PillowPositive Cervical Pillow ("PillowPositive") is intended for the reduction of symptoms (apnea/hypopnea) associated with mild obstructive sleep apnea by maintaining an open upper airway during sleep.

PillowPositive Cervical Pillow ("PillowPositive") is indicated for the reduction of symptoms (apneas and hypopneas) associated with mild obstructive sleep apnea.

Device Description

The pillow consists of a custom-fitted high resiliency urethane foundation, an overlying "memory foam" supporting the head and neck, a stretch terry-cloth cover, and removable foam inserts. The PillowPositive is comprised of a thin central area for supine sleeping and two thicker, sloped side panels with earwells for side sleeping.

AI/ML Overview

The provided text describes the regulatory clearance for the "PillowPositive Cervical Pillow" and includes a summary of performance data from a pilot study and a pivotal study. However, it does not explicitly define acceptance criteria as a table with specific metrics or detail the study methodology with the granularity requested in the prompt.

Based on the provided text, here's an attempt to extract and infer the information:

1. Table of acceptance criteria and reported device performance:

The document states that the PillowPositive reduces the Respiratory Disturbance Index (RDI), which is defined as apneas and hypopneas, in subjects with mild obstructive sleep apnea. It also mentions "statistically significant reduction." However, it does not provide specific numerical thresholds or target values for this reduction to constitute "acceptance criteria."

Acceptance Criteria (Implied)	Reported Device Performance
Reduction in Respiratory Disturbance Index (RDI)	Pivotal Study: Produces a statistically significant reduction in RDI.
(No specific quantitative target or lower bound for reduction)	Pilot Study: Showed a statistically significant reduction in RDI.
Safety and Effectiveness (Relative to predicates)	No new issues of safety and effectiveness compared to predicate devices.
Similar intended use, principles of operation, and technological characteristics to predicate devices	Has the same intended use as Dr. Jonathan A. Parker's PM Positioner and Adjustable PM Positioner. Similar principles of operation to PM Positioner, Adjustable PM Positioner, and A-Just Right Pillow. Similar technological features to Ortho-Rest Company's A-Just Right Pillow. Minor differences present no new issues of safety and effectiveness.

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

Test Set Sample Size: Not explicitly stated for either the pilot or pivotal study.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they were conducted "to assess the PillowPositive's use."

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

This information is not provided in the document. The studies assess the product's effect on RDI, which is typically measured by polysomnography, but the details of who interpreted these studies are not mentioned.

4. Adjudication method for the test set:

This information is not provided in the document.

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:

This is not applicable to this device. The PillowPositive Cervical Pillow is a physical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.

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

This is not applicable as the PillowPositive is a physical medical device and not an algorithm.

7. The type of ground truth used:

The "ground truth" for evaluating the device's performance appears to be the Respiratory Disturbance Index (RDI), which is an objective physiological measure obtained through sleep studies (polysomnography).

8. The sample size for the training set:

There is no mention of a training set as this is a physical medical device undergoing clinical studies, not an AI algorithm.

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

This question is not applicable as there is no training set mentioned in the context of this device.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2004

Life Sleep Systems, Inc. c/o Mr. Howard M. Holstein Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109

Re: K990871

Trade/Device Name: PillowPositive Cervical Pillow Regulation Number: 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: MYB Dated: March 16, 1999 Received: March 16, 1999

Dear Mr. Holstein:

This letter corrects our substantially equivalent letter of June 10, 1999 regarding the PillowPositive regulatory classification. At the time of that letter. FDA incorrectly classified the Cervical Pillow, as indicated, as an unclassified device. This device is classified under 872.5570, Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. The product code will remain as MYB.

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 (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 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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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 (QS) 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 continue 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 (240) 276-0115. 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 vours.

A. Joseph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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JUN 1 0 1999

(990871

510(K) SUMMARY FOR LIFESLEEP SYSTEMS, INC.'S PILLOWPOSITIVE

Submitter's Name, Address, Telephone Number, and Contact Person

LifeSleep Systems, Inc. 400 Oyster Point Boulevard Suite 112 South San Francisco, California 94080

Contact:	Anthony A. DiTonno
	President & Chief Executive Officer
	LifeSleep Systems, Inc.
Phone:	(650) 616-9933 / (650) 616-1005
Facsimile:	(650) 616-9930

Date Prepared

March 16, 1999

Name of the Device

LifeSleep PillowPositive Cervical Pillow

Common or Usual Name

Cervical Pillow

Classification Name

Truncal Orthosis

Product Code

IQK

Predicate Devices

Lifesleep System's Pillow
Positive Cervical Pillow

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(4) Ortho-Rest Company's A-Just Right Pillow

Intended Use

Principles of Operation

The PillowPositive places and holds the head and neck in a position that is similar to that used in cardiopulmonary resuscitation, the upper airway remains open, thereby reducing the incidence of mild obstructive sleep apnea.

Technological Characteristics

Performance Data

LifeSleep sponsored a pilot study and a pivotal study to assess the PillowPositive's use in the reduction of symptoms associated with mild obstructive sleep apnea. The pilot study showed a statistically significant reduction in the Respiratory Disturbance Index (i.e., apneas and hypopneas) among subject with mild obstructive sleep apnea. The pivotal study indicated that the PillowPositive produces a statistically significant reduction in subject's Respiratory Disturbance Index, a key indicator of sleep apnea, in subjects with mild sleep apnea.

Summary of the Basis for the Finding of Substantial Equivalence

The LifeSleep PillowPositive for the reduction of the symptoms associated with mild obstructive sleep apnea has the same intended use as the Dr. Jonathan A. Parker's PM Positioner, and Adjustable PM Positioner. The Pillow Positive for the reduction of symptoms associated with mild sleep apnea has similar principles or operation as the PM Positioner, the Adjustable PM Positioner, and the A-Just Right Pillow. The PillowPositive for the reduction of symptoms associated with mild obstructive sleep apnea has the same technological characteristics as the legally marketed PillowPositive for snoring and very similar technological features as Ortho-Rest Company's A-Just Right Pillow. The minor differences between the intended use and

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the technological characteristics of LifeSleep's PillowPositive for the reduction of symptoms associated with mild obstructive sleep apnea and its predicate devices present no new issues of safety and effectiveness. Moreover, the clinical data demonstrate that the device reduces the symptoms (apneas/hypopneas) associated with mild obstructive sleep apnea. Therefore, the LifeSleep PillowPositive for the reduction of symptoms associated with mild obstructive sleep apnea is substantially equivalent to its legally marketed predicate devices.

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: LifeSleep Systems, Inc. PillowPositive Cervical Pillow

Indications for Use:

PillowPositive Cervical Pillow ("PillowPositive") is indicated for the reduction of symptoms (apneas and hypopneas) associated with mild obstructive sleep apnea.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number	K990871
	6/9/99

Prescription Use __ (Per 21 C.F.R. 801.109)

OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”