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To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

The miniaturized compressor (MCC) is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by compressed oxygen or air.

The MCC provides consistent CPR support for cardiac arrest patients under conditions, which might otherwise hinder the effectiveness of manual techniques.

Here's an analysis of the provided text to extract the acceptance criteria and details of the supporting study:

The provided document describes a mechanical chest compressor (MCC) and its premarket notification, not an AI/algorithm-based device. Therefore, many of the requested fields related to AI performance, human-in-the-loop, training sets, and expert adjudication are not applicable or cannot be determined from the given text.

The primary study mentioned is a non-clinical animal study comparing the MCC to a predicate device.

Here's the breakdown based on the provided information, indicating when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size (Test Set): Not explicitly stated for either bench testing or animal testing. The animal study mentions "animal testing" but doesn't specify the number of animals.
• Data Provenance:
  • Bench Testing: Simulated cardiopulmonary resuscitation (simulated environment).
  • Animal Testing: Animal models (type of animal not specified).

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

• Not Applicable. The device is a mechanical chest compressor, not an imaging or diagnostic AI device requiring expert ground truth for a test set. The validation relies on objective physical measurements and biological outcomes in animals.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication of results is mentioned for the mechanical device performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI-assisted device.

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

• Not Applicable. This is a mechanical device, not an algorithm. Bench testing evaluated its standalone mechanical performance.

7. The Type of Ground Truth Used

• For Bench Testing: "Recommended by the CPR guidelines" implies a standard for mechanical compression parameters (e.g., depth, rate) as ground truth.
• For Animal Testing: "CPR efficacy and ultimately on outcomes after prolonged cardiac arrest" suggests physiological outcomes (e.g., return of spontaneous circulation, survival metrics) were used as "ground truth" to determine effectiveness.

8. The Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not an AI model that requires a training set.

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

• Not Applicable. This is a mechanical device, not an AI model that requires a training set.

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