The Invacare Model Twilight Nasal CPAP Mask is intended to be used with positive airway pressure devices such as CPAP, to provide 3-20 cmH2O for the treatment of adult obstructive sleep apnea. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single patient use.

Device Description

The Twilight nasal mask is a prescription device intended for use with Continuous Positive Airway Pressure (CPAP), and Bi-Level devices. It is intended to provide a single patient use interface for the delivery of CPAP or Bi-Level therapy to adult patients (>30Kg). It is designed for use with CPAP and Bi-Level delivery systems having pressure ranges from 3-20 cmH2O.

The Twilight nasal mask consists of a mask that fits over the nose of the patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose. A standard and a large cushion are designed for use with the same mask. This also allows for replacement of a worn or damaged cushion without the need to replace the entire mask. The cushion mounts into a rigid polycarbonate shell by means of a flanged area that fits snugly between the wall of the mask shell and an inner retaining ring that is permanently mounted into the shell.

The mask includes an opening that accepts a standard, flexible, 22cm OD breathing tube. The breathing tube is connected to the output of the CPAP/Bi-Level delivery device, and to the input of the Invacare Twilight Nasal Mask. The mask is then placed over the users' nose and mouth. The flexible tube provides a transition between the more rigid output tube of the delivery device, and the mask, thus allowing freedom of movement while maintaining patient circuit integrity.

AI/ML Overview

The provided text describes a 510(k) submission for the Invacare Model Twilight Nasal Mask. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics described in typical AI/ML medical device studies.

Therefore, much of the requested information (acceptance criteria, performance tables, sample sizes for test/training sets, expert qualifications, ground truth methodology, MRMC studies, standalone performance) is not applicable or not provided in the context of this 510(k) summary.

Here's a breakdown of what can be extracted and what is not available:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The "acceptance criteria" for a 510(k) submission are typically related to demonstrating substantial equivalence through comparison of technological characteristics and performance data to predicate devices.
Reported Device Performance: The document states:

"A number tests were conducted on the Invacare Model Twilight Nasal Mask. In all cases the mask performed as designed and intended."
This is a general statement and does not provide specific performance metrics (e.g., leak rate, comfort scores, efficacy in treating OSA) that would typically be found in a clinical study report. It implies that the engineering and design validation tests were successful.

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. The document mentions "a number tests" but does not specify the type of tests (e.g., patient trials, bench testing), the number of subjects/samples, or the nature of the data (prospective, retrospective, country of origin).

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 Applicable / Not Available. This device is a physical medical device (nasal mask) for CPAP therapy, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for its performance evaluation in the way imaging algorithms do. Performance testing likely involved engineering validation and possibly limited human factors testing, but not "ground truth" establishment by experts in the sense of image interpretation.

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

Not Applicable / Not Available. As above, this concept (adjudication of expert readings) does not apply to the type of performance evaluation described for a CPAP nasal mask in a 510(k) 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

No. An MRMC study is relevant for AI-assisted diagnostic or interpretive tasks. This device is a CPAP nasal mask and does not involve "human readers" or "AI assistance" in that context.

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 consensus, pathology, outcomes data, etc.)

Not Applicable. See points 3 and 4. The performance of a nasal mask is evaluated based on its physical properties, comfort, seal, and ability to deliver prescribed pressure, as demonstrated through engineering tests and potentially user feedback, rather than against a medical "ground truth" for diagnosis.

8. The sample size for the training set

Not Applicable / Not Available. This device is not an AI/ML model; therefore, there is no "training set" in the computational sense.

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

Not Applicable. This device is not an AI/ML model.

Summary

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FEB 1 1 2003

KC22642

510(k) SUMMARY (Revised December 16, 2002)

Invacare Corporation's Model Twilight Nasal Mask

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Contact Person:

Rae Ann Farrow Manager, Regulatory Compliance

Date Prepared: August 7, 2002

Name of Device and Name/Address of Sponsor

Invacare Model Twilight Nasal Mask

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Common or Usual Name CPAP Mask

Classification Name Ventilator, Non-continuous

Predicate Devices

Resmed Corporation Mirage Nasal Mask (K982530), and the Sleepnet Corporation Model IQ™ Nasal Mask (K993269).

Intended Use

The Invacare Model Twilight Nasal CPAP Mask is intended to be used with positive airway pressure devices such as CPAP, to provide 3-20 cmHzO for the treatment of adult obstructive sleep apnea. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single patient use.

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Technological Characteristics and Substantial Equivalence

A. Device Description

B. Substantial Equivalence

The Invacare Model Twilight Nasal Mask covered by this submission is substantially equivalent to the other devices currently being marketed in the United States that have been granted marketing clearance by FDA. Specifically, the Twilight Mask is substantially equivalent to the Resmed Corporation Mirage Nasal Mask (K982530), and the Sleepnet Corporation Model IQ™ Nasal Mask (K993269).

Performance Data

A number tests were conducted on the Invacare Model Twilight Nasal Mask. In all cases the mask performed as designed and intended.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

FEB 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rae Ann Farrow Manager, Regulatory Compliance Invacare Corporation One Invacare Way Elyria, Ohio 44036

Re: K022642

Trade/Device Name: Invacare's Model ISP9600 Twilight Nasal Mask Regulation Number: 868.5905 Regulation Name: Non-continuous Ventilator Regulatory Class: II Product Code: BZD Dated: November 12, 2002 Received: November 14, 2002

Dear Ms. Farrow:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Farrow

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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.

Susan Runrer

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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10(k) Number (if known): K022642

Device Name: Invacare's Model ISP9600 Twilight Nasal Mask

Indications For Use:

The Invacare Model Twilight Nasal CPAP Mask is intended to be used with positive airway pressure devices such as CPAP, to provide 3-20 cmH2O for the treatment of adult obstructive sleep The mask is to be used on adult patients (>30 kg) for whom positive airway pressure apnea. therapy has been prescribed. The mask is intended for single patient use.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	V
(Per 21 CFR 801.109)

Over-The-Counter Use

sion Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devi-

510(k) Number ..

(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).