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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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