(53 days)
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.
| Test Type | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Summary) |
|---|---|---|
| Suture Endurance Test | (Not specified in document) | Performance characteristics compare favorably to predicate. |
| Bone Screw Torque Strength Test | (Not specified in document) | Performance characteristics compare favorably to predicate. |
| Bone Screw Fixation Strength Test | (Not specified in document) | Performance characteristics compare favorably to predicate. |
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.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”