(312 days)
The LIFEPAK 500 Automated External Defibrillator may be used in the hospital or pre-hospital setting by authorized personnel to terminate certain potentially fatal cardiac arrhythmias.
The LIFEPAK 500 Automated External Defibrillator (AED) is a portable battery powered device which applies a brief, high energy pulse of electricity to the heart via defibrillation electrodes on the chest. A software algorithm analyzes the patients electrocardiogram (BCG) and informs the operator whether it detects a shockable rhythm. The operator can then press the shock button to deliver energy after confirming that the patient is unconscious, pulseless and apneic.
The provided text, a 510(k) summary for the Physio-Control LIFEPAK 500 Automated External Defibrillator (AED), focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting the acceptance criteria and a detailed study proving the device meets those criteria from an AI/algorithm performance perspective.
Here's an attempt to extract and infer the requested information based on the provided text, recognizing that some details might be missing or require interpretation:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the nature of an AED and the AAMI standards cited, the core acceptance criteria for the arrhythmia detection algorithm would be related to its ability to correctly identify shockable rhythms (sensitivity) and non-shockable rhythms (specificity). The document states the device uses the same arrhythmia detection algorithm that is used in the LIFEPAK 300 AED, implying that the performance met the criteria established for the predicate device. However, specific numerical thresholds for sensitivity and specificity are not explicitly stated in this excerpt.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|---|
| Rhythm Detection (Shockable vs. Non-Shockable) | Sensitivity: Ability to detect shockable rhythms | "demonstrates substantial compliance with applicable sections of AAMI DF39-1993" and "rhythm detector function" tests. (Specific numerical performance not provided in this document). |
| Specificity: Ability to correctly identify non-shockable rhythms | "demonstrates substantial compliance with applicable sections of AAMI DF39-1993" and "rhythm detector function" tests. (Specific numerical performance not provided in this document). | |
| Energy Accuracy | Delivery of specified energy levels (per AAMI DF39-1993) | "energy accuracy" tests passed. |
| Pulse Shape and Duration | Conformance to specifications (per AAMI DF39-1993) | "pulse shape and duration" tests passed. |
| Charge Time | Below a specified maximum | "charge time" tests passed. |
| Battery Capacity | Meets operational requirements | "battery capacity" tests passed. |
| Environmental Performance | Operates reliably across specified temperature, humidity, altitude (per AAMI DF39-1993) | "high and low temperature, high and low humidity, altitude" tests passed. |
| Electromagnetic Compatibility (EMC) | Meets relevant standards | "EMC" tests passed. |
| Electrical Safety | Dielectric withstand, leakage current within limits | "dielectric withstand, leakage current" tests passed. |
| Mechanical Durability | Resistance to vibration and shock | "vibration and shock resistance" tests passed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of ECG rhythms/cases) used for the rhythm detection algorithm's test set. It also does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the excerpt. For an AED's rhythm analysis, ground truth for a test set would typically involve expert cardiologists or electrophysiologists labeling ECGs.
4. Adjudication Method for the Test Set
This information is not provided in the excerpt. Common adjudication methods include 2+1 (two agree, one breaks ties) or 3+1 (three agree, one breaks ties).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This document describes a device submission for an AED with an automatic external defibrillator function. The focus is on the algorithm's performance in detecting shockable rhythms, not on assisting human readers in interpreting ECGs. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable and not mentioned. The device's primary function is standalone rhythm analysis followed by operator action.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation of the algorithm's rhythm detection capabilities was implicitly done. The statement "A software algorithm analyzes the patients electrocardiogram (BCG) and informs the operator whether it detects a shockable rhythm" and "rhythm detector function" tests indicate that the algorithm's performance in analyzing ECGs independently was assessed. The 510(k) process for devices like AEDs heavily relies on the standalone accuracy and reliability of their algorithms.
7. The Type of Ground Truth Used
While not explicitly stated, for an AED's rhythm detection algorithm, the most appropriate and likely ground truth would be expert consensus by cardiologists or electrophysiologists based on detailed ECG analysis and potentially clinical correlation from the patients' records. Pathology or outcomes data would be less direct for the rhythm detection algorithm's ground truth, though overall device effectiveness would be linked to outcomes.
8. The Sample Size for the Training Set
This information is not provided in the excerpt.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the excerpt. Similar to the test set, it would typically involve expert review and labeling of ECG data.
In summary of the limitations of the provided text:
The 510(k) summary is designed to demonstrate substantial equivalence, not to detail the full performance study of the algorithm's development and validation in the way a more comprehensive study publication might. It confirms that the device meets relevant standards and that the algorithm is the same as a previously cleared device, implying its performance has been sufficiently validated. Specific metrics for the algorithm's sensitivity and specificity, along with details about the test/training data, expert adjudication, and ground truth establishment, are not included in this high-level summary.
§ 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.