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

{0}------------------------------------------------

ic9 4849

Province Comment

6 1998 AUG

ກະລັດຖະກຳລັງທີ່ 2004 ເດີຍ 2001 ເປັນ 2001 ເປັນ 200

510 (k) SUMMARY

Date:	April 29, 1998
Contact Person:	Jeffery R. Miller
Classification Name:	(PEP) Device/Inspiratory Muscle Trainer
Common/Usual Name:	(PEP) Device/Inspiratory Muscle Trainer
Proprietary Name:	X-Air-Ciser®
Claiming Equivalence To:	Breather (K944412)
Intended Uses:	(PEP) Positive Expiratory Pressure(IMT) Inspiration Muscle Trainer

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 6 1998

Mr. Jeffery R. Miller Hougen MFG., Inc. 3001 Hougen Drive Swartz Creek, MI 48473

K974849 Re: X-AIR-CISER Regulatory Class: II (two) Product Code: 73 BYI Dated: May 12, 1998 Received: May 15, 1998

Dear Mr. Miller:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 - Mr. Jeffery R. Miller

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Collellon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

STATEMENT OF INDICATIONS

X-AIR-CISER

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.

Patient population: Adult & Children,

Single patient use and reusable.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Prescription Use

llame

q74849

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

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).