(126 days)
The Powerheart Cardiac Rhythm Module (CRM) is intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province or country regulations in which they practice. The Powerheart CRM can be used in three modes: fully automatic mode, advisory mode or manual mode and includes a pacer which allows an operator to deliver external stimuli for temporary transcutaneous cardiac pacing. The Powerheart has previously undergone clinical testing on adults which support the safety and effectiveness of using the device on patients at risk of sudden cardiac arrest who are at least 8 years of age. The device is not classified as a wearable external defibrillator and is not intended for use in the home environment.
The Powerheart Cardiac Rhythm Module (CRM) is a compact, lightweight, automatic external cardioverter defibrillator. It incorporates essential circuitry and software to provide a detection/analysis/defibrillation/pacing system, in a single device, for monitoring and providing therapy to patients at risk for Sudden Cardiac Arrest.
The provided text does not contain the detailed study information required to fill out all the requested fields for acceptance criteria and the study proving the device meets those criteria.
The submission is a 510(k) summary for the Powerheart® Cardiac Rhythm Module™ (CRM™), an Automatic External Cardioverter Defibrillator. While it describes the device's intended use and technological characteristics, it largely references compliance with standards and past clinical testing rather than presenting new study data with acceptance criteria and results.
Here's what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit in the provided text. The text states: "The performance tests conducted on the Powerheart Cardiac Rhythm Module will be subjected to pre-determined pass criteria that will support claims of substantial equivalence." This indicates that such criteria exist, but they are not detailed here. | Not explicit in the provided text. The text states: "The performance tests conducted on the Powerheart Cardiac Rhythm Module will follow the applicable portions of the ANSIAAMI DF2 and DF39 requirements for cardiac defibrillator devices and automatic external defibrillators to demonstrate the safety and efficacy of the CRM device." This implies the device performed adequately against these standards, but specific performance metrics are not given. |
Missing Information:
- Specific numerical or statistical thresholds for performance (e.g., sensitivity, specificity, accuracy for arrhythmia detection; energy delivery capabilities, pacing parameters).
- Actual results of the performance tests against these criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Missing Information. The document mentions: "The Powerheart has previously undergone clinical testing on adults which support the safety and effectiveness of using the device on patients at risk of sudden cardiac arrest who are at least 8 years of age." However, it does not provide details about:
- The sample size of this previous clinical testing.
- Whether the data was prospective or retrospective.
- The country of origin for the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Missing Information. This level of detail is not mentioned in the provided text, as the document primarily refers to compliance with performance standards (ANSIAAMI DF2 and DF39) rather than a specific clinical validation study with expert-adjudicated ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Missing Information. Similar to point 3, this detail is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable/Missing Information. The device described is an Automatic External Cardioverter Defibrillator (AED) and a pacing device. While it uses "FDA-cleared and patented arrhythmia detection software," it's not a diagnostic aid where human readers or their improvement with AI assistance would typically be measured. The device automatically detects and delivers therapy or advises the operator to shock, or is used in manual mode. Therefore, an MRMC study related to human reader improvement with AI assistance is not described or relevant for this type of device based on the provided text.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Partially Addressed / Implied.
- The "Fully Automatic Mode" implies standalone algorithm performance as it "automatically provides defibrillation therapy."
- The document states: "The Powerheart CRM utilizes an FDA-cleared and patented arrhythmia detection software that continuously monitors, detects and delivers therapy..."
- The performance tests follow "applicable portions of the ANSIAAMI DF2 and DF39 requirements," which would include testing the device's automated detection and therapy delivery algorithms. However, a specific "standalone study" with detailed results (like sensitivity/specificity for arrhythmia detection) is not presented.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Missing Information. For the "previously undergone clinical testing," the method for establishing ground truth is not specified. For the performance tests against ANSIAAMI standards, these standards typically involve specific test signals and simulated conditions, which serve as the "ground truth" for evaluating the device's response.
8. The sample size for the training set:
Missing Information. The document mentions "FDA-cleared and patented arrhythmia detection software," which indicates development and likely a training phase. However, no details about the training set size are provided.
9. How the ground truth for the training set was established:
Missing Information. No information is given regarding the training set or its ground truth establishment.
In summary: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device and compliance with relevant standards (ANSIAAMI DF2 and DF39). It explicitly states that performance tests were conducted and will be subjected to pre-determined pass criteria, but it does not present the detailed results, acceptance criteria, or study methodologies (like sample sizes, ground truth establishment, or expert involvement) that would be found in a comprehensive clinical or performance study report.
§ 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.