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To power the functions of various devices for which batteries or battery packs are configured.

Since non-rechargeable batteries and battery packs are "device specific" and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, or install these devices.

This battery is shipped only to customers who request a replacement battery for a PhysioControl LP500 AED (OEM P/N: 3005380-026, 11141-00013) or to replace a competitor's replacement battery for the same AED.

Biomedical equipment service professionals therefore know that the intended use is as a replacement battery.

Non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment. These devices provide a means of supplying electrical power through chemical reaction. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current used by the device into which they are installed. The performance and life span of these batteries depends on operating conditions of temperature, current drain, and the discharge method. These parameters are taken into account in designing such batteries. The goal is to develop battery packs that maintain capacity for as high and as long as possible under a specified range of environmental conditions.

This document is a 510(k) summary for a replacement battery pack, not a comparative effectiveness study or a standalone AI algorithm performance study. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design for proving equivalence, and information about AI model testing.

Here's a breakdown of what can be gleaned from the provided text, and what cannot:

What can be extracted (though not in the format requested as it's not a performance study):

• Device: R & D Battery Pack P/N 6019
• Intended Use: To power functions of various devices, specifically as a replacement battery for a PhysioControl LP500 AED.
• Predicate Device: AMCO Battery Pack P/N 5L500, also used in the PhysioControl LP500 AED.
• Basis of Equivalence: The document states "The design components and functionality of the R & D Batteries Inc. P/N 6019 battery pack is identical to the predicate device. Cell chemistry and type are identical. Sealed (Vented) Lithium / Sulphur Dioxide (Li/SO2)."

Information that is NOT available in this document:

Since this is a 510(k) premarket notification for a battery pack, not a medical device driven by an algorithm or intended for diagnostic/therapeutic functions requiring complex performance metrics, the following information is not applicable or not provided:

1. A table of acceptance criteria and the reported device performance: While there would be internal specifications and performance targets for the battery, this document does not present them as "acceptance criteria" for a primary efficacy or diagnostic study. The equivalence is based on being "identical" to a predicate, not necessarily meeting a specific set of clinical performance cutoffs.
2. Sample size used for the test set and the data provenance: Not applicable. Equivalence is primarily demonstrated through design and material identity, along with bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no ground truth in the context of expert consensus for a battery's performance in this type of submission.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a battery, not an algorithm.
7. The type of ground truth used: Not applicable in the context of clinical outcomes or expert consensus. For a battery, "ground truth" relates to its physical and electrical properties meeting specifications.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable.

What performance/safety testing was done (as per the document):

• Type of Study: Bench tests
• Equipment used: Medtronic's/PhysioControl LP500 AED and a NETECH Model Delta 2200 Defibrillator Analyzer.
• Tests conducted:
  • Life Cycle
  • Temperature
  • Mechanical & Electrical Component Integrity
• Reference: The document refers to "013 Performance Testing for procedures and results," which is an internal document not provided here.

In summary, this document is a regulatory submission demonstrating substantial equivalence of a replacement battery pack to an existing one, based on identical design, materials, and bench testing, rather than a clinical study evaluating diagnostic or therapeutic efficacy of a complex medical device or AI system.

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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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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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