X-AIR-CISER by HOUGEN MFG., INC.

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.

Device Description

Not Found

AI/ML Overview

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.

Summary

Regulation Number and Section

§ 868.5665 Powered percussor.

(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).