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The LIFEPAK 500 AED is intended for use on patients in cardiac arrest. It is intended for use in hospital and in out-of-hospital environments.

The LIFEPAK 500 AED is intended for use by personnel who are authorized by a medical director and have, at a minimum, the following skills and training:

• CPR training
• AED training equivalent to that recommended by the American Heart Association
• Training in the use of the LIFEPAK 500 AED

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. With Infant/Child Reduced Energy Defibrillation Electrodes, the specially configured biphasic LIFEPAK 500 AED may be used on children up to 8 years old or 25kg (55 lb).

The LIFEPAK 500 automated external defibrillator is a small, portable, battery operated device intended for treatment of cardiac arrest. The device uses a patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present. The LIFEPAK 500 AED will inform the operator if it detects a shockable rhythm and the operator can press the shock button to deliver energy. The energy is delivered via disposable defibrillation electrodes applied to the chest.

The provided 510(k) summary for the Medtronic biphasic LIFEPAK 500 Automated External Defibrillator (AED) focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the traditional sense of a performance study with numerical endpoints.

The submission states: "The features and functions of the modified biphasic LIFEPAK 500 AED are the readies and railer [likely a typo, suggesting 'the same as and similar'] to the previously cleared Medtronic LIFEPAK 500 AED, Substantially Squarants K955854 (11/4/96), K983393 (05/05/99), K012428 (09/28/01), 310(k) hambers 119690); and the Philips Medical Systems Heartstream Heartstart FR2+ AED, 510(k) number K013425 (01/14/2002)." It also mentions, "Defibrillation technology and functionality are unchanged from the previously Declorination technology and Imerely and 500 software has been modified to allow the medical director or physician greater control over CPR settings."

Therefore, the "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate devices, and the "study" is a demonstration of substantial equivalence through design control activities and comparison to those predicates. The document does not provide quantitative performance metrics, sample sizes for a test set, ground truth experts, or details of a standalone or MRMC study.

However, based on the information provided, we can infer some aspects and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The submission relies on substantial equivalence to predicate devices, which would have undergone their own testing. There is no new, independent clinical or performance test set described for this modified device.
• Data Provenance: Not specified for new testing. The reference devices K955854, K983393, K012428, and K013425 would have generated their own clinical data.

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

• Not applicable as no independent test set or ground truth establishment process is described for this specific 510(k). The regulatory review of the predicate devices would have involved expert review.

4. Adjudication method for the test set

• Not applicable as no independent test set or adjudication process is described for this specific 510(k).

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 MRMC study is mentioned. This device is an AED that uses an algorithm to determine shockable rhythms, not an AI-assisted diagnostic tool for human readers in the context of MRMC studies.

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

• The device inherently operates as a "standalone" algorithm in its primary function of ECG analysis. The human operator presses the shock button after the device informs them a shockable rhythm is detected. However, the document does not describe a formal "standalone performance study" with specific metrics (e.g., sensitivity, specificity for rhythm analysis) for this specific modified device. It relies on the performance of the predicate devices. The algorithm's performance for rhythm analysis would have been established for the original LIFEPAK 500.

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

• Not specified for this 510(k). For AEDs, ground truth for rhythm analysis typically involves expert review of ECGs, often verified against clinical outcomes where appropriate.

8. The sample size for the training set

• Not specified. The software algorithm is "patented" and "modified to allow the medical director or physician greater control over CPR settings," suggesting the core rhythm detection algorithm was developed and validated previously with an unspecified training set.

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

• Not specified. This would have been established during the development of the original LIFEPAK 500 algorithm. Typically, this involves a large dataset of ECGs with rhythm classifications established by expert cardiologists or electrophysiologists.

Summary of the "Study" provided in the 510(k):

The "study" for this 510(k) is a demonstration of substantial equivalence rather than a traditional performance study with new raw data. The core of the argument is that:

• The device's intended use and indications for use are the same as predicate devices.
• The fundamental defibrillation technology and functionality remain unchanged from previously cleared versions of the LIFEPAK 500.
• The software modification is related to CPR settings, not the core rhythm analysis or energy delivery, implying no impact on primary safety or effectiveness.
• The submission includes "a summary of design control activities and a declaration of conformity to design controls," which is the regulatory mechanism used to demonstrate that the modified device's changes do not introduce new safety or effectiveness concerns compared to the predicates.

Therefore, the acceptance criteria are met by virtue of the modified device being substantially equivalent to legally marketed predicate devices which have already met their respective acceptance criteria for safety and effectiveness.

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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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