(282 days)
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
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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."
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.