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The Encore System is intended for anterior advancement of the tongue base and hyoid suspension. It is indicated for the treatment of 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) three (3) bone screws and two (2) bone screw inserters, 3) a suspension line lock tool, 4) a threading tool, and 5) a drill bit. In addition, the following suspension lines are provided depending on the model number: 1) #2 braided polyester suspension line and 2) #2 braided polyethylene suspension line.

This document describes the Encore System, an intraoral device for treating obstructive sleep apnea (OSA) and snoring, and its substantial equivalence to a predicate device. The primary focus of this submission (K213159) is on updated MRI safety information and a minor drill bit length modification, rather than a clinical study evaluating the device's therapeutic effectiveness for OSA or snoring. Therefore, comprehensive acceptance criteria and a study proving therapeutic efficacy are not detailed in this 510(k) summary.

However, based on the provided text, we can infer the acceptance criteria for the MRI safety update and the corresponding testing:

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

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

The document describes non-clinical testing regarding MRI safety. Therefore, there is no "test set" of patient data in the context of clinical outcomes. The "sample size" would refer to the components tested in the MRI safety experiments. The document does not specify the exact number of components or systems tested.

• Data provenance: Non-clinical testing for MRI compatibility. The country of origin for this testing is not specified, but it would typically be conducted by a certified testing lab.

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

N/A. As this is non-clinical MRI safety testing, there are no human experts establishing "ground truth" in the clinical sense. MRI safety evaluations typically rely on established testing standards and protocols interpreted by engineers and physicists specializing in MR compatibility.

4. Adjudication method for the test set

N/A. There is no clinical test set requiring adjudication in this context. The MRI safety testing follows standardized protocols, and results are typically evaluated against pre-defined thresholds.

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

N/A. This 510(k) submission is for an intraoral device, not an AI or imaging diagnostic device. Therefore, an MRMC study is not applicable.

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

N/A. This 510(k) submission is for an intraoral device, not an algorithm.

7. The type of ground truth used

For the MRI safety testing, the "ground truth" is defined by established international standards (e.g., ASTM F2052, ASTM F2182) and the physical properties of the materials and device. The acceptance criteria are derived from these standards and generally accepted safety limits for MRI.

8. The sample size for the training set

N/A. This is a non-clinical MRI safety evaluation, not a machine learning or AI algorithm development.

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

N/A. See point 8.

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The Encore System is intended for anterior advancement of the tongue base and hyoid suspension. It is indicated for the treatment of 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) three (3) bone screws and two (2) bone screw inserters, 3) a suspension line lock tool, 4) a threading tool, and 5) a drill bit. In addition, a #2 braided polyethelene suspension line is provided. All components are provided sterile.

This document is a 510(k) Pre-Market Notification from the FDA regarding the Siesta Medical Encore System. It's a regulatory clearance document and does not contain the detailed study results, acceptance criteria, or performance metrics typically found in a clinical study report.

Therefore, I cannot provide the requested information, which includes a table of acceptance criteria and reported device performance, sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, details of MRMC studies (effect size), standalone performance, or ground truth establishment.

The document states:

• The device is the Encore™ System.
• Intended Use: Anterior advancement of the tongue base and hyoid suspension for the treatment of obstructive sleep apnea (OSA) and/or snoring.
• Change: The current submission (K201238) introduces a #2 braided polyethylene suspension line (vs. #2 braided polyester in the predicate K183310).
• Non-Clinical Testing: A "Suture Tensile Strength Test" was conducted.
• Conclusion of Testing: The results "confirmed that the strength of the #2 braided polyethylene suspension is similar to that of the existing #2 braided polyester suspension line."

This type of submission typically relies on demonstrating substantial equivalence to a predicate device, focusing on a specific change (in this case, the material of the suspension line) and ensuring that the new material does not negatively impact the device's fundamental function or safety. The "Suture Tensile Strength Test" is the evidence provided to support this claim, indicating that the new suspension line has comparable strength to the old one.

Without further documentation, it is impossible to fulfill the request for detailed study information.

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The Encore System is intended for anterior advancement of the tongue base and hyoid suspension. It is indicated for the treatment of 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) bone screws and two (2) 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 breakdown of the acceptance criteria and study information for the Encore System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The clinical performance was assessed through a literature review of 377 total patients across 16 studies. For the Encore System specifically, 45 patients from 2 studies were included.
• Data Provenance: The data is from a literature review of peer-reviewed clinical studies. The document does not specify the country of origin but implies various clinical settings where these studies were conducted. The data is retrospective, drawn from existing published research.

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

This section is not applicable as the provided text describes a literature review of existing clinical data rather than a study involving a prospectively collected test set with ground truthing by experts. The "ground truth" here is the reported clinical outcomes in the published studies.

4. Adjudication Method for the Test Set

This information is not applicable as the data is from a literature review of already published clinical studies, not a new test set requiring expert adjudication.

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 device described is a medical implant (the Encore System) for treating sleep apnea, not an AI-assisted diagnostic or treatment planning tool that would involve human readers or AI assistance in the way typically seen in image analysis or diagnostic AI.

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

This information is not applicable. The device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the clinical performance assessment was derived from outcomes data reported in peer-reviewed clinical studies, specifically the Apnea Hypopnea Index (AHI) reduction and complication rates. For the bench testing, the ground truth was established by passing specified engineering and materials tests (e.g., "Pass" criteria for endurance and fixation strength).

8. The Sample Size for the Training Set

This information is not applicable. The context is the evaluation of a medical device (implant) and not the training of a machine learning model.

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

This information is not applicable for the same reason as above (not an AI/ML context).

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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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