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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.

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.

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.

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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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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.

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.

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.

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."

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The Siesta Medical, Inc. PRELUDE II 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 PRELUDE II 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 II Tongue Suspension System consists of a pair of suture passers 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.

The provided document is a 510(k) summary for the Siesta Medical, Inc. PRELUDE II Tongue Suspension System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or specific study results that would prove the device meets such criteria in terms of clinical performance or effectiveness.

The "studies" mentioned are in vitro tests conducted to evaluate the performance characteristics of the PRELUDE II Tongue Suspension System compared to a predicate device, focusing on mechanical properties rather than clinical outcomes. These are:

• Suture Endurance Test
• Bone Screw Torque Strength Test
• Bone Screw Fixation Strength Test

Therefore, I cannot provide a table of acceptance criteria for clinical performance or details of a study proving the device meets those criteria, as this information is not present in the provided text.

Based on the provided text, I can only state the information that is present:

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

The document mentions three in vitro tests and states: "The data presented demonstrate that the performance characteristics of the PRELUDE II Tongue Suspension System compare favorably to the predicate device." No specific quantitative acceptance criteria or detailed performance data from these tests are provided in this summary.

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

• Sample Size: Not specified for the in vitro tests.
• Data Provenance: The in vitro studies were conducted as part of the 510(k) submission process, likely by the manufacturer (Siesta Medical, Inc.). No country of origin is specified. The studies are described as in vitro, meaning they were laboratory tests, not human or animal studies, and thus are not retrospective or prospective in a clinical sense.

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

This is not applicable as the studies described are in vitro mechanical tests, not clinical studies requiring expert ground truth for diagnosis or outcome assessment.

4. Adjudication method for the test set:

Not applicable, as the described studies are in vitro mechanical tests.

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 medical implant (a tongue suspension system), not an AI-powered diagnostic or assistive technology.

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

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

7. The type of ground truth used:

For the in vitro tests, "ground truth" would refer to established engineering and material science standards for evaluating suture endurance, screw torque strength, and fixation strength. The document only states that the performance "compare favorably to the predicate device," implying a comparison against an already approved device's characteristics, which serves as a benchmark rather than a "ground truth" in the clinical sense.

8. The sample size for the training set:

Not applicable. This document describes in vitro mechanical tests, not machine learning or AI algorithm development which would have training sets.

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

Not applicable, for the same reasons as above.

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The Siesta Medical, Inc. PRELUDE 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 PRELUDE 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 Tongue Suspension System consists of a pair of suture passers pre-loaded with size 2.0 braided polyester suture, a titanium bone screw that is pre-mounted on an inserter and size 1 monofilament polypropelyne suspension suture.

The Siesta Medical, Inc. PRELUDE Tongue Suspension System is a medical device designed for anterior tongue base suspension to treat mild or moderate obstructive sleep apnea (OSA) and/or snoring. The 510(k) submission (K101060) describes the device and the studies conducted to demonstrate its substantial equivalence to predicate devices, focusing on its performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the performance tests conducted but does not explicitly define "acceptance criteria" as quantifiable thresholds. Instead, it states that the performance compares favorably to predicate devices. The reported device performance is qualitative, indicating successful completion of the tests.

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

The provided 510(k) summary does not specify the sample sizes used for each of the in vitro mechanical tests. It only states that the tests were "conducted to evaluate the performance characteristics." The data provenance for these in vitro tests would typically be from laboratory testing performed by or for the manufacturer, Siesta Medical, Inc. The document does not specify country of origin for the data, but since the company is based in Los Gatos, CA, it's likely the testing was conducted in the USA or by labs commissioned by them. The study is an in-vitro performance evaluation, not a clinical study, so the terms "retrospective" or "prospective" do not directly apply in the same way they would to human subject research.

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

This information is not applicable as the studies described are in vitro mechanical performance tests. They do not involve human interpretation or subjective assessment that would require expert ground truth establishment in the way an AI diagnostic or image analysis system would. The "ground truth" for these tests is based on objective physical measurements and engineering principles.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in clinical studies or expert review processes, typically for establishing consensus ground truth for subjective data (e.g., image interpretation). The mechanical tests performed for this device rely on objective measurements.

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:

This information is not applicable. The PRELUDE Tongue Suspension System is a physical medical device (an implantable system), not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is entirely irrelevant to this device.

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

This information is not applicable. The device is an implantable physical system, not an algorithm or AI system.

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

For the in vitro mechanical tests, the "ground truth" is established through objective physical measurements using calibrated testing equipment and adherence to standard engineering test methodologies (e.g., tensile strength, torque, fixation strength). It is based on the inherent physical properties and performance limits of the materials and design, not on expert consensus, pathology, or clinical outcomes data in the traditional sense.

8. The sample size for the training set:

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles, material science, and preclinical testing, rather than data-driven machine learning models.

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

This information is not applicable for the same reasons as point 8.

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