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The X-Air-Ciser is a Positive Expiratory Pressure (PEP) device, Inspiratory Muscle Trainer (IMT) and Percussor all in one device. The X-Air-Ciser can also function as a percussor, that may be helpful loosening and removing mucus.

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The provide text is a 510(k) summary and an FDA clearance letter for a medical device called the X-Air-Ciser. This document does not contain acceptance criteria or a study that proves the device meets those criteria. Instead, it aims to demonstrate substantial equivalence to a predicate device already on the market, usually through comparison of technological characteristics and intended use, rather than through a performance study against predefined acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be gathered:

1. A table of acceptance criteria and the reported device performance

• Not Available. The provided document is a 510(k) submission summary for substantial equivalence, not a performance study report with acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available. No test set or data provenance details are provided as this is not a clinical study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Available. Ground truth establishment is not relevant to this type of submission.

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

• Not Available. Adjudication methods are not relevant to this type of submission.

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

• Not Available. This device is a mechanical device (PEP device/Inspiratory Muscle Trainer/Percussor), not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. Ground truth is not established in this type of submission.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not Applicable. As above, not a machine learning model.

Information that is available about the device and its clearance:

• Device Name: X-Air-Ciser®
• Classification Name: (PEP) Device/Inspiratory Muscle Trainer
• Common/Usual Name: (PEP) Device/Inspiratory Muscle Trainer
• Predicate Device: Breather (K944412)
• Intended Uses: (PEP) Positive Expiratory Pressure, (IMT) Inspiration Muscle Trainer, and can also function as a percussor to help loosen and remove mucus.
• Patient Population: Adult & Children
• Use Type: Single patient use and reusable.
• Regulatory Class: II (two)
• Product Code: 73 BYI
• Submission Type: 510(k) Pre-market Notification, cleared based on substantial equivalence to the predicate device.

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