(126 days)
The G5 Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response.
An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Postresuscitation, if the patient 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 a shock, or for an automatic AED, automatically deliver a shock if needed.
When a patient is a child up to 8 years of age, or up to 25kg (55 lbs), the AED should be used with the Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient's exact age or weight.
The optional CPR Device offers CPR performance feedback to aid a trained rescuer by providing compression rate and depth performance feedback through audio prompting. The CPR Device is indicated for use on cardiac arrest patients 8 years of age or older, or who weigh more than 25 kg (55 lbs).
The Powerheart® G5 AED is a portable, battery operated, self-testing defibrillator used to diagnose and treat life threatening ventricular arrhythmias in patients who are unresponsive and not breathing or not breathing normally. This is accomplished by monitoring the patient's ECG and delivering a defibrillation shock if necessary.
The AED is intended to be used by a person designated within a community, locale or building who is the first responder to a medical emergency. This typically includes ambulance, police or fire fighting personnel, emergency response team members, security personnel, and lay persons who have been trained in CPR and in the use of the AED.
The Powerheart® G5 AED guides the user through a rescue using voice or text prompts. Defibrillation pads are used to monitor and defibrillate patients. Defibrillation pads, meant for patients older than 8 years or heavier than 55 lb, are preconnected to the Powerheart G5 AED and placed in two locations on the patient during a rescue. Pediatric pads are connected to the AED when a pediatric patient is involved and meant for use on those patients 8 years or younger, or 55 lb or lighter.
The Powerheart® G5 CPR Device (CPRD), used in conjunction with the G5 AED, is a single use tool that provides CPR performance feedback to aid a CPR trained rescuer in the performance of CPR. The CPRD provides compression rate and depth audio feedback. CPR measurements are recorded for post-event review.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powerheart G5 AED with optional CPR device:
Acceptance Criteria and Device Performance for Powerheart G5 AED with CPR Device
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on stated testing) | Reported Device Performance (Summary) |
|---|---|---|
| Functional Performance | Device performs as intended for diagnosing and treating life-threatening ventricular arrhythmias and delivering defibrillation. | "The G5 passed all software and hardware tests and was found to perform as intended." |
| Software Integrity | Software reliability, functionality, and adherence to requirements. | "Software white box testing... unit and integration testing... used to verify software requirements and functionality. Black box testing was conducted to ensure each device requirement was tested. Software analysis was performed using a static analysis tool." |
| Hardware Integrity | Hardware qualification, functional performance, and risk mitigation. | "Hardware was qualified and functional testing was conducted to verify requirements and functionality. Design Failure Modes and Effects Assessments were completed for each PCBA contained within the AED and accessories." |
| Human Factors | Ease of use and non-interference of the CPR Device with AED operation. | "Each participant was able to apply the CPR Device, which was shown to not delay or distract from the correct use of the AED." |
| CPR Performance Feedback | Provides accurate compression rate and depth audio feedback. Guides users with corrective voice prompts if CPR deviates from AHA guidelines. | (Implicit in "The Powerheart® G5 AED... will provide prompting to the user... instruct the user... If the AED recognizes CPR chest compressions that deviate from the AHA guidelines, the AED will provide corrective voice prompts.") |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set used in the functional, software, hardware, or human factors studies.
- Test Set Description:
- Functional/Software/Hardware Testing: No specific number of test cases or data points is mentioned. The description suggests comprehensive testing (white box, black box, unit, integration).
- Human Factors: "Each participant" implies a finite number of individuals, but the exact count is not provided.
- Data Provenance: Not specified. The studies appear to be internal company evaluations, so the data would be proprietary/internal. No mention of country of origin or whether it's retrospective or prospective is made.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of external experts for establishing ground truth within the context of these engineering and human factors tests. The ground truth for functional, software, and hardware performance would typically be established based on engineering specifications, industry standards, and internal quality assurance protocols. For human factors, the success criteria (e.g., proper application, no delay/distraction) would have been predefined by the study designers.
4. Adjudication Method for the Test Set
No adjudication method is described, as the studies are primarily technical performance and human factors evaluations rather than diagnostic accuracy studies requiring multiple expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The evaluation focuses on the safety and effectiveness of the device itself and its substantial equivalence to predicate devices, not on the improvement of human readers' performance with AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
The device, an Automated External Defibrillator (AED), inherently operates with significant automated functions (ECG analysis, shock advisory/delivery). The studies described are implicitly evaluating the standalone performance of these automated functions (software and hardware evaluation). The human factors test evaluates the interaction with the human user, not the delegation of diagnostic tasks from a human to the algorithm, or the improvement of the human's diagnostic ability. Therefore, yes, standalone (algorithm-only) performance was assessed for the core AED functionality.
7. Type of Ground Truth Used
- Functional/Software/Hardware: The ground truth for these tests is based on engineering specifications, design requirements, and industry standards (e.g., for defibrillation accuracy, timing, CPR feedback parameters). Tests aim to verify that the device's output matches these predefined correct behaviors.
- Human Factors: The ground truth for the human factors study would be pre-defined success criteria for proper device usage and the absence of factors delaying or distracting rescuer performance.
8. Sample Size for the Training Set
No information about a training set for an AI/machine learning model is provided. This device is an AED with CPR feedback, and the description of its software evaluation does not indicate the use of machine learning that would require a distinct "training set" in the context of predictive algorithms. The software validation is traditional verification and validation against requirements and design.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of machine learning, this question is not applicable based on the provided document.
§ 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.