The Sleep-In™ Bone Screw System is intended for anterior advancement and suspension of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of obstructive sleep apnea ("OSA") and/or snoring.

Device Description

The Sleep-In™ Bone Screw System consists of three main components: a bone screw attached to surgical suture material, a bone screw inserter, and a suture passer. The Sleep-In™ Bone Screw is a sharp tipped, small diameter titanium screw with polypropylene monofilament no. 1 suture crimped into its base. The Sleep-In™ Bone Screw Inserter is a disposable, battery operated, single use device. The Sleep-In™ Suture Passer is designed to assist in passing the suture through the floor of the tongue during the Sleep-In™ procedure.

AI/ML Overview

This document describes a medical device, the Sleep-In™ Bone Screw System, and its regulatory submission. It does not contain information about studies proving the device meets specific acceptance criteria in the manner a diagnostic or AI-powered device would. The information provided is for a traditional medical device (bone screw system), which typically relies on compliance with pre-established mechanical and material standards rather than performance metrics like sensitivity, specificity, or reader studies.

Therefore, many of the requested fields are not applicable to the provided text.

Here's a breakdown of what can be extracted and why other fields are not relevant:

Acceptance Criteria and Device Performance (Not Applicable - See Explanation Below)

This section is not applicable because the document describes a mechanical fixation device, not a diagnostic or AI system with performance metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" for such a device are primarily related to material properties and mechanical integrity, rather than a "reported device performance" in terms of diagnostic effectiveness.

The document states: "No performance standards applicable to the bone screw systems have been established by the FDA. However, the titanium alloy 6AL-4V Eli alloy used to manufacture the Sleep-In™ Bone Screw meets the chemical and mechanical requirements in voluntary standards established by ASTM (F136-84)." This indicates material compliance rather than performance criteria in the sense of a diagnostic device.

Study Information (Where Applicable):

Sample size used for the test set and the data provenance: Not applicable. The document mentions "initial clinical experience" but does not detail a specific test set or its size for performance evaluation. The provenance of this clinical experience is not specified (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment with experts is typical for diagnostic or AI evaluation, not for a bone screw system.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a bone screw system.
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: Not applicable. This type of study is for evaluating AI-assisted diagnostic tools, not mechanical devices.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly defined in terms of a "ground truth" for performance. For a mechanical device, successful implantation and clinical outcome (e.g., reduction in OSA/snoring symptoms) would be relevant, but specific methods for establishing a "ground truth" in this context are not detailed. The document mentions "initial clinical experience," which implies some form of outcomes data.
The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical structure for AI/diagnostic device evaluation, it does provide some critical information about the device's validation:

Performance Standards Mentioned:
- No FDA-established performance standards for bone screw systems.
- The titanium alloy (6AL-4V Eli) used in the Sleep-In™ Bone Screw meets chemical and mechanical requirements of ASTM (F136-84). This acts as the material acceptance criterion.
Studies Mentioned:
- "The performance characteristics of the Sleep-In™ Bone Screw System has been tested and approved through a series of in vitro and in vivo studies." (Details of these studies, including sample sizes or specific acceptance criteria for these studies, are not provided in this excerpt.)
- "Furthermore, initial clinical experience with the Sleep-In™ Bone Screw System has demonstrated its potential for treating patients suffering from OSA and/or snoring." (No specifics on size or results of this experience are given.)
Substantial Equivalence Basis: The device's technological characteristics and intended use are deemed substantially equivalent to predicate devices based on:
- Suspension of soft tissue to fixed bone by sutures attached to bone screws (similar to In-Fast™ Bone Screw System and Mitek GII Anchor).
- Procedure based on accepted methods like Hyoid Bone Suspension, Chin Osteotomy, and Mandibular Advancement.
- Repositioning of the tongue for OSA/snoring treatment (similar to PM Positioner™ and Snor-X Mouthguard).

In conclusion, this document primarily focuses on regulatory submission and substantial equivalence for a mechanical medical device, rather than providing detailed "acceptance criteria" and "study results" in the context of diagnostic performance or AI evaluation.

Summary

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510(k) Summary

Influence, Inc.'s Sleep-In™ Bone Screw System

Company Name:

Influence, Inc. 601 Montgomery Street, Suite 845 San Francisco, California 94111

Submitter's Name and Contact Person:

Peter Bick, M.D., President and CEO Influence, Inc. 601 Montgomery Street, Suite 845 San Francisco, California 94111 Telephone: 415-421-5600 Fax: 415-421-5622

Date Prepared:

May 29, 1997

Trade/Proprietary Name:

Sleep-In™ Bone Screw System

Classification Name:

The Sleep-In™ Bone Screw System has not yet been classified.

