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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.

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 bone 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 premounted on an inserter, a suspension line 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, 4) a size #2 braided polyester suspension line, and 5) a size #2 braided polyester suspension line with a radiopaque marker.

This document describes the 510(k) submission for the Siesta Medical, Inc. ENCORE™ Tongue Suspension System, emphasizing its substantial equivalence to a predicate device. The information provided focuses on non-clinical testing and explicitly states that no clinical testing was performed for this submission. Therefore, many of the requested details related to clinical studies, human reader performance, and ground truth establishment are not available in this text.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission pertains to a modification of an existing device and relies on showing substantial equivalence through non-clinical testing, specific "acceptance criteria" for clinical performance metrics (like sensitivity, specificity, or improvement in human reader performance) are not detailed. Instead, the focus is on performance specifications met through bench testing.

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

• Sample Size for Test Set: Not applicable in the context of clinical performance evaluation, as no human subject clinical testing was performed. The non-clinical tests would have used specific sample sizes for their materials/components, but these are not disclosed in this summary.
• Data Provenance: The non-clinical testing appears to be conducted by Siesta Medical, Inc. (manufacturer). No country of origin is specified for the data, but it's implied to be from the manufacturer's testing. All data is retrospective in the sense that it's from completed tests.

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

Not applicable. No ground truth based on expert consensus was established as no clinical study involving human assessment was conducted.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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 not an AI-assisted diagnostic tool, and no MRMC study was conducted. The device is a surgical implant.

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

Not applicable. This device is a surgical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the measurement of physical properties (e.g., tensile strength, fixation force, radiographic density) against predefined engineering specifications. This is distinct from clinical ground truth like pathology, expert consensus, or outcomes data, which are not relevant here.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of this device's evaluation, as it is not an AI/machine learning device.

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

Not applicable. There is no training set.

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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.

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.

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.

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.

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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.

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 bone 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, one of the following suspension sutures are provided depending on the model number: 1) a size #1 monofilament polypropylene suspension suture, 2) a size #1 monofilament polypropylene suspension suture with a radiopaque marker, 3) a size #2 monofilament polypropylene suspension suture with a radiopaque marker, or 4) a size #2 braided polyester suspension suture.

Similar to the PRELUDE III System, the ENCORE 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 ENCORE uses a Suture Passer and working suture loops to pass a suture from the posterior position in the tongue. The ENCORE advances the tongue in the anterior direction with a suspension suture. A Threading Tool is provided to ease passage of the suspension suture through the bone screw.

The provided text describes the 510(k) submission for the Siesta Medical, Inc. ENCORE Tongue Suspension System. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (PRELUDE III Tongue Suspension System) through performance testing, rather than a clinical study evaluating diagnostic or treatment effectiveness in humans.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes device performance testing (Suture Endurance Test and Bone Screw Fixation Strength Test), not a clinical study on human subjects or a diagnostic algorithm. Therefore, "test set" in the context of clinical data or AI evaluation is not directly applicable. The "samples" would refer to the physical devices or components tested. The exact number of samples for each engineering test is not specified in the provided text, nor is their "country of origin" as they are manufactured devices. These were likely prospective engineering tests performed in a lab setting.

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

This question is not applicable. The study described is not a clinical study involving human patients or an AI device requiring expert-established ground truth. The "ground truth" here is determined by the physical properties and performance benchmarks of the medical device components themselves.

4. Adjudication method for the test set

This question is not applicable as it refers to a clinical or AI study with human interpretation, not a bench test for device performance.

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

No, an MRMC comparative effectiveness study was not performed, nor is it applicable. This is a 510(k) submission for a physical medical device, not an AI or diagnostic tool that assists human readers.

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

No, this question is not applicable. The ENCORE Tongue Suspension System is a physical medical device, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for the device performance tests was based on engineering specifications and established performance benchmarks derived from the predicate device and potentially industry standards for medical device materials and components. For instance:

• Suture Endurance: The acceptance criterion was enduring 10.5 million cycles, which represents a physical performance threshold.
• Bone Screw to Suture Attachment Strengths: The ground truth was described as "written nominal ratings" and "favorable comparison to the predicate device," implying a quantitative or comparative engineering standard.

8. The sample size for the training set

This question is not applicable. As previously stated, this is a 510(k) submission for a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

This question is not applicable. There was no training set for an AI algorithm.

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