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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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