The intended use of the modified ThAIRapy® Vest is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practice Guidelines for Postural Drainage Therapy. According to AARC guidelines, the goals of airway clearance therapy are to improve mobilization of bronchial secretions, match ventilation and perfusion, and normalize functional residual capacity. Specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with secretion clearance, or presence of atelectasis caused by mucus plugging.

Device Description

The ThAIRapy® System is a high-frequency chest wall oscillator designed be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of the ThAIRapy® System include an air oscillator and an inflatable vest. Oscillating positive pressure air pulses are applied to the vest by the air oscillator. The resulting pressure pulses cause the vest to inflate and deflate against the chest of the patient creating high-frequency chest wall oscillation and mobilization of bronchial secretions. Frequency of the pulse air is operator controlled and adjustable from 5 to 25 Hz.

AI/ML Overview

The provided document is a 510(k) summary for the ThAIRapy® System, a medical device. It describes the device, its intended use, and a comparison to a predicate device, focusing on technological characteristics and performance testing related to safety and effectiveness.

However, the document does not contain the level of detail asked for in the request regarding acceptance criteria and study particulars for a typical AI/ML device submission.

This document predates widespread AI/ML medical device submissions and focuses on demonstrating substantial equivalence to a predicate device, not on specific performance metrics against a defined ground truth using statistical methods relevant to AI/ML.

Here's a breakdown of why and what information is available:

This document does not contain the following information typically found in an AI/ML device submission:

Detailed acceptance criteria with target metrics (e.g., sensitivity, specificity, AUC).
Reported device performance against such metrics.
Sample sizes for test sets where ground truth is established for diagnostic accuracy.
Data provenance (country of origin, retrospective/prospective) for a test set.
Number of experts or their qualifications used to establish ground truth for a test set.
Adjudication method for a test set.
MRMC comparative effectiveness study results or effect sizes.
Standalone algorithm performance results.
Type of ground truth (e.g., pathology, outcomes data) for a diagnostic output.
Sample size for a training set.
How ground truth for a training set was established.

What is available and can be inferred from the document:

The submission focuses on demonstrating substantial equivalence to a predicate device (ThAIRapy® System, K884098) primarily through comparison of technological characteristics and performance testing related to the physical operation of the device, rather than diagnostic or analytical performance.

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

Acceptance Criteria: The implicit acceptance criterion is that the modified device's performance should be "consistent with the predicate" device.

Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Pressures in inflatable vests	Consistent with predicate device	"Results depict pressures that are consistent with the predicate."

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

Sample Size: Not specified. The performance testing mentions "Pressures obtained in the inflatable vests" but does not give a number of vests or tests conducted.
Data Provenance: Not specified, but likely obtained through internal testing by American Biosystems, Inc. There is no mention of external data or patient data in this context.

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

Not applicable. The performance testing here involves physical measurements (pressures) of the device, not expert interpretation of diagnostic outputs.

4. Adjudication method for the test set:

Not applicable.

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 applicable. This device is not an AI/ML diagnostic interpretation tool; it's a therapeutic physical device.

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

Not applicable.

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

The "ground truth" for the performance testing cited is the measured pressures obtained from the predicate device, against which the modified device's pressures were compared.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

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

Not applicable.

In summary, this 510(k) submission relates to a physical medical device (chest wall oscillator), not an AI/ML-driven diagnostic or treatment planning system. Therefore, the detailed requirements for AI/ML study data are not present in this document. The "study" mentioned is a direct comparison of physical performance (pressure generation) between the modified device and its predicate.

Summary

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K965192

Image /page/0/Picture/1 description: The image shows a stylized symbol that resembles a combination of the letter 'A' and a musical note. The symbol is drawn with thick, black lines, giving it a bold and graphic appearance. The overall design is abstract and could be interpreted in various ways, depending on the viewer's perspective.

ericanBiosystems

JUN 2 4 1997 01 Dec. 96

SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990.

Submitter: American Biosystems, Inc., 1375 Wolters Blvd., Suite 116, St. Paul MN 55110 (612)490-1468 Contact: Phillip R. Rose, Quality Assurance and Regulatory Affairs

Name of Device: ThAIRapy® System Classification: Powered Percussor, Class II

Predicate Device: ThAIRapy® System, K884098

Description of Device:

Intended Use:

The intended use of the ThAIRapy® System is to promote airway clearance or improve bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment. The indications typically follow the Clinical Practice Guideline published by the American Association for Respiratory Care (AARC) 1991.

Comparison of Technological Characteristics:

The modified ThAIRapy® System has been thoroughly tested to determine the impact of the changes on safety and effectiveness. All modifications have been evaluated according to categories of Electrical, Chemical, Output, Operation, and Infection Control. In all categories, the modified device remained substantially equivalent to the predicate ThAIRapy® System. The major difference to the original predicate ThAIRapy® System is the change of the air blower component to a blower from another supplier and changing generation of the air pulse oscillations from a rotary valve to utilization of reciprocating bellows. Usage of an inflatable vest with two connecting hoses continues as the same method as the original predicate for providing the external manipulation of the thorax.

Performance Testing:

Pressures obtained in the inflatable vests for the ThAIRapy® System were recorded and compared with pressures for the predicate. Results depict pressures that are consistent with the predicate.

Local 612 490 1468 American Biosystems, Inc Toll Free 800 426 4224 1375 Wolters Boulevard, Suite 116 Fax 612 490 1484 St.Paul, MN 55110

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DEPARTMENT OF HEALTH & HUMAN SERVICES

.. . ...

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Mr. Phillip R. Rose American Biosystems, Inc. 1375 Wolters Boulevard, Suite 116 St. Paul, Minnesota 55110

Re: K965192 ThAIRapy® System Regulatory Class: II (two) Product Code: 73 BYI Dated: April 4, 1997 Received: April 7, 1997

Dear Mr. Rose:

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 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, Druq, 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, labelinq, 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 regulation (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.

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Page 2 - Mr. Phillip R. Rose

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 regulation (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/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

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

Enclosure

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510(K) Number (if known),

ThAIRapy® Vest System_ Device Name___________________________________________________________________________________________________________________________________________________________________

Indications for use:

The intended use of the modified ThAIRapy® Vest is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practice Guidelines for Postural Drainage Therapy.1 According to AARC guidelines, the goals of airway clearance therapy are to improve mobilization of bronchial secretions, match ventilation and perfusion, and normalize functional residual capacity. Specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with secretion clearance, or presence of atelectasis caused by mucus plugging.

965 92

1 Bronchial Hygiene Guidelines Committee, American Association for Respiratory Care. A ARC clinical practice guideline: postural drainage therapy. Respiratory Care 1991; 36: 1418 - 1426.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard N. Phillips

(Division Sign-Off Dunsion of Cardiovasca and Neurological Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)
✓

: OR

Over The Counter Use

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).