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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.

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.

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