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Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by: Unconsciousness and Absence of normal breathing and Absence of a pulse or signs of circulation. When a victim is less than 8 years of age, or weighs less thank 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

The device is a lightweight, portable, battery-powered semi-automatic external defibrillator that uses voice prompts and visual icons to guide a user through a cardiac arrest rescue. The device utilized the ZOLL Rectilinear Bi-Phasic defibrillation waveform. The device is designed to be used by trained responders for the treatment of cardiac arrest. When connected with ZOLL AED Plus defibrillation electrodes to a patient, the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a shockable rhythm, the device charges the capacitor, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. If the device detects a non-shockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that mesures the depth of CPR compressions. This information is used by the device to provide feedback to the user and encourage the user to administer CPR in compliance with the American Heart Association (AHA) Guidelines. The device provides feedback in the form of a metronome (to encourage the proper CPR frequency of 100 compressions per minute) and a visual depth indicator on the display (to encourage the recommended compression depth).

Here's an analysis of the acceptance criteria and study information for the ZOLL AED Plus with the 2010 AHA Guidelines Software Update, based on the provided text.

Based on the provided text, the device in question is a software update for an existing Automatic External Defibrillator (AED), the ZOLL AED Plus. The update primarily changes the CPR compression depth feedback to align with the 2010 AHA Guidelines.

It is critical to understand that this submission is a 510(k) for a software update to an already cleared device, not a new device requiring extensive clinical trials for a de novo clearance. This means the performance testing primarily focuses on demonstrating that the updated software maintains the safety and effectiveness of the predicate device and meets the new CPR depth recommendations.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format that would typically be seen for a new device's diagnostic performance (e.g., sensitivity, specificity for a diagnostic algorithm). Instead, the "acceptance criteria" implicitly relate to adhering to the new AHA guidelines and demonstrating substantial equivalence to the predicate device.

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The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, or advanced life support, or other physician authorized emergency medical response to defibrillate victims of cardiac arrest. Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by:

• Unconsciousness and .
• Absence of normal breathing and ●
• Absence of a pulse or signs of circulation .

When a victim is a child or infant less than 8 years of age, or less than 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

The ZOLL AED Plus is a lightweight, portable, battery-powered semi-automatic external defibrillator that utilizes the ZOLL Rectilinear Bi-Phasic defibrillation waveform to guide a user through a cardiac arrest rescue. The device is designed to be used by trained emergency responders for the treatment of cardiac arrest.

When connected with ZOLL AED Plus defibrillation electrodes to a patient, the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a shockable rhythm, the device charges the capacitor, enables the "Shock Button", and issues the warning "Don't Touch Patient". The user can then press the treatment button to deliver defibrillation therapy to the patient. If the patient is not in a shockable rhythm, CPR may be advised and administered after automatically repeated analyses of the patient's heart rhythm.

The ZOLL AED Plus is lightweight. It can easily be transported to any rescue site. It is rugged and ready to use at a moment's notice. The device automatically performes a periodic self-test and continually indicates its state of readiness to the user.

When the ZOLL AED Plus is used in conjunction with the ZOLL AED Plus Pediatric Electrodes, the device can be used on patients less than 8 years of age. Labeling and packaging of the electrodes is designed to promote a clear visual distinction between adult and pediatric electrodes.

Here's an analysis of the provided text regarding the ZOLL AED Plus (V5.32 Software Release) and its FDA 510(k) clearance (K091561), focusing on acceptance criteria and study details.

It's important to note that the provided 510(k) summary does not contain detailed performance criteria or a standalone study proving the device meets specific acceptance criteria in the way a typical AI/software device submission would today. This 510(k) clearance is from 2010 for a software update to an existing AED, and the focus is on demonstrating "substantial equivalence" to the previously cleared version, rather than setting and meeting new, quantitative performance objectives.

However, I will extract the information available and highlight where specific details you requested are not present in the document.

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated. The document refers to "extensive performance testing" but does not provide details on the sample size of cases or patients used for this testing.
   • Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data, nor whether the data was retrospective or prospective. Given the nature of AED testing, it likely involves simulated cardiac rhythms and possibly animal or human subject testing under controlled conditions, but no specifics are provided.

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

   • Number of Experts: Not applicable/Not mentioned. For an AED's rhythm analysis, ground truth is typically established based on well-defined ECG characteristics and established medical standards for shockable vs. non-shockable rhythms, rather than expert consensus on individual cases. The document does not describe human experts establishing ground truth for a test set in the context of rhythm analysis.

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

   • Adjudication Method: Not applicable/Not mentioned. As the ground truth is likely based on objective ECG criteria and a "gold standard" for rhythm classification in AEDs, a human adjudication process for individual cases (like 2+1 or 3+1 for imaging datasets) is not typically performed or described for this type of device.

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:

   • MRMC Study: No. This device is an automated external defibrillator; its primary function is to analyze ECG and deliver shocks independently, guiding a human user rather than assisting a human "reader" in making a diagnostic decision in the same way an AI for medical imaging would. The "human readers" in this context (trained emergency responders) are following explicit device instructions (e.g., "Press Shock Button") rather than interpreting data with AI assistance. Therefore, an MRMC study comparing human reader performance with and without this AI (algorithm) assistance is not relevant to this device's function and was not performed or described.

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

   • Standalone Performance: Yes, implicitly. The core function of the AED, specifically its rhythm analysis (detecting "shockable" or "non-shockable" rhythms), is a standalone algorithm operation. The document states: "the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or non-shockable." This analysis is performed by the algorithm (software version 5.32) without human intervention in the analysis process itself. The human-in-the-loop aspect comes from the user pressing the shock button after the device has made its determination and verbalized instructions. However, no specific performance metrics (e.g., sensitivity, specificity for shockable rhythm detection) are provided for this standalone algorithm.

