SLUMBERGEAR™ headgear is an accessory to a non-continuous ventilator (respirator), intended for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and/or home environments. The headgear is reusable and for single-patient use.

Device Description

SLUMBERGEAR™ is a one-piece headgear with an integrated chinstrap used to secure externally placed masks, nasal pillows, and cannulas to the face of the patient, The headgear is a single strap that splits to wrap around the chin, the back of the head, and the top portions of the patient's head. Velcro® attached to each split portion of the headgear strap is used to fasten the headgear to the required respiratory device.

AI/ML Overview

Here's an analysis of the provided text regarding the SLUMBERGEARTM device, focusing on the acceptance criteria and the study that proves the device meets them:

The provided document is a 510(k) Summary and an FDA substantially equivalent letter for the SLUMBERGEARTM headgear. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than fulfilling specific, pre-defined acceptance criteria with quantified performance metrics. As a result, the information differs significantly from a typical detailed performance study with explicit acceptance criteria often seen for AI/software devices.

1. Table of acceptance criteria and the reported device performance

For a 510(k) submission like this, "acceptance criteria" are generally framed around demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented focuses on user satisfaction and safety/effectiveness in comparison to existing devices rather than meeting specific quantitative thresholds.

Acceptance Criteria (Implied by Substantial Equivalence for a 510(k))	Reported Device Performance
Safety: Device is safe for intended use.	"SLUMBERGEAR™ was found to be safe and effective." Differences (seamless design, closures) "add to the effectiveness and safety of the headgear."
Effectiveness: Device performs its intended function effectively.	"SLUMBERGEAR™ was found to be safe and effective." Differences "add to the effectiveness and safety of the headgear by stabilizing the respiratory device to help eliminate shifting, air escape and mouth breathing during sleep."
Intended Use Equivalence: Same intended use as predicate devices.	"the same intended use" as predicate devices (K021861 and K031047).
Technological Characteristics Equivalence: Similar operating principles, technology, materials, and manufacturing process to predicate devices, with any differences not raising new safety or effectiveness concerns.	"the same operating principles," "the same technology, same or similar materials in contact with patient's skin," "the same type of manufacturing process." Differences (one-piece design, integrated chinstrap, closure types) are stated to "add to the effectiveness and safety."
Customer Satisfaction: Acceptable comfort, stability, and convenience compared to other market headgear.	"customer satisfaction regarding comfort, stability, and convenience when compared to other headgear on the market" was determined. (Specific results are referenced as being in "Appendix A" but not provided in the excerpt.)
Substantial Equivalence Conclusion: Overall, the device is substantially equivalent to predicate devices.	"The results of the performance data show SLUMBERGEAR™ headgear is substantially equivalent to the predicate devices and other headgear previously cleared for market." "SLUMBERGEAR™ headgear is substantially equivalent to the headgear included with REMstar Pro with C-Flex CPAP System K021861 and the headgear included with Mirage Vista™ Mask K031047."

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

The document mentions that "SLUMBERGEAR™ headgear was tested to determine customer satisfaction." However, no specific sample size for this test is provided within the excerpt. The provenance of the data (e.g., country of origin, retrospective or prospective nature) 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 in this context. The "performance data" described for this device is focused on "customer satisfaction regarding comfort, stability, and convenience." This type of assessment typically involves user feedback, not expert-adjudicated ground truth in a clinical diagnostic sense. Therefore, there were no "experts" establishing a clinical ground truth for a test set in the manner of medical image analysis or similar diagnostic devices.

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

Not applicable. As the "performance data" revolves around customer satisfaction/user feedback, there is no mention or implication of a formal adjudication method by experts for a test set. The direct user experience forms the basis of the "results."

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 hardware accessory (headgear) and not an AI or software device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not relevant and was not performed.

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

No. This is a hardware accessory and not an algorithm or AI device.

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

The "ground truth" in this context is based on user feedback and reported customer satisfaction regarding comfort, stability, and convenience. The document states, "SLUMBERGEAR™ was found to be safe and effective," implying an overall positive assessment from this user testing. There is no mention of clinical outcomes data, pathology, or expert consensus serving as a ground truth for a specific medical condition's diagnosis or prognosis for this device.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model, so there is no concept of a "training set" in the context of data used to train an algorithm.

