The CPAP/PRO® CPAP Interface consists of a boil & bite type dental appliance or a bracket, which may be professionally fitted to a custom dental appliance. With either mouth appliance, a small bracket extends beyond the lips to attach to a pair of corrugated nasal tubes. The paired nasal tubes are made from corrugated polyethylene and are pressure tested. The paired tubes combine to form a "Y", The lower arm of which attaches to a CPAP machine using a fitting connected to standard respirator tubing. The upper arms of the "Y" shaped nasel tubes terminate in soft silicone nasal inserts. The inserts provide a soft, comfortable seal against the nostrils.

The CPAP/PRO® consists of the following major components:

Boil & bite molded dental appliance with integral tubing clamp.
CPAP/PRO® tubing clamp for use with professionally fitted dental appliance.
Polycarbonate dual lumen respiratory tubing connector.
Corrugated 15mm (nominal diameter) polyethylene tubing with 1/8m " vent holes.
Silicone elastomer nasal inserts.
Dual lumen (polycarbonate) tubing/appliance bracket .

AI/ML Overview

The provided document, K992384, is a 510(k) Premarket Notification for the CPAP/PRO® CPAP Interface. It details the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Summary from Section 7)
Functional equivalence in terms of airflow to predicate devices.	Comparative testing demonstrated that, in terms of airflow, the CPAP/PRO® is the functional equivalent of "SoftNair™ by Vital Signs, Inc." and "Adam CPAP Circuit by Nellcor Puritan-Bennett."
Functional equivalence in terms of dead-space to predicate devices.	Comparative testing demonstrated that, in terms of dead-space, the CPAP/PRO® is the functional equivalent of "SoftNair™ by Vital Signs, Inc." and "Adam CPAP Circuit by Nellcor Puritan-Bennett."
Materials are safe and suitable for intended use.	Implied by the declaration in Section 10: "Based on the materials...the CPAP/PRO unit is equivalent to the referenced legally marketed comparison devices." (No specific criteria outlined, but general safety/suitability is a core regulatory requirement)
Design is safe and effective for intended use.	Implied by the declaration in Section 10: "Based on the...design...the CPAP/PRO unit is equivalent to the referenced legally marketed comparison devices." (No specific criteria outlined)
Intended use (treatment of adult obstructive sleep apnea (OSA)) is met.	Indication for Use: "The CPAP/PRO® CPAP Interface is intended to treat adult obstructive sleep apnea(OSA)." The FDA's substantial equivalence finding supports this.

Important Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria. The acceptance criteria are therefore inferred from regulatory requirements for a 510(k) submission, which hinge on similarity to already approved devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any "test set" in the context of clinical trials or performance evaluations with human subjects. The comparative testing mentioned in Section 7 (airflow and dead-space) likely refers to bench testing or engineering testing comparing the physical properties of the CPAP/PRO® with the predicate devices.

Sample Size for Test Set: Not specified, and likely not applicable in the sense of human subject clinical data.
Data Provenance: Not specified, but given the nature of the comparative testing, it would be laboratory-based rather than from a specific country or clinical setting. It is not labelled as retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for the comparative testing (airflow and dead-space) would be based on established engineering or physiological standards and measurement techniques, not typically "expert consensus" in the clinical sense.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the type of testing described (bench/engineering comparison). Adjudication methods like 2+1 or 3+1 are typically used for clinical trials or image interpretation studies to resolve discrepancies among expert readers.

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

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done, nor is it applicable to this device. This device is a physical CPAP interface, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no mention of human readers improving with or without "AI assistance" and no "effect size" information.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

A standalone performance study was not done in the context of an algorithm. The device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the comparative testing (airflow and dead-space) would be based on objective physical measurements using scientific instruments and established protocols, comparing the CPAP/PRO® against the known performance characteristics of the predicate devices. It is not based on expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable to this device. "Training set" typically refers to data used to train machine learning models, which are not involved here.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable to this device as there is no training set for a machine learning model.

Summary

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

K992384

d Premarket Notification

nary of Safety and Effectiveness Information

Requiatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name:

TRADE NAME;	CPAP/PRO CPAP Interface
COMMON NAME:	CPAP
CLASSIFICATION NAME:	Noncontinuous ventilator

2. Establishment Name & Registration Number: Name: STEVENSON INDUSTRIES, INC. Number: Pending

3. Classification:

$ 868,5905 (IPPB). (a) Identification. A noncontinuous ventilator (internittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing. (b) Classification. Class it (performance standards). Product Code(s): 73BZD & FORMA Device Class: Class II & undersified

Anesthesia Devices Panel & Deatst Boxice Panel, respectively Classification Panel;

ব Contact Person:

Mr. Joseph L. Goldstein STEVENSON INDUSTRIES, INC. 1515 Palisades Dr., Suite M Pacific Palisades, CA 90272-9906 310.459.9393 - 310.459.1575 FAX

Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 925,356,2640 / 925,356,2654 FAX

6. Description of the Device;

The CPAP/PRO® consists of the following major components:

1. Boil & bite molded dental appliance with integral tubing clamp.
र्ष CPAP/PRO® tubing clamp for use with professionally fitted dental appliance.
ల Polycarbonate dual lumen respiratory tubing connector.
1. Corrugated 15mm (nominal diameter) polyethylene tubing with 1/8m " vent holes.
റ് Silicone elastomer nasal inserts.
1. Dual lumen (polycarbonate) tubing/appliance bracket .

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

7. Comparison to Predicate Device(s):

CPAP/PRO® CPAP Interface may be directly contrasted with the following equivalent devices:

SoftNair™ by Vital Signs, Inc. ﮩ
1. Adam CPAP Circuit by Nellcor Puritan-Bennett

The SoftNair™ and Adam CPAP Circuit are the most like the CPAP/PRO® in terms of design, materials and method of use. Comparative testing has been conducted and demonstrates that, in terms of airflow and dead-space, the CPAP/PRO® is the functional equivalent of both devices.

8. Packaging:

Plastic bags, peel pouches, and clear tubes are used to contain the individual device components. The packaging selected for use is sufficient to identify, protect and transport the devices safely. Shipper materials are standard, paper fiber industry typical bulk box-type shipper packaging.

9. Sterilization/Re-sterilization:

The device and its components are packaged in "clean only" condition but are free of manufacturing debris and residue. Each component is inspected after processing to evaluate and document the removal of manufacturing residue and debris. However, it is recommended the device be removed from it's shipping and packing materials, washed and rinsed thoroughly before use.

10. Conclusion:

Based on the materials, intended uses, design, comparison testing, long standing safe and effective use of the CPAP nasal interface, the CPAP/PRO unit is equivalent to the referenced legally marketed comparison devices.

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three stripes above it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 1999

Mr. David W. Schlerf Stevenson Industries, Inc. c/o Buckman Company Incorporated 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389

Re: K992384 CPAP/PRO® CPAP Interface Requlatory Class: II (two) Product Code: 73 BZD September 14, 1999 Dated: September 16, 1999 Received:

Dear Mr. Schlerf:

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 legally 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 Failure to comply with the GMP regulation may result in assumptions. requlatory 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.

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

Page 2 - Mr. David W. Schlerf

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,

Carole C. Carey

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

K992384 510(k) Number:

CPAP/PRO® CPAP Interface Device Name: CPAP/PRO® Antisnoring Device

Indications For Use:

The CPAP/PRO® CPAP Interface is intended to treat adult obstructive sleep apnea(OSA).

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Firston of Cardion Respiratory and Neurological D 510(k) Number Prescription Use OR Over-The-Counter Use _ (Per 21 CFR 801.109) (Optional format 1-2-96)

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).