(73 days)
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).
§ 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.