The ENCORE System is intended to be used for anterior advancement of the tongue base. It is also suitable for performing hyoid suspension. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.

Device Description

The ENCORE System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone and hyoid bone suspension to the mandible bone using a bone screw and suspension lines. The ENCORE System consists of 1) an integrated suture passer pre-loaded with size #2-0 braided polyester suture, 2) two (2) bone screws and bone screw inserters, 3) a suspension line lock tool, and 4) a threading tool. In addition, the following suspension lines are provided depending on the model number: 1) a #2 monofilament polypropylene suspension line with a radiopaque marker, 2) a size #2 braided polyester suspension line, and 3) a size #2 braided polyester suspension line with a radiopaque marker.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Siesta Medical, Inc. ENCORE System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state quantitative "acceptance criteria" in the format one might expect for a clinical trial's primary endpoints (e.g., AHI reduction by a certain percentage with a specific p-value threshold). Instead, it relies on demonstrating substantial equivalence to predicate devices and shows that the device performs at least as well as and is as safe and effective as the predicates.

For the non-clinical testing, the criteria were implicitly that the device met performance specifications for:

Suspension Line Endurance: Demonstrated to meet specifications (specific values not provided in this summary).
Bone Screw-to-Suspension Line Fixation Strength: Demonstrated to meet specifications (specific values not provided in this summary).

For the clinical performance, the reported outcomes are compared against the understanding of predicate device performance and general clinical efficacy for hyoid suspension.

Acceptance Criteria (Implicit from Submission)	Reported Device Performance
Non-Clinical:
Meet performance specifications for Suspension Line Endurance.	Demonstrated to meet performance specifications.
Meet performance specifications for Bone Screw-to-Suspension Line Fixation Strength.	Demonstrated to meet performance specifications.
Clinical:
Be as safe and effective as predicate devices for anterior advancement of the tongue base and hyoid suspension.	Literature Review: 11 clinical studies (461 patients) involving hyoid suspension reported few complications, with six studies reporting no significant intraoperative or post-operative complications. Patient Series: 1 patient series (number of patients not explicitly stated for this series alone, but included from context of a retrospective analysis) showed similar efficacy and safety.
	Reduction in AHI/RDI from 52.8 to 11.8 (78%, p<0.01) in the patient series, with mean follow-up of 75 days.
No new safety or performance issues compared to predicate devices.	No new safety or performance issues raised during testing.
Substantial equivalence to predicate devices (indications for use and technological characteristics).	Determined to be substantially equivalent based on non-clinical and clinical data.

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

Non-Clinical (Bench Testing): The document does not specify the exact sample sizes (e.g., number of devices or components) used for the Suspension Line Endurance Test and Bone Screw-to-Suspension Line Fixation Strength Test.
Clinical (Patient Series): "A series of patients treated for OSA using hyoid suspension with the Encore System." The exact number of patients in this specific patient series is not explicitly stated in the summary, but it implies a single cohort. It mentions a mean age of 58.3 years, mean BMI of 27.9 kg/m², and baseline AHI/RDI of 45.0. It's a retrospective analysis. The country of origin is not specified but implicitly assumed to be the US, given the FDA submission.
Clinical (Literature Review): 11 clinical studies involving 461 patients. This is a review of retrospective and/or prospective studies previously published in peer-review literature. The countries of origin for these studies are not specified.

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

This type of information is generally not applicable to a 510(k) submission for a device like the ENCORE System. The "ground truth" for non-clinical testing is based on engineering specifications and direct measurement. For clinical studies, the "ground truth" (e.g., diagnosis of OSA, AHI/RDI measurement, complication reporting) is established by the clinical investigators and standard medical diagnostic procedures, not typically by a panel of independent experts for the purpose of a 510(k) submission comparison in this context. The peer-reviewed literature would have been subject to its own expert review processes, but this is distinct from experts establishing 'ground truth' for the 510(k) submission itself.

4. Adjudication Method for the Test Set

Not applicable. This device's evaluation does not involve subjective "reads" that would require adjudication. Clinical outcomes (e.g., AHI reduction, complications) are typically objectively measured or reported by treating physicians.

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. The ENCORE System is a physical medical device (bone screw system for tongue/hyoid suspension), not an AI algorithm or imaging device requiring human reader interpretation. No MRMC study was conducted or relevant.

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

Not applicable. The ENCORE System is a physical medical device. No algorithm is involved in its direct function for standalone performance evaluation in this context.

7. The Type of Ground Truth Used

Non-Clinical: Engineering specifications and direct physical measurements for endurance and fixation strength.
Clinical (Patient Series & Literature Review):
- Diagnosis of OSA: Likely based on polysomnography (PSG) and clinical evaluation according to established medical guidelines.
- Severity of OSA: Measured by AHI (Apnea-Hypopnea Index) and/or RDI (Respiratory Disturbance Index) from PSG.
- Clinical Outcomes: Reduction in AHI/RDI, resolution of snoring, reported complications (e.g., wound seroma).
- Medical opinion/diagnosis by the treating physicians and authors of the peer-reviewed studies.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set in the machine learning sense. The "training" in a broad sense would be the cumulative clinical experience with similar devices and procedures and the engineering design and testing cycles, not a data-driven training set.

