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The PARI RC Cornet Mucus Clearing Device is a Positive Expiratory Pressure PEP Device and it was designed to exercise patient's lungs and to improve secretion clearance. The device was designed to work with PARI LC Nebulizers.

The PARI RC Cornet Mucus Clearing Device is a Positive Expiratory Pressure PEP Device.

I am sorry, but the provided text appears to be a 510(k) clearance letter from the FDA for a medical device (PARI RC Cornet Mucus Clearing Device). This type of document typically grants market access based on substantial equivalence to a predicate device and does not contain information about acceptance criteria or specific study data in the format you've requested.

Therefore, I cannot extract the following information from the provided text:

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

This document confirms that the device is "substantially equivalent" to a legally marketed predicate and can proceed to market, subject to general controls. It does not contain the detailed study design or performance data you are looking for, which would typically be found in the 510(k) submission itself or in a separate clinical study report.

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