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The Powerheart® AED G3 is 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.

When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the Powerheart® AED G3 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 is a portable, battery-operated, semi-automatic, low power DC defibrillator. The device is designed to diagnose and monitor the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy. The Powerheart® AED device in this submission is identical to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901 and K982710. The reason for this premarket notification is to introduce minor modifications to the device and upgrade software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardiac Science Powerheart® AED G3:

Overview:
It's important to note that this 510(k) submission (K031987) is for minor modifications and a software upgrade to an already cleared device. The submission explicitly states: "The Powerheart® AED device in this submission is identical to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901 and K982710. The reason for this premarket notification is to introduce minor modifications to the device and upgrade software." and "The device modifications do not raise any new issues of safety or effectiveness."

Because of this, the submission doesn't detail a comprehensive new study to establish initial performance metrics but rather to demonstrate that the modifications did not negatively impact the device's existing established performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., Sensitivity > X%, Specificity > Y%). Instead, the "acceptance criteria" appear to be that the modified device performs as intended and that the modifications had no affect on the safety or effectiveness of the device.

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

The document does not specify a distinct "test set" with a defined sample size for clinical or algorithm performance evaluation in this submission. The testing conducted was described as "performance hardware and software evaluations."

• Sample Size for Test Set: Not explicitly stated as a number of patient cases or ECGs. The text refers to "performance hardware and software evaluations," which are typically done on the device itself through engineering and verification methods rather than biological data sets.
• Data Provenance: Not applicable/not specified for this type of evaluation. The "testing" appears to be internal engineering and verification, not clinical data evaluation for algorithm performance on patient data.

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

Not applicable. This submission focuses on hardware and software verification of minor changes, not the establishment of ground truth for a diagnostic algorithm using expert review of clinical data.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was not a study involving expert adjudication of a test set of clinical data.

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. This document does not describe an MRMC comparative effectiveness study. The device is an Automatic External Defibrillator (AED), which is largely an automated system designed for lay rescuers or personnel trained in its operation, not for human readers to interpret complex images or data with AI assistance. Its primary function is automated rhythm analysis and shock advisory.

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

The performance testing described ("performance hardware and software evaluations") would implicitly cover the standalone performance of the algorithm within the device. The "algorithm" for an AED is its ability to accurately detect shockable rhythms (like Ventricular Fibrillation or Ventricular Tachycardia) and differentiate them from non-shockable rhythms. While the document doesn't provide specific standalone sensitivity and specificity numbers, the statement "The Powerheart® AED G3 passed all software and hardware tests and was found to perform as intended" implies that its rhythm analysis algorithm (the core of a standalone AED) met its specifications.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not detail the type of ground truth used for the algorithm's rhythm analysis performance. For AEDs, the ground truth for rhythm analysis (e.g., shockable vs. non-shockable) is typically established by expert cardiologists or electrophysiologists independently reviewing ECG recordings and classifying them. However, for this specific 510(k) (minor changes), the ground truth for the original algorithm's performance would have been established in prior submissions (K022929, K011901, K982710). This submission primarily focuses on demonstrating that the minor modifications did not degrade that previously established performance.

8. The Sample Size for the Training Set

Not applicable/not specified for this submission. The training set for the original AED algorithm would have been part of the initial development and validation process for the predicate devices. This 510(k) is about modifications to an existing device, not the development of a new algorithm requiring a new training set.

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

Not applicable/not specified. Similar to the test set, the ground truth for the training set (if the algorithm used machine learning, which was less common for AEDs in 2003, but still relevant) would have been established during the development of the original predicate devices, likely through expert review of ECG waveforms.

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