(230 days)
The Powerheart® Automatic External Cardioverter Defibrillator (AECD)® system is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tacharrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.
The Powerheart Automatic External Cardioverter Defibrillator monitors a patient's cardiac electrical activity and treats ventricular tacharrhythmias. The Powerheart senses the ECG signal using one set of electrodes, and delivers cardioversion and/or defibrillation energy through another set of electrodes. The cardioversion/defibrillation electrodes are positioned on the patient either transchest or anterior-posteriorly . 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 selects the appropriate (i.e., as pre-set by the patient's physician) electrical countershock for delivery attempt restoring normal cardiac rhythm. Should the arrhythmia continue, the Powerheart will proceed with subsequent delivery of energy (as pre-set by the patient's physician) after each additional evaluation and charging period. Depending upon the physician programmed parameters, the Powerheart may deliver a maximum of eight pulse sequences. Then, the Powerheart will deliver no further therapy automatically until 60 seconds of consecutive non-shockable rhythm is presented or the device is reset manually.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardiac Science Powerheart® Automatic External Cardioverter Defibrillator (AECD®):
Acceptance Criteria and Device Performance:
The provided 510(k) summary does not explicitly state quantitative acceptance criteria or a detailed table of reported device performance in terms of specific metrics like sensitivity, specificity, or positive/negative predictive values for arrhythmia detection or treatment success rates. Instead, it refers to conformance with applicable voluntary standards and that the device "performs according to its specifications."
The closest the document comes to defining "acceptance criteria" for performance is:
- "The Powerheart AECD was mechanically and functionally tested to demonstrate conformance with applicable section of the ANSI/AAMI voluntary standard DF39-1993 for Automatic External Defibrillators and Remote Control Defibrillators, the ANSI/AAMI Standard ES1-1993, Safe Current Limits for Electromedical Apparatus, and UL544."
- "The testing demonstrated that the device performs according to its specifications."
- "Data from a clinical investigation of the Powerheart AECD demonstrated that the device is able to safely and effectively treat ventricular tacharrhythmias according to the device specifications."
Since specific numerical acceptance criteria (e.g., "sensitivity must be >XX%") are not provided, I cannot create a table with reported device performance against such criteria. The "reported performance" is broad conformance and ability to safely and effectively treat.
Study Details:
Given the lack of specific detail in the provided text, many fields below will be marked as "Not Provided."
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1. A table of acceptance criteria and the reported device performance
Acceptance Criteria (Stated or Implied) Reported Device Performance Conformance with ANSI/AAMI DF39-1993 (AEDs) Device performs according to its specifications. Conformance with ANSI/AAMI ES1-1993 (Safe Current Limits) Device performs according to its specifications. Conformance with UL544 Device performs according to its specifications. Software performs according to specifications (per FDA Reviewer Guidance for CCD) Software performs according to its specifications. Able to safely and effectively treat ventricular tachyarrhythmias (clinical investigation) Device is able to safely and effectively treat ventricular tachyarrhythmias according to device specifications. -
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not Provided. The document mentions "Data from a clinical investigation" but gives no details on the number of patients or cases.
- Data Provenance:
- Country of Origin: Not Provided.
- Retrospective/Prospective: Not Provided. It's described as a "clinical investigation," which typically implies prospective data collection, but this is not explicitly stated.
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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)
- Not Provided. The document mentions "clinical investigation" but offers no details on ground truth establishment methods or expert involvement.
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4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Provided.
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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/Not Provided. This device is an Automatic External Cardioverter Defibrillator (AECD), meaning it's primarily an automated device for arrhythmia detection and treatment, not an AI-assisted diagnostic tool for human readers in the typical MRMC study context. The "clinical investigation" would be assessing the device's direct performance, not how it improves human interpretation.
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6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Yes, implicitly. The device is described as "Automatic External Cardioverter Defibrillator," which functions in a standalone manner to detect and treat arrhythmias. The "clinical investigation" assessed the device's ability to "safely and effectively treat ventricular tacharrhythmias," implying standalone performance evaluation.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Explicitly Provided. For a defibrillator, the "ground truth" for successful treatment of ventricular tachyarrhythmias would likely be rhythm conversion to a non-shockable rhythm, as assessed by ECG monitoring and patient status. However, the exact methods or criteria are not detailed in the summary. It would fall under "outcomes data" related to rhythm status.
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8. The sample size for the training set
- Not Applicable/Not Provided. The term "training set" is typically used for machine learning models. While the device uses "a combination of rate and (if programmed by the physician) morphology to determine the presence of shockable arrhythmias," it's not described as a deep learning or AI model that would require a distinct "training set" in the modern sense. It likely uses rule-based algorithms or traditional signal processing. The "software" was developed and tested to its specifications, but no mention of a traditional machine learning training set.
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9. How the ground truth for the training set was established
- Not Applicable/Not Provided (see answer to #8).
§ 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.