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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 25 kg (55 lbs) 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 LIFEPAK 1000 defibrillator is a semi-automatic defibrillator with manual mode and ECG mode available as options. The manual mode allows a caregiver skilled in rhythm recognition to switch to manual mode and treat the patient without relying on the automated analysis feature and without connecting a separate defibrillator. Features and options of the LIFEPAK 1000 defibrillator include: ECG rhythm and heart rate monitoring using defibrillation electrodes or using an ECG cable with monitoring electrodes, data transmission via serial infrared link, power via non-rechargeable lithium manganese battery, and configurable voice prompts.

The provided text does not contain detailed acceptance criteria or a study that explicitly proves the device meets specific performance metrics. The submission focuses on substantial equivalence to previously cleared devices (Medtronic LIFEPAK 500 AED and Philips HeartStart FR2+ Defibrillator) and conformance to general electrical safety, electromagnetic compatibility, and defibrillator standards.

Therefore, many of the requested sections (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) cannot be extracted from this document, as this type of information is typically found in detailed performance studies or clinical trials, which are not provided here.

However, based on the excerpt, here's what can be gathered:

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

The document does not specify quantitative acceptance criteria or a detailed performance table. It broadly states: "The information in this 510(k) demonstrates that the LIFEPAK 1000 defibrillator is substantially equivalent to legally marketed predicate devices with respect to safety, effectiveness, and performance." This implies that the performance is considered acceptable if it is comparable to the predicate devices.

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

This information is not provided in the document.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

This information is not provided in the document. The device is a defibrillator, which uses automated analysis, and the document focuses on its standalone performance characteristics and equivalence, not a reader study.

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

The document states, "The manual mode allows a caregiver skilled in rhythm recognition to switch to manual mode and treat the patient without relying on the automated analysis feature and without connecting a separate defibrillator." This implies that the device has an "automated analysis feature" (algorithm only) that assists in defibrillation decisions. While specific standalone performance metrics are not listed, the reliance on an automated analysis feature suggests a standalone assessment would have been part of the underlying data submitted to the FDA, but it is not detailed in this summary.

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

Given that the device performs "automated analysis" for rhythm recognition in AED mode, the ground truth for such analysis would typically be established based on:

• Expert Consensus (ECG Interpretation): For rhythm recognition algorithms, the ground truth is typically derived from review of ECG waveforms by trained cardiologists or other experts.
• Clinical Outcomes (Defibrillation Effectiveness): For defibrillation itself, the ground truth relates to successful termination of arrhythmias, which would be observed clinically.

However, the specific type of ground truth used is not explicitly stated in this document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of available information regarding performance:

The 510(k) submission for the Medtronic LIFEPAK 1000 Defibrillator primarily relies on the concept of substantial equivalence to previously cleared devices (Medtronic LIFEPAK 500 AED and Philips HeartStart FR2+ Defibrillator).

The document mentions that the submission included "documentation related to the conformance of the LIFEPAK 1000 defibrillator to electrical safety, electromagnetic compatibility, and defibrillator standards." While these are critical aspects of performance and safety, specific quantitative acceptance criteria or detailed study results for these conformance tests are not presented in this summary. The general statement is that the device demonstrates "safety, effectiveness, and performance" consistent with its predicate devices.

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