(520 days)
The GS 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 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. Adult 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 resoue. 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 provided text describes the Powerheart® G5 AED and its intended use, but it does not contain any specific acceptance criteria or details of a study proving the device meets acceptance criteria related to its diagnostic or therapeutic efficacy. The document is a 510(k) summary for premarket notification, focusing on demonstrating substantial equivalence to a predicate device.
The "Functional Tests" section (F) merely states: "The Powerheart® G5 AED was subjected to performance hardware and software evaluations in accordance with industry standards. The G5 passed all software and hardware tests and was found to perform as intended." This is a very general statement and does not provide specific acceptance criteria or study results.
Therefore, I cannot provide the requested information from the given text. The text does not detail:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or their acceptance thresholds are mentioned.
- Sample size used for the test set and the data provenance: No test data or information about the test set is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on ground truth establishment is given.
- Adjudication method for the test set: Not applicable as no test set details are provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
- If a standalone performance study was done: No standalone performance study details are provided.
- The type of ground truth used: Not specified.
- The sample size for the training set: No information on training data is provided.
- How the ground truth for the training set was established: Not specified.
This document focuses on demonstrating that the Powerheart® G5 AED is substantially equivalent to the Powerheart® AED G3 based on indications for use, technological characteristics, materials, and a conceptual "software algorithm," but it does not delve into the detailed performance evaluation against specific clinical or technical acceptance criteria.
§ 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.