The Siesta Medical, Inc. ENCORE 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 ENCORE Tongue Suspension System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible using a bone screw and suture. The ENCORE 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 a Threading Tool. In addition, the following suspension lines are provided depending on the model number: 1) a size #1 monofilament polypropylene suspension line, 2) a size #1 monofilament polypropylene suspension line with a radiopaque marker, 3) a size #2 monofilament polypropylene suspension line with a radiopaque marker, and 4) a size #2 braided polyester suspension line.

Similar to the predicate ENCORE System, the modified ENCORE Tongue Suspension System 1) uses a bone screw, 2) a bone screw inserter to place a bone screw into the bone, and 3) a needle to pass a suspension suture submucosally through the base of the tongue. The ENCORE uses a Suture Passer and working suture loops to pass a suture from the posterior to anterior position in the tongue. The ENCORE advances the tongue in the anterior direction with a suspension line. A Threading Tool is provided to ease passage of the suspension line through the bone screw.

AI/ML Overview

The provided text describes a medical device submission (K121814) for the Siesta Medical, Inc. ENCORE Tongue Suspension System. This submission is for a modification to an existing device (predicate device K111179).

The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically include detailed studies proving specific performance criteria and clinical efficacy in the same way a PMA (Premarket Approval) would. Instead, it focuses on demonstrating equivalence to a device that has already been cleared.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this 510(k) summary. The summary explicitly states: "This submission supports the position that the Siesta Medical, Inc. modified ENCORE Tongue Suspension System is substantially equivalent to the predicate ENCORE Tongue Suspension System (K111179). The 510(k) includes a test report to support extension of the shelf-life to 2 years."

Here's what can be inferred or explicitly stated from the provided text, while also noting what is absent:

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

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for the modified device. The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device in terms of intended use, operating principle, technology, and manufacturing process.
Reported Device Performance: The document only mentions a "test report to support extension of the shelf-life to 2 years." This is a specific performance claim related to durability/stability, but no other performance metrics (e.g., success rate of tongue advancement, reduction in AHI, or adverse event rates) are provided for the modified device in this summary.

Acceptance Criteria (Implied for 510(k)	Reported Device Performance
Substantial Equivalence to Predicate	Stated to be substantially equivalent in intended use, operating principle, technology, and manufacturing process.
Shelf-life	Extended to 2 years (supported by a test report).

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 only refers to "a test report to support extension of the shelf-life." This likely refers to bench testing, not a clinical test set on patients.
Data Provenance: Not specified. Given it's a shelf-life test, it would typically be laboratory-based rather than patient-based.

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/Not specified. This information is typically relevant for studies involving subjective human assessment (e.g., image interpretation), which is not the type of data presented in this 510(k) summary.

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

Not applicable/Not specified. Adjudication methods are typically for clinical trials or diagnostic accuracy studies where multiple observers or subjective assessments are involved.

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

Not applicable. This device is a surgical implant for tongue suspension, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical medical device, not an algorithm or AI system.

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

For the shelf-life extension, the "ground truth" would likely be objective measurements of material degradation or functional performance over time, according to established engineering and material science standards. No clinical ground truth is discussed for the modified device itself.

8. The sample size for the training set

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

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

Not applicable. This is not a machine learning or AI device.

Summary of what the K121814 submission does provide:

It states the device's intended use: "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."
It claims substantial equivalence to the predicate device (K111179) in terms of intended use, operating principle, technology, and manufacturing process.
It specifically mentions "a test report to support extension of the shelf-life to 2 years" as a new piece of supporting data for the modification.
It provides a detailed description of the device components and how they function, highlighting similarities to the predicate.

This 510(k) notification is primarily a regulatory filing to demonstrate that a modified device is as safe and effective as a previously cleared device, rather than a clinical study establishing new performance metrics for an entirely novel device. Therefore, the detailed study information sought is typically not part of these submissions.

Summary

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K121814

NOV 7 2012

Image /page/0/Picture/2 description: The image shows the logo for Siesta Medical. The word "Siesta" is in large, bold, black letters with a curved line above it. Below "Siesta" is the word "Medical" in smaller, bold, black letters. The logo is simple and professional.

510(k) for the Siesta Medical, Inc. ENCORE Tongue Suspension System August 3, 2012

Appendix 3: 510(k) Summary

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:	July 31, 2012
General Device Information
Product Name:	ENCORE™ 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.	ENCORE Tongue	K111179
	Suspension System

Description

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510(k) for the Siesta Medical, Inc. ENCORE Tongue Suspension System August 3, 2012

Intended Use (Indications)

Substantial Equivalence

The ENCORE Tongue Suspension System has the following similarities to the previously cleared predicate device: the same intended use, operating principle, technology, and manufacturing process. This submission supports the position that the Siesta Medical, Inc. modified ENCORE Tongue Suspension System is substantially equivalent to the predicate ENCORE Tongue Suspension System (K111179). The 510(k) includes a test report to support extension of the shelf-life to 2 years.

Conclusions

Siesta Medical, Inc. believes that the information provided demonstrates that the modified 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 modified ENCORE Tongue Suspension System has been shown to be substantially equivalent to predicate device as described under the Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 7, 2012

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

Re: K121814

Trade/Device Name: ENCORETM 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: October 8, 2012

Received: October 9, 2012

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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Page 2 - Mr. Kolber

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); 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for Kwame O. Ulme

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory. Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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510(k) for the Siesta Medical, Inc. ENCORE Tongue Suspension System June 19, 2012

Indications for Use

510(k) Number (if known): K1218/Y

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

Indications for Use: The Siesta Medical, Inc. ENCORE 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.

Susan Reenn

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

X | 2 | 8 | 4 510(k) Number:

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)

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.”