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The PARI PEP S is intended for use as a Positive Expiratory Pressure Device, and is designed to help patients exercise their lungs properly and improve secretion clearance. The PARI PEP S may be used by itself or in conjunction with aerosol drug therapy. The PARI PEP S is intended for adult and pediatric patients, for use in home, hospital, and sub-acute institutions.

The PARI PEP S is a small, single patient use, reusable PEP therapy device for use as a stand alone PEP device or for use with aerosol drug delivery. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

The provided information is for the PARI PEP S Positive Expiratory Pressure Device (K090829). This device is an Incentive Spirometer, which is a mechanical device, not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for training/test sets, ground truth establishment for AI/ML, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or provided in this 510(k) summary.

However, I will extract and present the relevant information that is available regarding its performance and the study details.

Acceptance Criteria and Device Performance:

The 510(k) summary indicates that the PARI PEP S was tested to compare its performance to predicate devices (PARI PEP and TheraPEP). The acceptance criteria are implicitly defined by "comparable to the predicate devices" for the tested parameters.

Study Details:

1. Sample size used for the test set and the data provenance: Not applicable. The testing described is a comparison of functional characteristics (resistance) rather than a clinical trial with patient data. No specific sample size for a "test set" of patient data is mentioned as clinical testing was not performed or required.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical outcomes or interpretations by experts is not relevant for this type of device comparison test.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept applies to clinical image interpretation or diagnostic performance, which is not relevant here.
4. 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: Not applicable. This is a non-AI mechanical device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a non-AI mechanical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a mechanical device performance comparison. The "ground truth" here would be the measured physical properties of the predicate devices.
7. The sample size for the training set: Not applicable. This is a non-AI mechanical device.
8. How the ground truth for the training set was established: Not applicable. This is a non-AI mechanical device.

Additional Information from the 510(k) Summary:

• Study Type: Non-Clinical Test Summary focused on comparing performance (expiratory and inspiratory resistance) of the PARI PEP S to legally marketed predicate devices (PARI PEP and TheraPEP).
• Clinical Performance Summary: "Clinical testing was not completed/is not required to show substantial equivalence." This statement confirms that clinical studies, which would typically involve patient data and clinical endpoints, were not part of this submission for substantial equivalence.
• Conclusion: "PARI PEP S meets performance requirements and raises no new issues of safety or effectiveness." This indicates that the comparative non-clinical testing was sufficient to demonstrate substantial equivalence to the predicate devices for the given indications for use.

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