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

Not applicable, as there is no "training set" for a physical device in this context.

Summary

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510(k) for the Siesta Medical, Inc. ENCORE System March 26, 2014

510(k) Summary

510(k) Number	K133680
Submitter Name and Address
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	March 26, 2014
General Device Information
Product Name	ENCORE™ System
Common Name	Bone Screw System
Classification	21CFR872.5570Intraoral devices for snoring and intraoraldevices for snoring and obstructive sleepapnea.
Device Class	Class II
Product Code	ORY
Predicate Device
Manufacturer	Device Name	510(k) Number
Siesta Medical, Inc.	ENCORE TongueSuspension System	K121440
Medtronic, Inc.	AIRvance System	K122391
Device Description
The ENCORE System is designed for anterior tongue base suspension by fixationof the soft tissue of the tongue base to the mandible bone and hyoid bonesuspension to the mandible bone using a bone screw and suspension lines. TheENCORE System consists of 1) an integrated suture passer pre-loaded with size#2-0 braided polyester suture, 2) two (2) bone screws and bone screw inserters, 3)a suspension line lock tool, and 4) a threading tool. In addition, the followingsuspension lines are provided depending on the model number: 1) a #2monofilament polypropylene suspension line with a radiopaque marker, 2) a size#2 braided polyester suspension line, and 3) a size #2 braided polyestersuspension line with a radiopaque marker.
Intended Use (Indications)
The ENCORE System is intended to be used for anterior advancement of the

tongue base. It is also suitable for performing hyoid suspension. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or

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snoring.

Comparison to the Predicate Device

The ENCORE System has a modified intended use compared to the predicate devices. The intended use has been modified to include a statement that it is also suitable for the performance of a hyoid suspension procedure.

With regard to the modified intended use, similar to the predicate device, a needle is used to pass a suspension suture around the hyoid bone and a bone screw is used to anchor the suture with the desired amount of tension. The difference between the predicate device and the ENCORE System relates to how the suspension sutures are fixed once the desired level of advancement is achieved. In the predicate device, the suspension sutures are provided pre-attached to the bone anchors, which requires the tails of the suspension sutures to be joined or fixed at the midline of the hyoid bone with a knot once they are passed around the hyoid bone. With the ENCORE System the suspension sutures are passed around the hyoid bone and then attached to the bone anchors without the need to tie a knot.

The fundamental scientific technology and technological characteristics of the ENCORE System are the same as the predicate devices including mechanism of action, packaging, biocompatibility, sterilization, and labeling. The ENCORE System contains the same materials and components as the predicate ENCORE System. Through bench performance and clinical testing it was demonstrated that the modified intended use do not adversely affect safety and effectiveness.

Summary of Non-Clinical and Clinical Testing

The non-clinical test data provided in this submission demonstrated that the ENCORE System meets the performance specifications. The submission includes a Suspension Line Endurance Test and Bone Screw-to-Suspension Line Fixation Strength Test.

The non-clinical testing was performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.

The clinical data provided in this submission includes a summary of eleven (11) clinical studies in 461 patients involving hyoid suspension published in the peerreview literature. There were few complications reports, with six studies reporting no significant intraoperative or post-operative complications.

This submission also includes an analysis of a series of patients treated for OSA

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using hyoid suspension with the Encore System. This patient series included primarily males, with a mean age of 58.3 years, mean BM1 of 27.9 kg/m², and a baseline AHI/RDI of 45.0. Hyoid suspension was successful in all patients. One patient had a post-operative wound seroma that resolved. Mean follow-up time was 75 days, with a reduction in AHI/RDI from 52.8 to 11.8 (78%, p<0.01).

The literature review and patient series shows that this treatment is often used successfully to reduce hypopharyngeal airway compromise, and may be used in combination with other surgical procedures (i.e., tongue suspension) that address additional sites of obstruction in the airway.

The use of hyoid suspension is an effective method to treat hypopharyngeal-based obstructions and can be used in combination with other procedures to effectively treat obstructive sleep apnea with or without tongue suspension.

Conclusion: The Encore System is physically identical to the predicate device, justifying no new nonclinical testing. Based on a review of the peer-review literature and a retrospective analysis of patients treated using hyoid suspension, we conclude that the Encore System is as safe and effective and performs as well or better than the predicate device.

Statement of Equivalence

The ENCORE System has similar indications for use and the same technological characteristics as the predicate devices. Based on this and the data provided in this pre-market notification, the subject device and the predicate device have been shown to be substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

March 26, 2014

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

Re: K133680

Trade/Device Name: ENCORE™ 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: December 31, 2013 Received: January 2, 2014

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Mary S. Runner -S

Erin 1. Keith, M.S. Acting Division 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 System November 30, 2013

Indications for Use

510(k) Number (if known): _____________

Device Name: Siesta Medical, Inc. ENCORE™ System

Prescription 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)

Andrew 5:17 -04'00' 2014.03.26 08:5

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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.”