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The Powerheart AED G3 and the Powerheart AED G3 Automatic devices are intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physicianauthorized emergency medical response.

The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Postresuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy (G3) or automatically deliver the charge (G3 Automatic).

When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the device should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

The Powerheart® AED G3 and G3 Automatic are portable, battery operated, automated external defibrillators (AED). After applying the AED's electrodes (pads) to the patient's bare chest, the AED automatically analyzes the patient's electrocardiogram (ECG) and advises the operator to press the button and deliver a shock if needed. The AED uses one button and guides the operator through the rescue using a combination of voice prompts, audible alerts, and visible indicators. For the Powerheart AED G3 Automatic, the AED automatically delivers a shock if needed. The Cardiac Science G3 AEDs may be used in conjunction with an adaptor cable that allows the use of AAMI DF-80 compliant electrodes other than the Cardiac Science brand. This adaptor cable is provided as an accessory to the Cardiac Science AEDs.

1. Acceptance Criteria and Reported Device Performance

The provided document describes a Special 510(k) for modifications to the Powerheart AED G3 and G3 Automatic devices. The acceptance criteria and device performance are primarily evaluated through functional and safety testing to ensure equivalence with predicate devices.

2. Sample Size and Data Provenance

The document states that "Representative samples of the device and adapter cables were tested." However, it does not specify the exact sample size used for the functional and safety testing. The data provenance is derived from internal testing conducted by Cardiac Science Corporation in Bothell, WA. The study is prospective in the sense that the new device and adapter cables were subjected to testing.

3. Number and Qualifications of Experts for Ground Truth

Based on the provided document, there is no mention of external experts or a panel used to establish ground truth for a test set. The evaluation relies on the device meeting pre-defined functional and safety specifications.

4. Adjudication Method

Since there is no mention of a test set requiring expert interpretation or a ground truth established by experts, there is no adjudication method described in the document.

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

An MRMC comparative effectiveness study was not conducted as described in the provided document. The focus of this 510(k) is on demonstrating substantial equivalence of a modified device and accessory through functional and safety testing rather than evaluating reader performance.

6. Standalone (Algorithm Only) Performance Study

The document describes testing of the device and adapter cables as a complete system, including its automatic analysis of ECG and delivery/advising of shock. Therefore, a standalone performance of the algorithm without human-in-the-loop is inherent to its functionality. However, it does not explicitly present a separate "algorithm only" performance study distinct from the overall system's functional testing. The device itself is an automated external defibrillator, meaning its core function is algorithmic analysis and action.

7. Type of Ground Truth Used for Test Set

The "ground truth" for the test set (functional and safety testing) is based on pre-established system, safety, functional, and performance specifications. The device's ability to operate according to these engineering and regulatory standards serves as the ground truth. This is not clinical ground truth (e.g., pathology, outcomes data, or expert consensus on clinical diagnoses).

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI model training in the context of this 510(k) submission. Therefore, no sample size for a training set is provided. The device likely uses established algorithms for ECG analysis that predate this specific submission.

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 not applicable based on the provided information.

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The Powerheart® AED G3 and the Powerheart® AED G3 Automatic devices are intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response.

The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy (G3) or automatically deliver the charge (G3 Automatic).

When a patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the device should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

The Powerheart® AED G3 and G3 Automatic devices are portable, battery-operated, automated external defibrillators (AED) indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. The devices were modified to provide enhanced voice prompts.

The provided document focuses on a 510(k) premarket notification for a modification to the Powerheart® AED G3 and G3 Automatic devices, specifically for enhanced voice prompts. This type of submission generally does not require extensive clinical studies with detailed acceptance criteria and performance metrics in the same way a de novo device submission might. The document asserts "Validation testing relevant to the enhanced voice prompts further supports a substantial equivalence claim," but it does not provide the specifics of that validation testing.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies are not available in the provided text. The document primarily focuses on establishing substantial equivalence to a previously cleared device for a minor modification.

Here's a breakdown of what can be extracted and what is not available:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implicit): Substantial equivalence to the predicate device in intended use, materials, technological characteristics, and performance, particularly concerning the enhanced voice prompts. The document does not provide specific quantitative acceptance criteria (e.g., specific accuracy thresholds for voice prompt understanding).
• Reported Device Performance: The document states that "Validation testing relevant to the enhanced voice prompts further supports a substantial equivalence claim." However, it does not provide any specific quantitative performance metrics from this validation testing (e.g., a percentage of users correctly understanding prompts).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available. The document mentions "Validation testing" but does not specify the sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Available. The document does not describe the establishment of a ground truth for the enhanced voice prompts, nor does it mention any experts involved.

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

• Not Available.

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

• Not Applicable/Not Available. An MRMC study is typically used for diagnostic or image-based AI devices where human readers interpret cases. This device is an AED with enhanced voice prompts, not an AI diagnostic tool. No such study is mentioned or implied.

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

• Not Applicable/Not Available. This device is an Automated External Defibrillator (AED) that interacts with a human user. The voice prompts are inherent to the device's function, not a standalone algorithm in the sense of a standalone diagnostic tool. The performance of the voice prompts would implicitly involve a human listener.

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

• Not Available. Given the nature of "enhanced voice prompts," the "ground truth" would likely relate to the clarity, understandability, and effectiveness of the prompts in guiding user actions, which would be evaluated through user testing rather than clinical ground truths like pathology. However, no details are provided.

8. The sample size for the training set

• Not Applicable/Not Available. This document describes a modification to an existing device, not a new AI model that would require a "training set." The enhanced voice prompts are likely
  pre-recorded or synthesized speech, where the "training" would have occurred during their development, not during a separate study described in this submission.

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

• Not Applicable/Not Available. (See point 8).

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