Predicate Devices:

Sleep-In™ Bone Screw and Sleep-In™ Bone Inserter:

· In-Fast™ Bone Screw System (K970292)
· Mitek GII Anchor (K920213)
· PM Positioner™ (K953293 & K955503)
· Snor-X Mouthguard (K954324)

Sleep-In™ Suture Passer:

· Protecta-Pass™ Suture Passer (K932925)

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Performance Standards:

No performance standards applicable to the bone screw systems have been established by the FDA. However, the titanium alloy 6AL-4V Eli alloy used to manufacture the Sleep-In™ Bone Screw meets the chemical and mechanical requirements in voluntary standards established by ASTM (F136-84).

Intended Use:

System Description:

The Sleep-In™ Bone Screw Inserter is a disposable, battery operated, single use device. The Sleep-In™ Suture Passer is designed to assist in passing the suture through the floor of the tongue during the Sleep-In™ procedure.

Technological Characteristics and Substantial Equivalence:

The performance characteristics of the Sleep-In™ Bone Screw System has been tested and approved through a series of in vitro and in vivo studies.

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Furthermore, initial clinical experience with the Sleep-In™ Bone Screw System has demonstrated its potential for treating patients suffering from OSA and/or snoring.

The Sleep-In™ Bone Screw System, like its predicate devices the In-Fast™ Bone Screw System and the Mitek GII Anchor, is based on suspending soft tissue to fixed bone by means of sutures attached to bone screw.

In respect to the procedure, the Sleep-In™ System procedure is based upon well accepted and commonly used procedures like Hyoid Bone Suspension, Chin Osteotomy and Mandibular Advancement for the treatment of OSA and/or snoring.

The Sleep-In™ Bone Screw System is substantially equivalent to PM Positioner™ and the Snor-X Mouthguard with respect to the intended use for the treatment of OSA and/or snoring by means of repositioning of the tongue.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 2009

David Guzek Sr. Regulatory Specialist Medtronic ENT Medtronic USA, Inc. 6743 Southpoint Dr., N. Jacksonville, FL 32216-0980

Re: K972023 K981677

Dear Mr. Guzek:

We have reviewed your letters, received January 8, 2009, stating that the rights to the above referenced premarket notification (510(k)) have been transfer of 510(k) rights alone does not require submission of a new 510(k) under 21 CFR 807.81(a)(3). Consequently, we cannot change the name of the original 510(k) submitter in our database. Please note, as per 21 CFR 807.85(b), a firm may not both manufacture and distribute a device under their own name without having their own 510(k).

We suggest that information showing the transfer of the 510(k) and its current ownership should be maintained in the company's files for review by an FDA investigator. You may contact the Center for Devices and Radiological Health's Office of Compliance at (240) 276-0100 if you have any questions on what information we expect to be maintained in your files.

"Please note, under 21 CFR 807.81(a)(2) a firm may not both retain and transfer 510(k) marketing rights to another person, e.g., a contract manufacturer, because each person who manufactures and distributes a device must have their own 510(k), if the device is not exempt from the premarket notification requirement. Likewise, distributors need 510(k) clearances before marketing devices when they alter them by doing more than putting their name on the device, because such actions would disqualify them from the 510(k) distributor exemption under 21 CFR 807.85(b)."

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If you have any other questions regarding this letter, please contact the 510(k) Staff at (240) 276-4040.

Sincerely yours,

Juli Stuart

Julie "Brandi" Stuart Consumer Safety Officer Premarket Notification Section Program Operations Staff Office of Device Evaluation Center for Devices and Radiological Health

cc: Influence, Inc. 601 Montgomery Street, Suite 845 San Francisco, CA 94111

Influence, Inc. c/o Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington, DC 20004-1109

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INDICATIONS FOR USE

510(k) Number (if known):
Device Name:	Sleep-In™ Bone Screw System
Indications for Use:	The Sleep-In™ Bone Screw System isintended for anterior advancement of thetongue base by means of a bone screwthreaded with suture. It is indicated forthe treatment of obstructive sleep apnea(OSA) and/or snoring.

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

Concurrence of CI)RH, Office of Device Evaluation (ODE) (Division Sign-off) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Number K972063

Prescription Use V (Per 21 CFR 801. 109)

Susa Sumr

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number న్న

Over	the	Counter
Use

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.”