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

   • Type of Ground Truth: Implicitly, established medical standards and objective ECG interpretations. For rhythm analysis in AEDs, the ground truth for what constitutes a "shockable" rhythm (e.g., Ventricular Fibrillation, Pulseless Ventricular Tachycardia) is based on universally accepted electrocardiographic criteria and international resuscitation guidelines. This is not typically "expert consensus" on specific cases but rather adherence to predefined diagnostic criteria.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable/Not mentioned. This document describes a software update (V5.32) to an existing AED for "substantial equivalence." While the original development of an AED's rhythm analysis algorithm would have involved training data, this specific 510(k) does not mention a training set or its size. The focus is on demonstrating that the updated software performs equivalently and safely to the predicate device, not on validating a newly developed AI model from scratch.

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

   • Ground Truth for Training Set: Not applicable/Not mentioned. Similar to point 7, this information is typically relevant for initial algorithm development. For a software update demonstrating substantial equivalence, the specific details of the original training set ground truth establishment are not typically re-evaluated or documented in the 510(k) summary. It would have been based on established ECG classification standards and medical guidelines.

Summary of Limitations in the Document:

The provided 510(k) summary for the ZOLL AED Plus (V5.32) is primarily focused on demonstrating "substantial equivalence" to a previously cleared predicate device (K033474 from 2005) following a software update. As such, it highlights functional and safety equivalence rather than presenting new, detailed performance studies with quantitative acceptance criteria, extensive test sets, or ground truth establishment methods typical of a novel AI device submission. The FDA clearance is based on the assertion that the updated device performs "as well as" and meets the "functional requirements and performance specifications" of the legally marketed predicate device, without detailing those specific metrics for the updated device in this summary.

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Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by:

• Unconsciousness and .
• Absence of normal breathing and .
• Absence of a pulse or signs of circulation. .

When a victim is less than 8 years of age, or weighs less than 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response to defibrillate victims of cardiac arrest.

The ZOLL AED Plus is a lightweight, portable, battery powered semi-automatic external defibrillator that uses voice prompts and visual icons to quide a user through a cardiac The device utilizes the ZOLL Rectilinear Bi-Phasic defibrillation arrest rescue. waveform. The device is designed to be used by trained emergency responders for the treatment of cardiac arrest.

When connected with ZOLL AED Plus defibrillation electrodes to a patient, the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or not shockable. If the device detects a shockable rhythm, the device charges the capacitor, enables the treatment button and issues the audio warning "Don't Touch Patient, Press Treatment Button". The user can then press the treatment button to deliver defibrillation therapy to the patient. If the patient is not responsive to treatment, additional shocks may be advised and administered after automatically repeated analyses of the patient's heart rhythm.

The ZOLL AED Plus is lightweight. It can easily be transported to any rescue site. It is designed to hang on the wall in an area where it is easily accessible and ready to use at a moment's notice. The device automatically performs a periodic self-test and continually indicates its state of readiness to the user.

When the ZOLL AED Plus is used in conjunction with the ZOLL AED Plus Pediatric Electrodes the device can be used on patients less than 8 years of age. Labeling and packaging of the electrodes is designed to promote a clear visual distinction between adult and pediatric electrodes.

The ZOLL AED Plus device is a semi-automatic external defibrillator designed for use by trained emergency responders. The provided documentation primarily addresses substantial equivalence for market clearance rather than detailed performance reporting from specific clinical studies to establish acceptance criteria. Therefore, much of the requested information about acceptance criteria and study particulars for device performance as typically understood for AI/algorithm-driven devices (accuracy, sensitivity, specificity, etc.) is not explicitly available in the provided text.

However, based on the information provided, here's a breakdown of what can be extracted and what is not explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on a declaration of substantial equivalence based on safety and functional performance meeting established standards, rather than providing specific numerical performance metrics (like sensitivity/specificity for rhythm classification against a ground truth).

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

• Sample Size: Not explicitly stated for any specific test set, including the "pediatric database" used for rhythm classification.
• Data Provenance: Not specified (e.g., country of origin). The terms "retrospective" or "prospective" are not used.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The document mentions "rhythm classification algorithm performance testing on a pediatric database" but does not describe how the ground truth for that database was established or by whom.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not discussed or reported in the provided text. The document focuses on the device's functional and safety performance relative to standards and its predicate device. This type of study (human readers with/without AI assistance) is typically relevant for interpretative AI devices, which this AED system is not described as in the sense of directly assisting human interpretation of complex medical images or data beyond basic rhythm analysis in an emergency.

6. Standalone (Algorithm Only) Performance

A standalone performance evaluation was implied for the "rhythm classification algorithm performance testing on a pediatric database." However, specific metrics (e.g., sensitivity, specificity, PPV, NPV) from this standalone performance are not reported in the document. The document states that final testing included "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications," but the details of these are not provided.

7. Type of Ground Truth Used

The type of ground truth used for the "pediatric database" rhythm classification algorithm testing is not explicitly stated. For ECG rhythm analysis, ground truth is typically established by expert cardiologists reviewing the ECG tracings. Without explicit mention, it's assumed to be expert consensus, but this is not confirmed.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. The focus is on the device's final performance and adherence to standards for substantial equivalence.

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

Since a training set is not mentioned, the method for establishing its ground truth is also not provided.

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