(505 days)
For emergency treatment of patients in cardiac arrest who are unconscious and lack pulse and spontaneous breath. The device may be used for automated ECG analysis or, alternatively as a standard cardiac monitor for manual BCG assessment.
The LIFEPAK 300 is a portable external cardiac defibrillator. It can operate in either the semi-automated mode or the manual mode. A lesser trained emergency responder such as an EMT can use the device in the semi automated mode; the device analyzes the cardiac rhythm and indicates "shock advised" if it detects a shockable rhythm. If the device is in the manual mode a person trained in cardiac rhythm interpretation, such as a paramedic, can deliver a defibrillation shock without relying on the automated analysis of the device.
This document describes the acceptance criteria and supporting study for the Physio-Control Corporation LIFEPAK 300 automated external defibrillator (modified) (K962359).
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a readily extractable format. It mentions "qualification testing and software/system validation testing" were provided. However, the key modification and implied performance relates to the device's ability to allow shock delivery in the presence of motion if a shockable rhythm is detected, which the unmodified version would not. Without explicit performance data provided in the summary, we cannot create a precise table.
Implied Performance Focus: The primary functional change is allowing shock delivery in the presence of motion when a shockable rhythm is detected, unlike the predicate device. The performance would be assessed on the accuracy of rhythm analysis under these specific conditions.
2. Sample Size and Data Provenance for Test Set
The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "qualification testing and software/system validation testing."
3. Number and Qualifications of Experts for Ground Truth (Test Set)
The 510(k) summary does not specify the number of experts used to establish ground truth for the test set or their qualifications.
4. Adjudication Method for Test Set
The 510(k) summary does not describe any adjudication method used for establishing ground truth on the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is an automated external defibrillator, and its performance evaluation typically focuses on the accuracy of its automated rhythm analysis, rather than human reader improvement with AI assistance.
6. Standalone Performance Study
Yes, a standalone study of the algorithm's performance was implied by the mention of "qualification testing and software/system validation testing." The device operates in a "semi-automated mode" where it "analyzes the cardiac rhythm and indicates 'shock advised' if it detects a shockable rhythm." This indicates that the algorithm's ability to accurately detect shockable rhythms is a core performance characteristic assessed in standalone mode. However, specific metrics of this standalone performance are not provided.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated. However, given the nature of an automated external defibrillator, the ground truth for rhythm analysis in testing would typically be established by:
- Expert Consensus: Review of ECG waveforms by qualified cardiologists or electrophysiologists.
- Known Rhythm Libraries: Using pre-recorded ECGs with confirmed diagnoses of shockable (e.g., ventricular fibrillation, pulse-less ventricular tachycardia) and non-shockable rhythms.
- Experimental/Simulated Data: Where the cardiac rhythm can be precisely controlled and known.
8. Sample Size for Training Set
The 510(k) summary does not provide details on the sample size for any training set used for the device's software/algorithm. This information is typically not detailed in the public 510(k) summary for such devices unless it's a novel AI/ML device where this is a primary focus.
9. How Ground Truth for Training Set Was Established
The 510(k) summary does not provide details on how the ground truth for any training set was established. Similar to the test set, it would likely involve expert review of ECGs, known rhythm databases, or controlled experimental data.
§ 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.