Search Results

Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by: Unconsciousness and Absence of normal breathing and Absence of a pulse or signs of circulation. When a victim is less than 8 years of age, or weighs less thank 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

The device is a lightweight, portable, battery-powered semi-automatic external defibrillator that uses voice prompts and visual icons to guide a user through a cardiac arrest rescue. The device utilized the ZOLL Rectilinear Bi-Phasic defibrillation waveform. The device is designed to be used by trained responders for the treatment of cardiac arrest. When connected with ZOLL AED Plus defibrillation electrodes to a patient, the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a shockable rhythm, the device charges the capacitor, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. If the device detects a non-shockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that mesures the depth of CPR compressions. This information is used by the device to provide feedback to the user and encourage the user to administer CPR in compliance with the American Heart Association (AHA) Guidelines. The device provides feedback in the form of a metronome (to encourage the proper CPR frequency of 100 compressions per minute) and a visual depth indicator on the display (to encourage the recommended compression depth).

Here's an analysis of the acceptance criteria and study information for the ZOLL AED Plus with the 2010 AHA Guidelines Software Update, based on the provided text.

Based on the provided text, the device in question is a software update for an existing Automatic External Defibrillator (AED), the ZOLL AED Plus. The update primarily changes the CPR compression depth feedback to align with the 2010 AHA Guidelines.

It is critical to understand that this submission is a 510(k) for a software update to an already cleared device, not a new device requiring extensive clinical trials for a de novo clearance. This means the performance testing primarily focuses on demonstrating that the updated software maintains the safety and effectiveness of the predicate device and meets the new CPR depth recommendations.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format that would typically be seen for a new device's diagnostic performance (e.g., sensitivity, specificity for a diagnostic algorithm). Instead, the "acceptance criteria" implicitly relate to adhering to the new AHA guidelines and demonstrating substantial equivalence to the predicate device.

Study Details

Given the nature of a software update for an already cleared device, the "study" described is a performance testing and safety testing regimen, rather than a clinical trial validating a novel diagnostic algorithm.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • The document does not specify a sample size for a "test set" in the context of diagnostic accuracy.
   • The "performance testing" and "safety testing" mentioned are likely internal engineering and validation tests, not typically involving "test sets" of patient data in the same way a diagnostic AI would. Details on the data provenance (country, retrospective/prospective) are also not provided.

2. 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):

   • This information is not applicable/not provided. The "ground truth" for this device's performance relates to its ability to accurately measure and provide feedback on CPR depth and frequency according to the new AHA guidelines and to perform its core defibrillation function as per the predicate device. This would be validated through engineering and functional testing, not expert consensus on medical images or physiological signals.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not applicable/not provided. Adjudication methods are typically used in clinical studies involving human interpretation or uncertain outcomes, which is not the primary focus of this software update.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that aid human interpretation (e.g., radiologists reading scans). The ZOLL AED Plus is a device that provides direct feedback based on physiological measurements (CPR depth, rhythm analysis), not an AI assisting a human "reader" in a diagnostic task.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. The device's core functions (rhythm analysis, CPR feedback) operate "standalone" in the sense that the algorithm processes inputs (ECG, accelerometer data) and provides outputs (shock/no shock, CPR prompts). The performance testing would have validated these algorithmic modifications. However, it's crucial to note that an AED always requires a human operator to physically administer CPR and deliver the shock, so "standalone performance" here refers to the algorithm's accuracy in its functions, not that the device operates without human interaction during a rescue.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for rhythm analysis is well-established through clinical standards and validated algorithms.
   • For the CPR feedback, the ground truth is based on engineering measurements of compression depth (e.g., using a force plate or sensor to verify the accelerometer's accuracy) and frequency, adhering to the specified 2010 AHA Guidelines.
   • The overall safety and effectiveness rely on demonstrating equivalence to the predicate device, which itself would have been validated against established medical standards.

7. The sample size for the training set:

   • This information is not provided and is largely not applicable in the context of this specific regulatory submission. Modern AI systems often require large training datasets, but this device's algorithms for rhythm analysis and CPR feedback are likely based on established physiological principles and signal processing, rather than deep learning requiring extensive "training sets" in the contemporary AI sense. If any machine learning was used for the accelerometer-based CPR feedback, the training data details are not disclosed.

8. How the ground truth for the training set was established:

   • Not explicitly described. For the core functions of an AED, the ground truth for algorithms is typically established through:
     • Physiological models: Simulations and testing with controlled inputs.
     • Clinical data from previous generations/studies: ECG databases with adjudicated rhythms.
     • Engineering validation: Direct measurement of physical parameters (e.g., force, depth) using calibrated equipment.
   • For the CPR feedback, the "ground truth" for the desired performance parameters is objectively defined by the 2010 AHA Guidelines (e.g., 2.0 inches minimum depth, 100 compressions/minute, full recoil). The training of the device, if any, would involve calibrating its sensors to accurately reflect these physical parameters.

Summary Takeaway:

This 510(k) submission is for a minor software update to an already cleared Class III medical device (AED). The "performance testing" described is primarily focused on verifying that the software changes correctly implement the updated CPR guidelines (specifically compression depth and recoil feedback) and that these changes do not adversely affect the overall safety and effectiveness of the device compared to its predicate. It is not a submission for a new diagnostic AI system, and therefore, many of the typical AI study parameters (e.g., large test/training sets of patient data, expert adjudication, MRMC studies) are not present or not relevant to this specific regulatory review. The safety and functional performance tests would be internal validation studies, not clinical trials in the traditional sense.

Ask a specific question about this device