(84 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Suture tensile strength meets or exceeds predicate devices. | Post-Sterilization Suture Tensile Strength Test: Data presented demonstrates favorable comparison to predicate devices. |
| Suture endurance meets or exceeds predicate devices. | Suture Endurance Test: Data presented demonstrates favorable comparison to predicate devices. |
| Bone screw insertion torque is appropriate for clinical use and comparable to predicate devices. | Bone Screw Insertion Torque Test: Data presented demonstrates favorable comparison to predicate devices. |
| Bone screw torque strength is sufficient for intended use and comparable to predicate devices. | Bone Screw Torque Strength Test: Data presented demonstrates favorable comparison to predicate devices. |
| Bone screw fixation strength is sufficient for intended use and comparable to predicate devices. | Bone Screw Fixation Strength Test: Data presented demonstrates favorable comparison to predicate devices. |
| Device components are supplied sterile. | The single patient use components of the PRELUDE Tongue Suspension System are provided sterile. |
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.
§ 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.”