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The device is for use as a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device, for use by adults and children. The device is for single patient use, not for use on multiple patients.

The breathing trainer includes an inner chamber, an outer chamber, a breathing tube, and a perforated bottom cap to the inner chamber. Four teaspoons of water (20 ml.) are placed in the outer chamber and the patient breaths in and out of the breathing tube. The training effect is caused by the added pressure of the water. US Patent Number 5,755,640.

The Frolov's Respiration Training Device, FRTD-01, is a breathing training device intended for use as a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT).

1. Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria for the Frolov's Respiration Training Device, FRTD-01. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device, the Mini-Ciser (K974848).

Therefore, the reported device performance is implicitly that it is "as safe and effective as the predicate device," meaning it functions comparably in its intended use as a PEP and IMT device. Without specific performance metrics for the predicate device within this document, we cannot provide quantitative values for FRTD-01's performance.

2. Sample size used for the test set and the data provenance:

The document mentions "bench and user testing" but does not specify the sample size for either the bench testing or the user testing. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the supplied documentation. The study appears to focus on comparative effectiveness to a predicate device rather than establishing a new "ground truth" for the a medical condition using expert review.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the supplied documentation.

5. 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:

This is not applicable as the device is a mechanical breathing trainer and not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable as the device is a mechanical breathing trainer and does not involve an algorithm. The "user testing" would inherently involve human users.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Given the nature of the device (a breathing trainer) and the lack of specific clinical trial data, the "ground truth" for its effectiveness and safety would likely be established through:

• Bench testing: Verifying the physical and functional specifications of the device (e.g., pressure output, air resistance).
• User testing: Assessing patient comfort, ease of use, and potentially physiological responses consistent with PEP and IMT, as compared to the predicate device.
• Comparison to predicate device: The primary "truth" is that its performance matches that of the legally marketed predicate device, which would have had its own "ground truth" established during its clearance process.

8. The sample size for the training set:

This information is not provided. It's important to note that for a mechanical device, the concept of a "training set" in the context of machine learning is not directly applicable. If "training set" refers to data used to refine the device's design, that is not detailed.

9. How the ground truth for the training set was established:

Not applicable in the context of device design and development as described in this 510(k) summary. The "ground truth" for guiding the design process would be engineering specifications, existing scientific understanding of respiratory physiology, and performance data from the predicate device.

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