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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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The PARI PEP Device is an Expiratory Resistance Exerciser and ii was designed to help patients exercise their lungs properly, improve secretion clearance. This expiratory resistance exerciser will be used with patients for whom a physician has prescribed lung exercise treatments at home. doctor's office, hospitals and clinics.

The PARI PEP Device is an Expiratory Resistance Exerciser. The PARI PEP was designed to work with the PARI Nebulizers.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance metrics, or details of a study with a test set, training set, or expert involvement to establish ground truth. The document is an FDA letter regarding the substantial equivalence of the PARI PEP® Positive Expiratory Pressure Therapy System, which primarily discusses regulatory classification and marketing authorization. It does not include a technical or clinical study summary.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device