The Siesta Medical, Inc. PRELUDE III Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.

Device Description

The PRELUDE III Tongue Suspension System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw and suture. The PRELUDE III Tongue Suspension System consists of an integrated suture passer pre-loaded with size #2-0 braided polyester suture, a titanium bone screw that is pre-mounted on an inserter, a bone screw lock tool, and size 1 monofilament polypropelyne suspension suture.

Similar to the PRELUDE II System, the PRELUDE III Tongue Suspension System 1) uses a bone screw, 2) uses a bone screw inserter to place a bone screw into the bone, and 3) uses a needle to pass a suspension suture submucosally through the base of the tongue. The PRELUDE II uses a rigid curved needle to make an intramuscular suture pass from the oral cavity while the PRELUDE III uses a flexible needle to make an intramuscular suture pass without entering the oral cavity. The PRELUDE III uses a Suture Passer and suture loops to pass a polypropylene suture from the posterior to anterior position in the tongue. The PRELUDE III advances the tongue in the anterior direction with #1 polypropylene suture, which is passed through the base of the tongue and attached to the bone screw.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device (PRELUDE III™ Tongue Suspension System), which is a regulatory submission to demonstrate that a device is substantially equivalent to a predicate device. This type of submission focuses on comparing the new device's characteristics and performance to an already legally marketed device, rather than proving efficacy or creating a standalone AI algorithm. Therefore, many of the questions regarding AI-specific criteria (like training set size, ground truth for training, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, based on the provided text, we can describe the acceptance criteria and the study that proves the device meets the acceptance criteria within the context of a 510(k) submission for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically defined by demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as the predicate. This is often shown through comparisons of technological characteristics and performance testing. In this case, the performance criteria were related to the mechanical properties of the device components.

Acceptance Criteria (Performance)	Reported Device Performance (PRELUDE III™)
Suture Pass Reliability	Demonstrated, with at least 95% confidence and 90% reliability, that the suture is able to be passed from one Suture Passer to the other.
Suture Loop Pull-Out Force (vs. Predicate)	Showed no significant difference between the average pull-out force for the suspension suture loops made with the PRELUDE II (predicate) and PRELUDE III devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the numerical sample sizes for the "Suture Pass Reliability Test" or "Suture Loop Pull-Out Force" studies. It mentions statistical confidence and reliability for the suture pass test but not the number of units tested.
Data Provenance: The studies are in vitro (laboratory) studies conducted by Siesta Medical, Inc. The data provenance is internal to the manufacturer. The document doesn't specify country of origin for the data, but the company is based in Los Gatos, CA, USA. The studies are prospective in the sense that they were designed and executed to evaluate the new device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable. For a physical device demonstrating mechanical performance, "ground truth" is established by direct measurement and engineering specifications, not expert consensus as would be the case for an AI diagnostic algorithm.

4. Adjudication Method for the Test Set

This question is not applicable as there's no human interpretation or "adjudication" in the context of these in vitro mechanical tests. The results are quantitative measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

This question is not applicable. MRMC studies are specific to evaluating diagnostic accuracy and reader performance, typically for imaging devices or AI algorithms. This submission is for a surgical implantable device.

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

This question is not applicable. The PRELUDE III is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the in vitro studies, the "ground truth" was based on:

Engineering specifications and direct measurement: For Suture Pass Reliability, the "truth" was whether the suture successfully passed as designed.
Comparative mechanical strength: For Suture Loop Pull-Out Force, the "truth" was the measured force required for pull-out, compared directly against the predicate device's performance.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there is no "training set."

Summary

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APR - 8 2011 510(k) Summary (per 21CRF 807.92) Section 5

General Company Information
Name:	Siesta Medical, Inc.
Contact:	Michael Kolber
	Vice President, Regulatory Affairs
Address:	101 Church Street, Suite 3
	Los Gatos, CA 95030
Telephone:	408-505-6626
Fax:	408-399-7600
Date Prepared:	April 7, 2011
General Device Information
Product Name:	PRELUDE III™ Tongue Suspension System
Common Name:	Bone Screw System
Classification:	21CFR872.5570
	Intraoral devices for snoring and intraoral devices for snoring
	and obstructive sleep apnea.
Device Class:	Class II
Product Code:	ORY
Predicate Device
Manufacturer	Device Name	510(k) Number
Siesta Medical, Inc.	PRELUDE II TongueSuspension System	K103179

Description

Intended Use (Indications)

Substantial Equivalence

This submission supports the position that the Siesta Medical, Inc. PRELUDE III Tongue Suspension System is substantially equivalent to the PRELUDE II Tongue Suspension System (K103179). The 510(k) notice contains summaries of in vitro studies Suture Pass Reliability Test and Suture Loop

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KI10127

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510(k) for the Siesta Medical, Inc PRELUDE III Tongue Suspension System April 7, 2011

Pull Out Force used to evaluate the performance characteristics of the PRELUDE III Tongue Suspension System. The Suture Pass Reliability Test demonstrated, that with at least 95% confidence and 90% reliability, the suture is able to be passed from one Suture Passer to the other. The Suture Loop Pull-Out Force showed that there was no significant difference between the average pull out force for the suspension suture loops made with the PRELUDE II and PRELUDE III devices. The data demonstrate that the performance characteristics of the PRELUDE III Tongue Suspension System compare favorably to the predicate device. The single patient use components of the PRELUDE III Tongue Suspension System are provided sterile.

Conclusions

Siesta Medical, Inc. believes that the information provided demonstrates that the proposed device is substantially equivalent to the predicate device and does not raise any new issues of safety or efficacy. Based on the indications for use, technological characteristics, and comparison to the predicate device, the PRELUDE III Tongue Suspension System has been shown to be substantially equivalent to the predicate device as described under the Federal Food, Drug and Cosmetic Act.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Michael Kolber Vice President, Regulatory Affairs Siesta Medical, Incorporated 101 Church Street, Suite 3 Los Gatos, California 95030

APR - 8 2011

Re: K110127

Trade/Device Name: PRELUDE III™ Tongue Suspension System Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: ORY Dated: March 10, 2011 Received: March 11, 2011

Dear Mr. Kolber:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 l'ederal 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h for

Anthony Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number (if known): KIO127

Device Name: Siesta Medical, Inc. PRELUDE III™ Tongue Suspension System

Indications for Use: The Siesta Medical, Inc. PRELUDE III Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Ruaises

(Division Sign-OH)
Division of Anesthesiology, General Hospitad
Infection Control and Dental Devices
510(k) Number:
K162227

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.”