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Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. .

The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation.

The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25kg (55lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.

ECG Monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring

The LIFPAK 1000 defibrillator is a semi-automatic defibrillator with optional manual mode and ECG display. It is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. There are 3 modes of operation for the LIFEPAK 1000 defibrillator: AED mode (automated external defibrillation), manual mode (operator ECG interpretation, operator control of charge and shock functions), and ECG mode (ECG display allows for rhythm and heart rate monitoring). The currently marketed LIFEPAK 1000 defibrillator is powered by a non-rechargeable lithium-manganese battery.

The proposed LIFEPAK 1000 defibrillator has the same features and functions as the predicate LIFEPAK 1000 defibrillator with an additional battery option - a rechargeable lithium-ion battery.

The provided document is a 510(k) summary for the LIFEPAK 1000 defibrillator, seeking substantial equivalence to a previously cleared device. The key information is that the only change is the addition of a rechargeable lithium-ion battery option. The document explicitly states that the "defibrillation waveform, ECG analysis system, and monitoring and defibrillation features of the proposed LIFEPAK 1000 defibrillator are unchanged from the previously cleared LIFEPAK 1000 defibrillator."

This directly implies that no new clinical studies were conducted to prove device performance or meet acceptance criteria related to its core defibrillation or ECG analysis functions. The substantial equivalence is based on the fact that these critical functional components remain identical to the predicate device, and new testing was likely focused on the safety and performance of the new battery option (though specifics of this testing are not detailed in this summary).

Therefore, this document does not contain the information required to answer most of your questions about acceptance criteria and associated studies for the device's functional performance.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document states that the defibrillation waveform and ECG analysis system are unchanged from the predicate device. It does not provide acceptance criteria or performance metrics for these functions for the current submission, nor does it refer to specific studies done for this submission.

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

• Cannot be provided. No clinical performance test set details are presented for the updated device in this submission.

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

• Cannot be provided. No clinical performance test set details are presented.

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

• Cannot be provided. No clinical performance test set details are presented.

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:

• Cannot be provided. This device is an external defibrillator, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or relevant here.

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

• Cannot be provided. While defibrillators have algorithms for AED mode, no specifics of standalone algorithm performance studies are described in this summary for the updated device. The document emphasizes the unchanged nature of the ECG analysis system from the predicate.

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

• Cannot be provided. No specific studies requiring ground truth establishment are detailed for this submission.

8. The sample size for the training set:

• Cannot be provided. No training set for an algorithm is discussed in this submission.

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

• Cannot be provided. No training set is discussed.

Summary of available information:

• Device: LIFEPAK 1000 defibrillator
• Change: Addition of a rechargeable lithium-ion battery option.
• Justification: Substantial equivalence based on the core functional components (defibrillation waveform, ECG analysis system, monitoring and defibrillation features) being unchanged from the predicate device (K042404).
• Conclusion: The 510(k) notification argues that due to the only change being a battery option and the core functions remaining identical to a previously cleared device, the updated device is substantially equivalent to the predicate, implying that specific clinical performance studies for defibrillation efficacy or ECG analysis were not required for this particular submission.

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