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Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by

• Unconsciousness .
• Absence of breathing, and .
• Absence of pulse and other signs of circulation. .

When the victim is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL pediatric defibrillation electrodes: Do not delay therapy to determine the patient's exact age or weight.

The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.

The ZOLL AED Pro® is a portable, battery powered automated external defibrillator (AED) that uses voice prompts and visual messages to provide feedback to a user attempting a cardiac arrest rescue. The AED Pro acquires and analyzes an adult or pediatric patient's ECG signal and, if a shockable rhythm is detected, recommends delivery of a defibrillation shock via voice and visual prompts.

The ZOLL AED Pro software, which currently supports the 2005 American Heart Association Guidelines for CPR and ECC, has been revised to optionally support the 2010 American Heart Association Guidelines for CPR and ECC. The specific changes include:

• changing the depth indicator on the device screen from 1.5 inches to 2.0 inches .
• prompting the user to "push harder" when compressions are less than 2.0 inches . instead of less than 1.5 inches in the previous release
• adding a text prompt to remind the rescuer to "Fully Release" the patient's . chest during CPR

The provided document describes a 510(k) premarket notification for a software update to the ZOLL AED Pro, aligning it with the 2010 American Heart Association Guidelines for CPR and ECC. The focus is on CPR monitoring and defibrillation.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a pass/fail quantifiable manner for the software update, but rather describes the changes made to comply with new guidelines and implies that the device meets these new guideline requirements. The performance testing section states that the device "meets all of its functional requirements and performance specifications" and "demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."

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

The document broadly mentions "Extensive performance testing," but does not provide any specific sample sizes for test sets used to validate the software changes. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any testing performed.

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

The document does not mention the use of experts to establish ground truth for a test set related to this software update. The basis for the software changes is the 2010 American Heart Association Guidelines, which are consensus-based expert recommendations, but not a specific ground truth determination for device testing.

4. Adjudication Method for the Test Set:

Since there is no mention of a test set where ground truth was independently established by experts, no adjudication method is described in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus of this 510(k) is a software update to align with new guidelines, not an assessment of human reader improvement with or without AI assistance.

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

The document states "Extensive performance testing ensures that the ZOLL AED Pro Defibrillator meets all of its functional requirements and performance specifications." While this implies algorithm-only testing to ensure it correctly implements the new guidelines, it does not explicitly detail a standalone performance study with specific metrics for the algorithm's performance. The context is a software change to a device that has "human-in-the-loop" by design (an AED).

7. The Type of Ground Truth Used:

The ground truth for the design criteria of the software update is the 2010 American Heart Association Guidelines for CPR and ECC recommendations. For the device's overall performance validation, the ground truth is implicitly related to "functional requirements and performance specifications" and comparison to "commercially distributed predicate devices" to establish substantial equivalence. However, no specific ground truth (like pathology, outcomes data, or expert consensus on specific cases) for a test set is explicitly described in the context of this software update.

8. The Sample Size for the Training Set:

The document does not mention a training set or its sample size. This is a software update to an existing device based on updated clinical guidelines, not the development of a new AI/machine learning model that typically requires a training set.

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

Since there is no mention of a training set, this information is not applicable and not provided in the document.

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