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The CPR RsQ Assist is intended to assist the rescuer in performing chest compressions at the recommended American Heart Association (AHA) rate of 100 compressions/minute on a victim 8 years or older.

The CPR RsQ Assist consists of a rigid plastic top with an integrated plastic support collar, a flexible plastic bellows filled with foam, and a removable silicone base platform. LED lights and a speaker component provide visual and audio cues, respectively, to the user during manual CPR compressions. The CPR RsQ Assist is provided non-sterile.

The provided 510(k) summary for AvanTech, Inc.'s CPR RsQ Assist describes performance data based solely on bench testing. It does not include clinical studies involving human subjects or extensive AI/algorithm-based performance assessments typically associated with the detailed criteria requested.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states "bench testing" and "simulated use on conventional CPR manikin."

• Sample Size: Not specified for any of the tests. It is likely a small number of devices or test cycles typical of bench testing.
• Data Provenance: Not human data. Derived from in-house bench testing and simulated use experiments. No country of origin for data as it's not clinical. Retrospective or prospective is not applicable as it is not human data.

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

• Number of Experts: Not applicable. The ground truth for bench testing is typically derived from engineering specifications, industry standards (e.g., AHA guidelines for CPR rate/depth), and recognized test methodologies. There's no mention of human expert consensus for these physical and functional tests.
• Qualifications of Experts: Not applicable. The "ground truth" here is the expected performance based on design and standards, not expert interpretation of data.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers assess the same cases and their disagreements need to be resolved. This document describes physical, electrical, and functional bench tests where outcomes are objective measurements against defined standards.

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

• MRMC Study: No. The device is a "Cardiopulmonary Resuscitation Aid" providing real-time feedback (visual and auditory cues), not an AI-driven image analysis tool or diagnostic algorithm that would typically be evaluated in an MRMC study. There is no mention of "AI" in the document.
• Effect Size: Not applicable as no MRMC study was conducted.

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

• Standalone Performance: Not applicable in the context of typical AI algorithm evaluation. The device itself is designed to work as an assist with a human in the loop (a rescuer). Its "standalone" performance would be its ability to accurately measure and report compressions, which is what the bench tests on the manikin assessed. However, this is not an "algorithm-only" performance in the sense of a diagnostic or predictive AI.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • Engineering Specifications: For mechanical strength, structural integrity, low battery indication, and EMC/EMI.
  • Industry Standards/Guidelines: Specifically, the American Heart Association (AHA) recommended rate of 100 compressions/minute for simulated use on the manikin (chest displacement depth and rate, chest compression force).
  • ISO Standards: For biocompatibility (ISO 10993-1).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is described as a mechanical and electronic aid, not a machine learning or AI system that undergoes training with a "training set." Its functionality is based on pre-programmed logic for measurements and feedback, not learned from data.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set or machine learning involved. The device functions based on established engineering principles and AHA guidelines.

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