The Total Face Mask is intended to provide a single-patient-use interface for adult patients (>30 kg) receiving Respironics CPAP or BiPAP therapy. The mask (Figure 1) fits over the entire face, with the rim of the mask framing the face along the hairline and jawline. The mask consists of a polycarbonate faceplate and a thin silicone cushion that folds inward, creating a flap on the inner perimeter of the mask to improve seal. The faceplate has four Velcro® hooks to which the headgear tabs attach.

The modified faceplate (Figure 2) is smaller, rounder, and has a streamlined profile. (Predicate mask is larger, primarily round, with the exception of the eye area, which is squared off.) Modified mask volume is smaller at 1550 ml. (Predicate volume is 2300 ml.) Modified mask cushion material is silicone. (Predicate cushion is urethane.)

Modified faceplate (Figure 2) has a nosepiece with 22-mm entrainment valve, whose accessory swivel connects to patient circuit. (Predicate faceplate has a 22-mm elbow, to which patient circuit is connected.) Entrainment valve opens to ambient air if pressure should cease. (Predicate requires use of a non-rebreathing valve (NRV).) Two built-in exhalation ports are located on the nosepiece. (Predicate's ports are located on the mask.) Nosepiece has one pressure pickoff port. (Predicate elbow has two.) The headgear consists of Velcro® straps. (Predicate headgear is a cap with Velcro straps.)

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modified Respironics® Total™ Face Mask. While it mentions that "Design verification tests were performed... and acceptance criteria were met," it does not provide any specific details about the acceptance criteria themselves or the results of these tests.

Therefore, I cannot populate the table with acceptance criteria and reported device performance, nor can I answer many of the other questions regarding the study design, sample sizes, ground truth, or expert involvement. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on similar intended use, operating principle, technology, and manufacturing process.

Here's what information can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document states "Design verification tests were performed" but provides no details on the number of units tested or patients involved.
Data Provenance: Not specified. It's likely the tests were conducted by Respironics, Inc. in Murrysville, PA, USA, given the contact information, but this is an inference, not explicitly stated. The nature (retrospective/prospective) is also not specified.

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. The document does not describe the establishment of a "ground truth" using human experts in the context of diagnostic performance, but rather design verification tests.

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

Not applicable. No expert adjudication process is described for design verification tests.

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. This is a medical device for respiratory support, not an AI-powered diagnostic tool. An MRMC study is not relevant to this submission.

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

Not applicable. This is a physical medical device (mask), not an algorithm.

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

Not explicitly stated. For "design verification tests," the ground truth would typically be engineering specifications, performance standards (e.g., seal integrity, pressure drop, material biocompatibility, volume), or functional requirements. The document mentions compliance with "applicable standards referenced in the 'Draft FDA Reviewer Guidance for Premarket Notifications,' November 1993," which would presumably define some of these criteria.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

In summary, the provided text is a 510(k) summary for a modified medical device, not a detailed scientific study report on performance metrics as would be expected for a diagnostic AI device. It confirms that design verification tests were performed and met acceptance criteria, but does not elaborate on what those criteria or results were.

Summary

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TACHMENT 4

SUMMARY OF SAFETY & EFFE

Official Contact	David J. VanellaManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668
Classification Reference	21 CFR 868.5905
Product Code	BZD - noncontinuous ventilator
Common/Usual Name	nasal mask
Proprietary Name	Respironics® Total™ Face Mask
Predicate Device	Total Face Mask (K925920)
Reason for submission	Modified design; modified materials

Substantial Equivalence

The modified mask has the following similarities to the previously cleared predicate device:

0 Same intended use.
ପ Same operating principle.
Same technology.
O Same manufacturing process.

Design verification tests were performed on the Total Face Mask as a result of the risk analysis assessment, and acceptance criteria were met. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the mask described in this submission is substantially equivalent to the predicate device.

The modified mask complies with the applicable standards referenced in the "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993.

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Device Description/Intended Use

Image /page/1/Figure/4 description: The image contains two figures of a Respironics Total Face Mask. Figure 1 shows the face mask being worn with headgear and flexible tubing. Figure 2 shows the face mask with the total face mask faceplate, entrainment valve, accessory swivel, exhalation ports, pressure pickoff port cap, and headgear hooks.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 1999

Mr. David J. Vanella Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668-8550

K992969 Re : Total Face Mask Regulatory Class: II (two) Product Code: 73 BZD October 8, 1999 Dated: Received: October 12, 1999

Dear Mr. Vanella:

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 requlations 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. David J. Vanella

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/dsma/dsmamain.html".

Sincerely yours,

Jeanne M. Wentworth for;

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

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510(k) Number (if known): K992969

Device Name: Respironics® Total™ Face Mask

Intended Use/Indications for Use

The Respironics® Total™ Face Mask is intended to provide an interface for application of Respironics CPAP or BiPAP therapy to patients.

Environment of Use/Patient Population

For single patient use in the home or hospital/institutional environment. The mask is to be used on adult patients (>30 kg) for whom CPAP or BiPAP therapy has been prescribed using a Respironics CPAP or BiPAP system.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
------------------------------------------	----	--------------------------------------------------

(Division Sign-Off)
Division of Cardiovascular, Respiratory,and Neurological Devices
510(k) Number	K 992969

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).