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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 patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. It is not intended for use on children less than eight years of age, per Att A quidelines .

The Biphasic LIFEPAK 500 Automated External Defibrillator (AED) is a portable battery powered device which applies a brief, high energy pulse of electricity to the heart via defibrillation electrodes on the chest. A software algorithm analyzes the patients electrocardiogram (ECG) and informs the operator whether it detects a shockable rhythm. The operator can then press the shock button to deliver energy after confirming that the patient is unconscious, pulseless and apneic.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medtronic Physio-Control Corporation Biphasic LIFEPAK® 500 Automated External Defibrillator:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format, nor does it provide a direct table of reported device performance against such criteria. Instead, it states that the device is "substantially equivalent" to predicate devices and complies with relevant AAMI standards.

The primary performance metric mentioned is the "efficacy of the biphasic truncated exponential waveform."

Study Details from the Provided Text:

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

   • Sample Size: Not explicitly stated in the provided text. The text mentions a "multisite clinical study" but does not give the number of patients or events.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "multisite clinical," suggesting it involved multiple locations, but specific geographic regions are not mentioned. It is implied to be prospective since it's a clinical study to demonstrate efficacy for a new waveform.

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

   • This information is not provided in the given text.

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

   • This information is not provided in the given text. The description focuses on the device's waveform efficacy rather than a diagnostic algorithm requiring expert adjudication of outputs.

4. 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 background for MRMC study: The device is an Automated External Defibrillator (AED), which relies on an algorithm to analyze the patient's ECG and inform the operator. It's not a diagnostic imaging device where human readers interpret results aided by AI. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable in this context and was not done according to the provided information.

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

   • Yes, in essence. The core of the device is its "software algorithm [that] analyzes the patients electrocardiogram (ECG) and informs the operator whether it detects a shockable rhythm." The "efficacy of the biphasic truncated exponential waveform" was demonstrated in a clinical study. This efficacy relates to the device's ability to successfully defibrillate, which is a direct outcome of its core function (waveform delivery) after the algorithm identifies the rhythm. While a human delivers the shock, the critical step of rhythm analysis and energy delivery (waveform) is automated; therefore, the clinical study essentially evaluates the standalone performance of the device's ability to treat shockable rhythms.

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

   • The ground truth for evaluating AEDs typically involves clinical outcomes data (e.g., successful termination of ventricular fibrillation/tachycardia, return of spontaneous circulation, survival to discharge) as observed in a clinical setting. The statement "The efficacy of the biphasic truncated exponential waveform was demonstrated in a multisite clinical study" strongly implies the use of such outcomes data as ground truth. The algorithm's accuracy in identifying shockable rhythms would also be a critical part of the ground truth, likely established by comparison to physician-interpreted ECGs or established rhythm classifications.

7. The sample size for the training set:

   • This information is not provided in the given text. The summary focuses on the substantial equivalence and clinical validation of the new waveform, not the internal development or training of the ECG analysis algorithm.

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

   • This information is not provided in the given text. Similarly to the training set sample size, details about the algorithm's development or training ground truth are outside the scope of this 510(k) summary.

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The LIFEPAK 500 Automated External Defibrillator may be used in the hospital or pre-hospital setting by authorized personnel to terminate certain potentially fatal cardiac arrhythmias.

The LIFEPAK 500 Automated External Defibrillator (AED) is a portable battery powered device which applies a brief, high energy pulse of electricity to the heart via defibrillation electrodes on the chest. A software algorithm analyzes the patients electrocardiogram (BCG) and informs the operator whether it detects a shockable rhythm. The operator can then press the shock button to deliver energy after confirming that the patient is unconscious, pulseless and apneic.

The provided text, a 510(k) summary for the Physio-Control LIFEPAK 500 Automated External Defibrillator (AED), focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting the acceptance criteria and a detailed study proving the device meets those criteria from an AI/algorithm performance perspective.

Here's an attempt to extract and infer the requested information based on the provided text, recognizing that some details might be missing or require interpretation:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the nature of an AED and the AAMI standards cited, the core acceptance criteria for the arrhythmia detection algorithm would be related to its ability to correctly identify shockable rhythms (sensitivity) and non-shockable rhythms (specificity). The document states the device uses the same arrhythmia detection algorithm that is used in the LIFEPAK 300 AED, implying that the performance met the criteria established for the predicate device. However, specific numerical thresholds for sensitivity and specificity are not explicitly stated in this excerpt.

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

The document does not explicitly state the sample size (number of ECG rhythms/cases) used for the rhythm detection algorithm's test set. It also does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the excerpt. For an AED's rhythm analysis, ground truth for a test set would typically involve expert cardiologists or electrophysiologists labeling ECGs.

4. Adjudication Method for the Test Set

This information is not provided in the excerpt. Common adjudication methods include 2+1 (two agree, one breaks ties) or 3+1 (three agree, one breaks ties).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This document describes a device submission for an AED with an automatic external defibrillator function. The focus is on the algorithm's performance in detecting shockable rhythms, not on assisting human readers in interpreting ECGs. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable and not mentioned. The device's primary function is standalone rhythm analysis followed by operator action.

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

Yes, a standalone performance evaluation of the algorithm's rhythm detection capabilities was implicitly done. The statement "A software algorithm analyzes the patients electrocardiogram (BCG) and informs the operator whether it detects a shockable rhythm" and "rhythm detector function" tests indicate that the algorithm's performance in analyzing ECGs independently was assessed. The 510(k) process for devices like AEDs heavily relies on the standalone accuracy and reliability of their algorithms.

7. The Type of Ground Truth Used

While not explicitly stated, for an AED's rhythm detection algorithm, the most appropriate and likely ground truth would be expert consensus by cardiologists or electrophysiologists based on detailed ECG analysis and potentially clinical correlation from the patients' records. Pathology or outcomes data would be less direct for the rhythm detection algorithm's ground truth, though overall device effectiveness would be linked to outcomes.

8. The Sample Size for the Training Set

This information is not provided in the excerpt.

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

This information is not provided in the excerpt. Similar to the test set, it would typically involve expert review and labeling of ECG data.

In summary of the limitations of the provided text:

The 510(k) summary is designed to demonstrate substantial equivalence, not to detail the full performance study of the algorithm's development and validation in the way a more comprehensive study publication might. It confirms that the device meets relevant standards and that the algorithm is the same as a previously cleared device, implying its performance has been sufficiently validated. Specific metrics for the algorithm's sensitivity and specificity, along with details about the test/training data, expert adjudication, and ground truth establishment, are not included in this high-level summary.

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