(562 days)
The Anti-Snoring Device is intended for use in stiffening the soft palate tissue which may reduce the severity of snoring in some individuals.
The Pi Medical Anti-Snoring Device is intended as a treatment option for snoring and consists of an implant and a delivery tool. The Anti-Snoring Device is designed to stiffen the tissue of the soft palate and to reduce the dynamic flutter of those tissues without interfering with the normal function of the soft palate.
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 permanent while the delivery tool is disposable.
The implant is available in a range of lengths, 0.59" to 1.38" and three different diameters: 0.050", 0.064", and 0.087". Corresponding delivery tool sizes are: 16Ga, 14Ga and 12Ga. The different sizes allow the physician to tailor the size of the implant to the patient's anatomy.
This 510(k) summary describes a medical device, the Pi Medical Anti-Snoring Device, which is intended to stiffen the soft palate tissue to reduce snoring. However, the provided document DOES NOT contain the detailed information necessary to answer the questions about acceptance criteria and the specifics of a study proving the device meets those criteria.
The document is a 510(k) summary for regulatory submission, which primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's design, intended use, and general testing categories. It is not an efficacy study report.
Here’s what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Integrity | Met or exceeded requirements |
| Mechanical Performance | Met or exceeded requirements |
| Reliability | Met or exceeded requirements |
| Biocompatibility | Met or exceeded requirements |
| Insertion Ability | Met or exceeded requirements |
| Preclinical Performance | Met or exceeded requirements |
Explanation: The document states, "The Anti-Snoring Device met or exceeded all performance requirements." However, it does not specify what those "requirements" or "acceptance criteria" were (e.g., specific thresholds for dimensional tolerance, force resistance, or biological response).
Missing Information/Not Applicable (based on the provided text):
2. Sample size used for the test set and the data provenance:
- Not provided. The document mentions "preclinical performance" but no details about clinical trial sample sizes, human subject data, or its origin (country, retrospective/prospective). This submission is from 2002, and the focus is on "substantial equivalence" based on physical and performance characteristics, not necessarily clinical efficacy data like modern device submissions might require for certain claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a "test set" requiring expert ground truthing in the context of clinical efficacy or diagnostic performance. The testing described is primarily engineering/material performance.
4. Adjudication method for the test set:
- Not applicable. No mention of a test set requiring adjudication in the clinical sense.
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 an implantable anti-snoring device, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical implant, not a software algorithm.
7. The type of ground truth used:
- Not explicitly stated in the context of clinical efficacy. For the engineering/material performance tests, the "ground truth" would be established by the specifications and standards applied to each test category (e.g., dimensional specifications, mechanical strength standards, biocompatibility protocols). There is no mention of pathology, outcomes data, or expert consensus related to the device's clinical performance. The "preclinical performance" likely refers to bench testing or animal studies, but details are not provided.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that would have a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set.
In summary: The provided 510(k) summary for the Pi Medical Anti-Snoring Device demonstrates that the device underwent various engineering and material performance tests (dimensional, mechanical, reliability, biocompatibility, insertion ability, preclinical) and "met or exceeded all performance requirements." However, the document does not elaborate on the specific acceptance criteria, method, or results for these tests, nor does it present data from a clinical study on human subjects with ground truth for snoring severity, which would be necessary to answer most of your detailed questions. The 510(k) pathway relies on demonstrating substantial equivalence to previously cleared devices rather than requiring extensive de novo clinical efficacy studies in all cases.
§ 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.”