(116 days)
Defibrillation is a means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. The AED mode is for use on patients in cardiopulmonary arrest. Pacing is used to treat symptomatic bradycardia and asystole. ECG monitoring is used for identifying and diagnosing cardiac rhythms and dysrhythmias and calculating heart rate. Pulse oximetery is used to check the saturation of in the arterial blood of patients who are at risk of developing hypoxemia.
The LIFEPAK 12 defibrillator/monitor series is a complete acute cardiac response system - battery or auxiliary powered defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system
The provided 510(k) summary for the Physio-Control LIFEPAK® 12 defibrillator/monitor/pacemaker system does not contain a detailed study with specific acceptance criteria and performance results in the format requested.
Instead, the document states that "Information is provided in the 510(k) regarding compliance to applicable sections of the following voluntary industry standards and FDA guidance documents:" followed by a list of standards for diagnostic electrocardiographic devices, cardiac monitors, cardiac defibrillator devices, and automatic external defibrillators. It concludes by saying, "This information demonstrates that the LIFEPAK 12 is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance."
Therefore, based on the provided text, I cannot complete the table and answer all points as specific study details are not given. The submission relies on compliance with existing industry standards rather than a new standalone clinical study with explicit acceptance criteria and corresponding performance metrics for the device itself.
Here's a breakdown of what can and cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document refers to compliance with industry standards, but does not list specific numerical acceptance criteria or performance metrics for the LIFEPAK 12 itself beyond stating substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance
Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not available in the provided text.
4. Adjudication method for the test set
Not available in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device described is a defibrillator/monitor/pacemaker system, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not explicitly stated in the context of a "study" with performance metrics. The device's automated functions (like AED mode) would inherently operate in a "standalone" fashion, but performance data is not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not available in the provided text.
8. The sample size for the training set
Not available in the provided text.
9. How the ground truth for the training set was established
Not available in the provided text.
§ 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.