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The Powerheart® AED G3 family of devices 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 ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will change 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.

Additional information exclusive to the Powerheart® AED G3 Pro, Model 9300P:

At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with Model 5111 ECG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and ECG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro ECG Patient Cable, the G3Pro evaluates the patient's ECG and disables its shock capability.

The Powerheart® AED G3 family of devices (Model numbers 9300A/E, model numbers 9390A/E, and model number 9300P) are portable, battery operated, automatic or semi-automatic, automated external defibrillators (AED). After applying the AED electrodes (pads) to the patient's bare chest, the AED automatically analyzes the patient's electrocardiogram (EGG) 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. For the Powerheart® AED G3 Semi-automatic, the AED uses one button and advises the operator to press the button and deliver a shock if needed.

The Powerheart® AED G3 family of devices includes a periodic automatic self-test feature. The focus of this submission is a software modification to enhance the detection capability of the device self-test feature.

The provided text describes a 510(k) premarket notification for a software modification to existing Powerheart® AED G3 devices. The core of this submission is about enhancing the detection capability of the device's self-test feature, not about a new clinical algorithm for patient diagnosis or treatment. This type of submission typically focuses on functional and performance testing related to the software change rather than a comprehensive clinical study to prove efficacy in an AI context.

Therefore, many of the requested elements for an AI/device performance study (like MRMC studies, sample sizes for training/test sets, expert qualifications, etc.) are not applicable or not provided in this document as it pertains to a software change for a self-test feature in an AED. The document essentially states that the new software has been verified and validated to ensure continued safety and effectiveness, and that it is substantially equivalent to the previously cleared predicate devices.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and where gaps exist:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a table format with specific metrics for the software modification. Instead, it concludes that "software verification and validation testing has been successfully completed for all models of the modified Powerheart® AED G3 family of devices to demonstrate appropriate functional and performance characteristics."

The implicit acceptance criterion for this 510(k) submission is that the modified software maintains the safety and effectiveness of the device and does not raise new questions of safety or effectiveness compared to the predicate device. The "reported device performance" is summarized as "appropriate functional and performance characteristics" being demonstrated.

Given that this is a 510(k) for a software enhancement to a self-test feature, quantitative clinical performance metrics (like sensitivity, specificity for detecting cardiac events) are not the focus of this particular submission. The focus is on the self-test's capability to detect issues.

Study Details

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

   • Acceptance Criteria: Implicitly, the software modification must maintain the safety and effectiveness of the device, as demonstrated through successful verification and validation testing, and ensure no new questions of safety or effectiveness are raised compared to the predicate device.
   • Reported Device Performance: "Software verification and validation testing has been successfully completed for all models of the modified Powerheart® AED G3 family of devices to demonstrate appropriate functional and performance characteristics."

2. Sample sizes used for the test set and the data provenance:

   • Not explicitly stated in the provided text. The document mentions "software verification and validation testing" but does not detail the specific test cases, sample sizes, or the origin of any data used for these tests. For a self-test software change, this would likely involve internal testing data rather than patient data from specific countries.

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

   • Not applicable/Not stated. This submission focuses on a software modification for a self-test mechanism, not on a diagnostic algorithm requiring expert-established ground truth from medical images or physiological signals.

4. Adjudication method for the test set:

   • Not applicable/Not stated. As above, no clinical diagnostic "ground truth" relevant to human adjudication appears to be established for this software modification.

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, an MRMC study was not done or reported. This type of study is relevant for AI-powered diagnostic or assistive tools where human performance can be measured and compared with and without AI assistance. This submission describes a modification to a device's self-test feature, which does not involve human readers in an diagnostic capacity in conjunction with an AI.

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

   • Yes (inferred), in the context of the self-test. The core of this submission is a "software modification to enhance the detection capability of the device self-test feature." This implies that the algorithm for the self-test itself operates in a standalone manner to identify potential device malfunctions. The performance of this specific software component would have been evaluated directly. Details on this evaluation are not available beyond the statement of successful completion.

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

   • Not explicitly stated. For a self-test feature, the "ground truth" would likely be derived from engineering specifications and known failure modes, simulated faulty conditions, or controlled test environments designed to verify the self-test's ability to detect predetermined internal issues. It is not a clinical ground truth like pathology or expert consensus on patient diagnosis.

