

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

• For "bench testing," the ground truth would typically be established by known, controlled inputs (e.g., a gas mixture with a specific CO2 concentration, or a mechanical device simulating CPR compressions at a known rate). The document does not specify the exact nature of the ground truth for the bench testing, but it would not be expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. The document describes a 510(k) submission for device modifications (CO2 monitoring and CPR metronome) based on substantial equivalence to a predicate device. It is not an AI/ML algorithm requiring a training set in the conventional sense. The features are presented as being "similar to" those in the predicate, implying established engineering principles and likely internally validated existing algorithms from the predicate device.

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

• Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician's office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a "crash cart" as well as for portable emergency response throughout a hospital.

Manual Defibrillation:
Indications: Defibrillation is a recognized means of terminating certain 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.
Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular escape rhythms, and in the treatment of asystole.

Automated External Defibrillation:
Indications: The 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.

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.

Pulse Oximetry
Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.

The LIFEPAK 20 defibrillator/monitor was created especially for hospitals and clinics for use on "crash carts" as well as for portable emergency response throughout a hospital. The LIFEPAK 20 defibrillator/monitor is equipped with AC power and a backup internal battery. Features of the LIFEPAK 20 defibrillator/monitor include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-wire or 5-wire), pulse oximetry, and synchronized cardioversion.

The LIFEPAK 20 defibrillator/monitor has been modified with new battery technology. This modification includes a change in the chemistry of the internal battery from nickel-metal hydride to lithium ion, and the addition of a battery status indicator on the device display indicating the approximate amount of operating time available while using battery power.

The model name of devices with this new battery technology is the LIFEPAK 20e defibrillator/monitor.

The provided text describes a 510(k) premarket notification for the Physio-Control Inc. LIFEPAK 20e defibrillator/monitor. This submission focuses on modifications to an existing device, the LIFEPAK 20, specifically changing the internal battery chemistry and adding a battery status indicator.

Based on the provided information, a traditional "study" proving device performance against acceptance criteria, as one might expect for a novel AI device or a device with new clinical functionality, is not described. The submission leverages the substantial equivalence pathway, asserting that the new device's core functionalities (ECG analysis, defibrillation waveform, noninvasive pacing) are identical to the already cleared predicate device (LIFEPAK 20). The focus of this 510(k) is the battery change and its associated indicator.

Therefore, the acceptance criteria and supporting study are framed around demonstrating that the new battery technology does not adversely affect the device's existing, cleared performance and that the new battery indicator functions as intended.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with reported numerical performance for the LIFEPAK 20e. Instead, it states that the technological characteristics of the new device's core functions (ECG analysis system, defibrillation waveform, and noninvasive pacing) are the same as those of the predicate device. This implies that the acceptance criteria for these functionalities are met by virtue of being identical to the cleared predicate.

The main change is the battery, and the acceptance criterion implicitly relates to the battery's ability to power the device and its status indicator.

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

The document does not specify a sample size for a test set in the context of clinical or performance data for the battery or the overall device performance. Given that the core functionalities are asserted to be identical to the predicate, it's highly probable that performance testing for the battery would involve bench testing and electrical safety assessments rather than a clinical "test set" with patient data.

The data provenance is not explicitly mentioned but would be from Physio-Control Inc.'s internal testing and design control activities, as implied by "Summary of Design Controls" and "declaration of conformity to design controls."

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

Given the nature of the submission (a battery change in an existing, cleared device), there is no mention of "experts" being used to establish ground truth in the way one would for a diagnostic AI algorithm. The performance of the underlying defibrillation, ECG, and pacing technologies is assumed to be established by the predicate device's clearance. For the battery component, electrical engineers and quality assurance experts within Physio-Control would have verified its performance against internal specifications.

4. Adjudication Method for the Test Set

No adjudication method is described, as there isn't a traditional clinical "test set" requiring expert review/adjudication in this 510(k) summary.

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

No MRMC study was done. This type of study is irrelevant for a device modification focused on a battery change, where the core clinical algorithms (defibrillation, ECG, pacing) remain unchanged from a predicate device.

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

The device is not an "algorithm-only" device. It is a medical device, and its algorithms (ECG analysis, etc.) are integrated into the hardware. Its standalone performance for defibrillation, pacing, and ECG monitoring was part of the original predicate device's clearance. This 510(k) does not describe new standalone performance studies.

7. The Type of Ground Truth Used

For the core functionalities (defibrillation waveform, ECG analysis, pacing), the "ground truth" was established during the clearance of the predicate LIFEPAK 20. This would have involved a combination of:

• Engineering validation: Verifying the waveform output, energy delivery, etc.
• Physiological models: For testing rhythm analysis and pacing capabilities.
• Possibly clinical studies: For the original predicate device to demonstrate safety and effectiveness for its intended uses.

For the new battery technology, the "ground truth" would be engineering specifications and safety standards for lithium-ion batteries in medical devices, along with performance targets for operating time.

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of machine learning. The device is not described as an AI/ML device that requires a training set.

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

As there is no mention of a training set, the establishment of its ground truth is not applicable to this submission.

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