(344 days)
The Pillar Palatal Implant System is intended for use in stiffening the soft palate tissue which may reduce the severity of snoring in some individuals.
Indications for use of the System include: symptomatic, habitual, and social snoring due to palatal flutter.
The Pillar Palatal Implant System is intended as a treatment option for snoring. The Pillar Palatal Implant System consists of an implant and a delivery tool. The implants are designed to stiffen the tissue of the soft palate reducing the dynamic flutter which causes snoring.
The implant is a cylindrical shaped segment of braided polyester filaments. The delivery tool is comprised of a handle and needle assembly that allows for positioning and placement of the implant submucosally in the soft palate. The implant is designed to be permanent while the delivery tool is disposable.
The provided text is a 510(k) summary for the Medtronic Xomed, Inc. Pillar Palatal Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial with quantitative performance metrics.
Therefore, many of the requested items (acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable or available within this type of regulatory submission.
The essence of this submission is substantial equivalence, meaning the device is considered as safe and effective as a legally marketed predicate device, rather than a de novo demonstration of meeting novel performance criteria through a specific study.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not applicable in the context of this 510(k) submission. The submission does not present specific quantitative acceptance criteria or performance metrics for this device, as it relies on substantial equivalence to a previously cleared device. The "performance" being demonstrated is the identity in intended use, indications for use, design, implant, and target population to the predicate device.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Asserted Substantial Equivalence) |
|---|---|
| Intended Use: Functionally identical to predicate device. | "The Pillar Palatal Implant System is identical in intended use..." |
| Indications for Use: Same indications as predicate device. | "...indications for use..." |
| Design: Similar construction and materials to predicate device. | "...design..." |
| Implant: Same type of implant as predicate device. | "...intended implant..." |
| Target Population: Treats the same patient group as predicate device. | "...and target population to the previously cleared Pillar Palatal Implant System." |
| Effective and performs as well as the predicate device. | "The Pillar Palatal Implant System is as effective, and performs as well as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This submission is not based on a clinical trial with a "test set" in the context of a new performance study. It's a regulatory filing based on demonstrating equivalence. No specific patient sample size or data provenance for a performance test is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. See point 2.
4. Adjudication Method for the Test Set:
Not applicable. See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical implant system, not an AI-assisted diagnostic or treatment system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical implant system.
7. The type of ground truth used:
Not applicable. There is no "ground truth" in the context of a new performance study for this submission. The "truth" being established is the substantial equivalence to a previously cleared device based on a comparison of device characteristics and intended use.
8. The Sample Size for the Training Set:
Not applicable. This submission does not involve machine learning or AI, and therefore no "training set" in that sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. See 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.”