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The AccessAED™ semi-automatic external defibrillator is intended to be used for the treatment of cardiac arrest. The AccessAED should be applied to victims who are unconscious, with absence of breathing, and absence of a detectable pulse.

The AccessALS™ has the capability for manual operation by a user trained in advanced cardiac life support (ALS). In manual mode, the user can select the time for rhythm analysis, device charging, energy level, synchronization, and shock delivery. In the semiautomatic mode, AccessALS functions identically to the AccessAED.

The AccessAED and AccessALS are not currently indicated for children less than 8 years old (less than approximately 25 kgs. or 55 lbs.) The use of the AccessAED and AccessALS should be reviewed after each event and all adverse events should be reported.

Device Description

The AccessAED™ Automatic External Defibrillator has been designed specifically for the treatment of ventricular tachyarrhythmias in cardiac arrest. The AccessAED delivers a high-energy 200 or 360J biphasic waveform to patients in cardiac arrest resulting from ventricular fibrillation or high rate ventricular tachycardia.

The AccessAEDTM features include:

LED ready indicator .
power button .
shock delivery button .
LCD display with text messaging and ECG display option .
defibrillation pads housed in a tray for rapid application to patient .
. disposable Lithium battery system
rhythm analysis software .
energy selection button (manual mode only) ●
synchronization button (manual mode only) .
. analysis button (manual mode only)
charge button (manual mode only) .

When the AccessAED™ algorithm software identifies a rhythm that requires defibrillation, the device charges to the required energy level algorithm (200 J or 360 J) as dictated by the internal algorithm. When the device indicates a full charge and instructs the operator to push the shock button, the operator delivers the shock by pressing the shock delivery button.

AI/ML Overview

The AccessAED Automatic External Defibrillator's acceptance criteria and the study proving it meets these criteria are detailed below. It's important to note that the provided document is a 510(k) summary, which generally focuses on substantial equivalence to predicate devices rather than providing detailed clinical trial results with specific performance metrics against pre-defined acceptance criteria as would be seen in a PMA or extensive clinical study report.

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 for the AccessAED's performance in a clinical setting (e.g., sensitivity, specificity for rhythm analysis, or first-shock success rates against specific thresholds). Instead, the performance is primarily evaluated based on its compliance with industry standards and the demonstrated equivalence of its waveform to predicate devices.

Performance Aspect	Acceptance Criteria (Implicit/Standard)	Reported Device Performance (as stated or implied)
Biphasic Waveform Efficacy	Similar characteristics and results to predicate devices (Heartstream FR2 AED, Physio-Control Biphasic LifePak 500, Zoll M Series Biphasic Defibrillator) and demonstrably effective for defibrillation.	"The efficacy of the biphasic truncated exponential waveform in this device was demonstrated in a study of swine. The results of this study demonstrate the substantial equivalence of the AccessAED biphasic truncated exponential waveform."
"Though there are minor differences in the characteristics of the AccessAED biphasic waveform and its predicate device waveforms, these differences do not raise new questions of safety and efficacy."
Compliance with Industry Standards	Compliance with AAMI DF2-1989 (Cardiac Defibrillator Devices) and AAMI DF39-1993 (Automatic External Defibrillators).	"Performance test data is submitted with the 510 (k) documents. These data demonstrate that the device complies with the applicable sections of AAMI DF2-1989 (Cardiac Defibrillator Devices) and AAMI DF39-1993 (Automatic External Defibrillators)."
Design Control & Hardware Testing	Developed under design control and hardware tested in accordance with established industry standards.	"The device was developed under design control, and the hardware was tested in accordance with established industry standards."
Rhythm Analysis Software Functionality	Identifies rhythms requiring defibrillation and instructs device to charge to appropriate energy (200 J or 360 J).	The device charges to 200 J or 360 J "as dictated by the internal algorithm" when the software identifies a rhythm requiring defibrillation. This is a functional description rather than a performance metric.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document specifies a "study of swine" for waveform efficacy. However, it does not provide the sample size (i.e., number of swine) used in this study.
Data Provenance: The study was conducted on swine (an animal model), not human subjects. The country of origin for the data is not specified. The study appears to be prospective in the context of animal research for device validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of human experts to establish ground truth for the "study of swine." The ground truth for waveform efficacy in an animal study would typically be based on physiological measurements and outcomes directly observed during the experiment. Since it's an animal study focusing on waveform equivalence, the concept of "expert ground truth" as applied to diagnostic image interpretation by clinicians is not directly applicable here.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth was inherently established through the experimental design and physiological measurements in the swine study, not through a consensus of human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported in this 510(k) summary. The device is an automated external defibrillator, where the "AI" (rhythm analysis software) makes decisions independently, instructing the user when to deliver a shock, rather than assisting human readers in interpreting data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the core of the device's function, particularly its rhythm analysis software and energy delivery algorithm, is inherently standalone. The device "identifies a rhythm that requires defibrillation" and "charges to the required energy level algorithm." The human operator's role is to apply the pads, power on the device, and press the shock button when instructed. The "study of swine" for waveform efficacy would be considered a standalone evaluation of the device's fundamental function. The performance data also indicates compliance with AAMI standards, which would include testing of the algorithm's performance in analyzing arrhythmias and delivering shocks.

7. The Type of Ground Truth Used

For the "study of swine" demonstrating waveform efficacy, the ground truth would have been established through physiological measurements and observed outcomes in the swine model, such as successful defibrillation, return of spontaneous circulation, or specific cardiac electrical activity. This is akin to direct experimental observation and measurement.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" sample size. Given this is a 510(k) premarket notification in 2002 for an AED, typical machine learning "training sets" as understood today for AI algorithms were not routinely disclosed or applied in the same manner. The rhythm analysis software would have been developed and validated using a dataset of ECGs, but this is not explicitly described as a "training set" with a specified size.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for any potential "training set" for the rhythm analysis software was established. If such a set existed, it would typically involve annotated ECG waveforms by cardiologists or other experts, but this is speculative given the information provided.

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