8. The sample size for the training set:

   • Not applicable/Not stated. This submission describes a software modification to an existing device's self-test, not the development of a new AI algorithm that typically requires a large training set from medical data. If any "training" occurred, it would be in the context of software development and debugging, using internal data or simulated environments, rather than a clinical training set.

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

   • Not applicable/Not stated. See point 8.

Summary of Device and Submission Type:
The Powerheart® AED G3 devices are Automated External Defibrillators. This 510(k) submission (K102496) is for a software modification to enhance the detection capability of the device's self-test feature. This is a crucial distinction, as it is not a submission for a new AI diagnostic algorithm or an AI-assisted diagnostic tool for which many of the requested performance metrics would be relevant. The submission primarily asserts substantial equivalence to previously cleared predicate devices based on successful software verification and validation testing, confirming the modified software maintains appropriate functional and performance characteristics and doesn't raise new safety/effectiveness concerns.

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The Powerheart® AED G3 Pro, model 9300P, 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 a patient is a child or infant up to 8 years of age, or up to 55 Ibs (25kg), the Powerheart AED G3 Pro 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.

At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with the Model 5111 ECG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and ECG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro ECG Patient Cable, the G3Pro evaluates the patient's ECG and disables its shock capability.

The Powerheart® AED G3Pro 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 deliver the shock energy as required. The Powerheart@ AED G3Pro also has an ECG display and manual override for advanced users. The device in this submission is equivalent to the current Powerheart® ABD and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901, K982710 and K031987. The reason for this premarket notification is to introduce the semi-sutomatic

The provided text is a 510(k) summary for the Cardiac Science Powerheart® AED G3 Pro. This document establishes substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a new, de novo device might. Therefore, many of the requested elements about acceptance criteria, detailed study design, and performance metrics are not explicitly available or are presented indirectly through the claim of substantial equivalence.

Based on the provided text, here's what can be extracted and inferred:

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

The document does not specify quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or positive predictive value. Instead, it asserts that the device modifications (ECG display and manual override) had "no affect on the safety or effectiveness of the device" and that the "device was found to perform as intended." This is based on comparative testing against predicate devices.

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

The document mentions "performance software and hardware evaluations" and "testing" but does not specify:

• The sample size for any test set (e.g., number of patients, number of ECG events).
• The data provenance (country of origin, retrospective or prospective nature of data collection).

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)

The document does not provide details about how ground truth was established for any performance testing, nor does it mention the number or qualifications of experts involved in such a process.

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

The document does not describe any adjudication method used for a test set.

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

The document does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. The device is an AED, and the modifications discussed relate to an ECG display and manual override, not an AI-assisted diagnostic tool for interpretation by human readers.

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

The document states that the Powerheart® AED G3Pro is a "semi-automatic" device, meaning it diagnoses and may advise shock delivery but requires operator action (human-in-the-loop) for therapy. While it performs internal diagnostic algorithms ("software algorithm"), the summary does not detail a standalone algorithm performance study independent of the complete device operation. The focus is on the device as a whole and its equivalence to predicates.

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

The document does not specify the type of ground truth used for any testing. For an AED, ground truth would typically relate to the presence or absence of a shockable rhythm verified by expert cardiologists or electrophysiologists based on ECG analysis or patient outcomes.

8. The sample size for the training set

The document does not refer to a "training set" or provide any sample size for training data. As this is a 510(k) for a device claiming substantial equivalence, the focus is on comparative testing rather than a de novo algorithm development and training process.

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

Since no training set is mentioned, there is no information on how its ground truth might have been established.

Summary of the Study:

The "study" described in this 510(k) notification is primarily a comparative equivalency assessment against previously cleared predicate devices. The modifications introduced in the Powerheart® AED G3 Pro (ECG display and manual override) were evaluated through "performance software and hardware evaluations" and "testing." The reported conclusion is that these modifications did not affect the safety or effectiveness of the device, and it performs as intended, being substantially equivalent to the Powerheart® AED G3 (K031987) and the Philips Medical Systems Heartstream FR2 (K014157, K013425). Specific quantitative performance metrics, detailed study designs, sample sizes, and ground truth methodologies are not provided in this summary, as is typical for 510(k) submissions focusing on substantial equivalence.

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