(97 days)
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 Powerheart monitors a patient's cardiac electrical activity and detects and treats ventricular tachyarrhythmias. The patient is connected to the device by a patient cable which is attached to both a set of ECG electrodes and a set of defibrillation electrodes. The defibrillation electrodes can be positioned on the patient sternum- apex or anterior-posteriorly. The operator can program the device during set up to use either the ECG electrodes or the defibrillator electrodes to sense ECG. The Powerheart uses a combination of rate and, if programmed by the physician, morphology to determine the presence of shockable arrhythmias. When a shockable arrhythmia is detected, the system delivers cardioversion and/or defibrillation energy through defibrillator electrodes to restore normal cardiac rhythm. Should the arrhythmia continue, the Powerheart will deliver additional electrical countershocks after each subsequent evaluation and programmed delay. Depending upon the programmed parameters as prescribed by the physician, the Powerheart may deliver a maximum of nine pulse sequences. In the event that nine pulse sequences have been delivered, the Powerheart will not automatically deliver any further therapy until: 1) a new shockable rhythm is detected after 60 consecutive seconds of non-shockable rhythm is presented, or 2) the device is reset manually. The energy levels for each individual countershock are also programmed into the device per the physician's prescription.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific pass/fail acceptance criteria values (e.g., "sensitivity must be > X%", "specificity must be > Y%"). Instead, it confirms that the device was deemed "as safe based on the non-chilical performance tosting, and the predicate device." This suggests a comparative approach where the performance of the new device was evaluated against the established performance of the predicate device (Powerheart® AECD® cleared under K970741).
The study lists a series of non-clinical tests performed, implying that successful completion of these tests serves as the "acceptance criteria" for demonstrating safety and effectiveness comparable to the predicate.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| System Validation | Concluded as safe and as effective as the predicate device. |
| Observation of Requirements Implementation | Concluded as safe and as effective as the predicate device. |
| Analysis Tests | Concluded as safe and as effective as the predicate device. |
| Battery System Tests | Concluded as safe and as effective as the predicate device. |
| Defibrillation Related Performance | Concluded as safe and as effective as the predicate device. |
| Alarm System Tests | Concluded as safe and as effective as the predicate device. |
| Environmental Testing | Concluded as safe and as effective as the predicate device. |
| Electrical Safety Testing | Concluded as safe and as effective as the predicate device. |
| Functional Safety Testing | Concluded as safe and as effective as the predicate device. |
| Electromagnetic Compatibility (EMC) Testing | Concluded as safe and as effective as the predicate device. |
| ECG Channel/Defibrillator Pad ID | Concluded as safe and as effective as the predicate device. |
| Quality and Reliability | Concluded as safe and as effective as the predicate device. |
| Human Factors | Concluded as safe and as effective as the predicate device. |
| System Software Validation and Verification | Concluded as safe and as effective as the predicate device. |
| Arrhythmia Detection Software Verification and Validation | Concluded as safe and as effective as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only lists categories of non-clinical tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any test set. Given the non-clinical nature of the listed tests, it's possible that internal engineering and validation teams were involved rather than external clinical experts for the direct evaluation of the device's
arrhythmia detection software.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device itself and its comparison to a predicate device, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, a standalone performance evaluation of the "Arrhythmia Detection Software" was performed, as indicated by "Arrhythmia Detection Software Verification and Validation" under non-clinical tests. The document implies that the software's performance (specifically its detection capabilities) was deemed equivalent to the predicate device's software.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. For arrhythmia detection software validation, it would typically involve a reference standard derived from expert-annotated ECG recordings, often from established arrhythmia databases.
8. Sample Size for the Training Set
The document does not provide information on the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established.
§ 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.