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

Not applicable. As there is no AI/ML model or training set, this question is not relevant.

Summary

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SEP 1 0 2004

S H I T E R Enterprises Inc

K042294

SLUMBERGEAR

510(k) Summary	SLUMBERGEAR Traditional 510(k) Premarket Notification
Submitter Name:	SUITER Enterprises Inc.
Submitter Mailing Address:	PO Box 567 Milton-Freewater, OR 97862
Official Contact Person:	Timothy J.S. Suiter, President 21230 SE 363 rd Street Auburn, WA 98092

Phone Number: 253-833-7418 Fax Number: 253-833-8387
E-Mail Address: SEI SLUMBERGEAR@msn.com

Date Prepared: August 8, 2004

Device Trade Name: SLUMBERGEARTM

Device Common Name/ Headgear accessory to a non-continuous ventilator/mask Classification Name: (per 21 CFR Section 868,5905)

REMstar Pro with C-Flex CPAP System K021861 Mirage Vista™ Mask K031047

Reason for Submission: New Device

Device Description:

Predicate Devices:

Intended Use:

SLUMBERGEAR™ headgear is an accessory to a non-continuous ventilator (respirator) intended for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinical, and home environments. The headgear is reusable and for single patient use.

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SLUMBERGEAR SHITTER Enternrises Inc.

Substantial Equivalence/Device Technological Characteristics and Comparison to Predicate Devices:

The SLUMBERGEAR™ headgear is intended to secure masks, nasal pillow systems, and cannulas to the patient's face. The masks, nasal pillow systems or cannulas supply positive pressure ventilation via tubing connected to a CPAP or bi-level generator.

SLUMBERGEAR™ is comprised of Velcro@ hook and loop fabric and Breath-O-Prene.™ The fabric is a smooth Lycra on the underside and Velcro® loop fabric on the outer side. The fabric has 4-way stretch and does not contain any latex material.

SLUMBERGEAR™ has the following similarities to the previously cleared predicate devices:

-the same intended use

-the same operating principles

-the same technology, same or similar materials in contact with patient's skin -the same type of manufacturing process

SLUMBERGEAR™ has the following differences to the previously cleared predicate devices: -seamless one-piece design with integrated chinstrap

-top of the head and back of the head/neck Velcro® closures

SLUMBERGEAR's™ differences add to the effectiveness and safety of the headgear by stabilizing the respiratory device to help eliminate shifting, air escape and mouth breathing during sleep. The top of the head and the back of the head/neck closures permit entering and/or exiting of the headgear while the respiratory device remains secured to the headgear. If ever necessary, the back of the head/neck closure would provide a quick efficient Emergency exit.

Performance Data:

SLUMBERGEAR™ headgear was tested to determine customer satisfaction regarding comfort, stability, and convenience when compared to other headgear on the market. SLUMBERGEAR™ was found to be safe and effective.

The results of the performance data show SLUMBERGEAR™ headgear is substantially equivalent to the predicate devices and other headgear previously cleared for market. See Appendix A for data.

There are no recognized consensus standards for headgear.

Conclusion:

SLUMBERGEAR™ headgear is substantially equivalent to the headgear included with REMstar Pro with C-Flex CPAP System K021861 and the headgear included with Mirage Vista™ Mask K031047.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with a caduceus symbol below it.

Public Health Service

SEP 1 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Timothy J.S. Suiter President Suiter Enterprises, Incorporated 21230 SE 3631d Street Auburn, Washington 98092

Re: K042294

Trade/Device Name: SLUMBERGEAR™ Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 8, 2004 Received: August 24, 2004

Dear Mr. Suiter:

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 - Mr. Suiter

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. or the rive of 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 and insting (- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 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) r mo reter notification. The FDA finding of substantial equivalence of your device to a premained we the 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), 11 you donto 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,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KO42294

Device Name: SLUMBERGEAR™

Indications for Use:

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number:	K042294

8-2

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).