(6 days)
The AECD Arrhythmia Detection Software, when loaded into the Powerheart AECD is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.
The Cardiac Science, Inc., AECD Arrhythmia Detection Software is simply the "arrhythmia detector" software program which is the primary component of the unmodified Powerheart AECD (K970741).
This is a computer software program which analyzes the patient's ECG waveform and determines whether the patient exhibits a non-shockable rhythm, based upon the physician programmed parameters for the patient.
This software is not a standalone medical software device. The AECD Arrhythmia Detection Software will be marketed as a component intended to enhance the performance of defibrillators and/or patient monitors by adding this functionality to those products.
This document describes the AECD® Arrhythmia Detection Software®, solely referring to the software component of a previously cleared device, the Powerheart® AECD®.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or a specific table for the performance of the AECD Arrhythmia Detection Software as a standalone submission. Instead, it refers to the performance of the Powerheart AECD (K970741), of which this software is a component.
Therefore, the table below reflects what can be inferred about the software's performance from the context of its predicate device, as directly stated performance metrics for the software alone are not provided in this specific submission.
| Acceptance Criteria (Inferred from Predicate Device) | Reported Device Performance (Inferred for Software) |
|---|---|
| Performance according to specifications (for arrhythmia detection) | Performs according to its specifications (as part of the Powerheart AECD) |
| Ability to acquire electrocardiograph rhythm | Acquires electrocardiograph rhythm |
| Detection of ventricular tachyarrhythmias | Detects ventricular tachyarrhythmias |
| Ability to determine non-shockable rhythms based on programmed parameters | Determines non-shockable rhythms based on physician programmed parameters |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "bench testing using standard ECG databases" and "clinical data resulting from IDE Application G920078" from the predicate device (Powerheart AECD, K970741).
- Sample Size for Test Set: Not specified in this document. It mentions "standard ECG databases" for bench testing and "clinical data" from an IDE. To find the exact sample size, the predicate device's (K970741) submission would need to be reviewed.
- Data Provenance:
- Bench Testing: Standard ECG databases (specific origin not detailed in this document).
- Clinical Data: From IDE Application G920078 (no country of origin or retrospective/prospective nature specified in this document, but IDEs are typically prospective clinical trials).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not specified in this document. The document only mentions "standard ECG databases" and "clinical data," but provides no details on how ground truth was established for these datasets, nor the number or qualifications of experts involved.
4. Adjudication Method for the Test Set:
Not specified in this document.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study is not mentioned in this document. The device is a "computer software program which analyzes the patient's ECG waveform," implying an automated detection system, not one that assists human readers.
6. Standalone (Algorithm Only) Performance:
Yes, a standalone performance evaluation of the algorithm was done. The document explicitly states: "Bench testing was performed using standard ECG databases prior to the clinical trials. Testing demonstrated that the software performs according to its specifications." This refers to the algorithm's performance without human interaction.
7. Type of Ground Truth Used:
Based on the description of the device's function (detecting ventricular tachyarrhythmias and non-shockable rhythms) and the use of "standard ECG databases" and "clinical data," the ground truth likely involved:
- Expert Consensus/Diagnosis: For clinical data, this would involve diagnoses made by cardiologists or electrophysiologists.
- Reference Annotations: For standard ECG databases, these often contain expert-annotated rhythm labels, which serve as ground truth for algorithm training and testing.
8. Sample Size for the Training Set:
Not specified in this document. The document refers to "standard ECG databases" which are often used for both training and testing, but separates them as "bench testing prior to clinical trials." The size of any training set used for the software's development is not detailed.
9. How the Ground Truth for the Training Set Was Established:
Not specified in this document. As with the test set, it can be inferred that expert annotations or diagnoses, typical for ECG databases, would have been used.
§ 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.