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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 RMCC is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by a battery powered Control Unit. The RMCC provides consistent CPR support for cardiac arrest patients under conditions which might otherwise hinder the effectiveness of manual techniques.

• 1. Compressor Assembly: contains a motor that drives the compressor pad to depress a patient's chest.
• 2. Control Unit: contains the battery, power ON/OFF switch, Function Control Panel and umbilical power cord connecting it to the compressor assembly. Note: The battery charger is a separate unit.
• 3. Torso Restraint: is placed underneath and around the back of the patient to firmly secure the compressor assembly to the patient.
• 4. Stabilizer: serves a dual purpose; providing a head support and also attaches to the torso restraint to provide stability during continuous operation of the RMCC especially during patient transport.

The provided text describes the ROSC-U Mini Chest Compressor (RMCC), a mechanical cardiopulmonary resuscitator, and makes claims of substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria for a device's performance, nor does it describe a study that explicitly proves the device meets specific performance acceptance criteria in the manner requested.

The document summarizes the device's technological characteristics and lists non-clinical performance tests. These tests are about fundamental safety and electromagnetic compatibility standards, not specific performance metrics like compression depth accuracy, rate stability, or physiological outcomes, which would typically be included in acceptance criteria for a device like this.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only mentions the following non-clinical performance tests:

It concludes that "After performing non-clinical performance studies, the data shows that the RMCC is substantially equivalent to the predicates as an external cardiac compressor." This suggests that the studies primarily aimed to show equivalence based on safety and general functional standards rather than defined performance acceptance criteria related to its CPR efficacy.

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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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