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510(k) Data Aggregation
(224 days)
The Elevo® Kit Snoring Intervention Device 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 Elevo® Kit Snoring Intervention Device include symptomatic, habitual, and social snoring due to palatal flutter.
The Elevo® Kit Snoring Intervention Device is comprised of three (3) sterile, absorbable, and barbed, polydioxanone (PDO) sutures and three (3) corresponding disposable, sterile, single use suturing needles. A disposable tension suture (DTS) is attached to the proximal end of each of the barbed PDO suture implants. The proximal end of the DTS is secured to the suturing needle handle during device assembly.
This document describes the premarket notification (510(k)) for the Elevo® Kit Snoring Intervention Device, which aims to stiffen the soft palate tissue to reduce snoring. The acceptance criteria and the study proving the device meets these criteria are detailed below, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The device's acceptance criteria are primarily demonstrated through equivalence testing against a predicate device (Pillar™ Palatal Implant System) and a reference device (Quill™ Absorbable Suture), and through clinical safety and efficacy studies with statistically significant results. The "acceptance criteria" here are interpreted as the demonstrated performance that deems the device substantially equivalent to the predicate.
| Acceptance Criteria (Demonstrated Equivalence/Performance) | Reported Device Performance (Elevo® Kit Snoring Intervention Device) |
|---|---|
| Indications for Use Equivalence | Identical: "The Elevo® Kit Snoring Intervention Device is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals." |
| Material Equivalence (Implant) | Absorbable Polydioxanone (PDO). Identified as identical to the Reference Device (Quill™ Synthetic Absorbable Barbed Suture). |
| Sterilization Method Equivalence | Ethylene Oxide (EtO). Identical to predicate and reference devices. |
| Labeling: Sterile, Single Use Equivalence | Yes. Identical to predicate and reference devices. |
| Outpatient - Office Based Procedure Equivalence | Yes. Identical to predicate device. |
| Biocompatibility | Yes. Stated as biocompatible. Identical to predicate and reference devices. |
| Mechanism of Action/Delivery Method Equivalence | Disposable, sterile, single use, handheld suturing needle and proprietary suture implant technique (similar to predicate's handheld pellet delivery needle). |
| Tensile Strength (Implant) | Comparable to reference device (Quill™ PDO Synthetic Absorbable Barbed Suture), demonstrated by in vitro pull-force testing in bovine material. Specific quantitative results are mentioned as being in Section 12, Table 12-5, but not provided in this excerpt. |
| Device Description (General) | Designed to stiffen the tissue of the soft palate and reduce dynamic flutter without interfering with normal function. Identical concept to predicate device. |
| Anatomic Target Location | Nearly identical to predicate device: 5-6 mm distal (posterior) to the soft palate/hard palate junction. |
| Clinical Safety | Equivalent to or exceeds predicate device (Pillar™ Palatal Implant System). |
| Adverse Events | Zero unanticipated adverse events reported. Four anticipated events (dysphagia, sore throat, palpable suture, oral hematoma) observed and prospectively defined as Common Treatment Events. |
| Clinical Efficacy (Snoring Severity Reduction) | Snoring severity (0-10 VAS by bed partner) reduced by average 25% or more at Day 30, Day 90, and Day 180 post-procedure. (Day 30: 25.9% reduction from 7.81 to 5.79; Day 90: 30.6% reduction from 7.81 to 5.42; Day 180: 30.8% reduction from 7.81 to 5.40). p < 0.001 for all time points. Comparable efficacy to predicate device's best comparative study. |
| Study Completion Rate | 87% of patients completed all endpoints (N=45 of 52). Higher than predicate's comparable study (80%). |
| Lost-to-follow-up Rate | 13%. Lower than predicate's comparable study (20%). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study (Test Set): 52 study subjects were enrolled in the trial.
- 18 female, 34 male.
- Age range: 22 to 78 years (mean 44 years).
- Data Provenance: The study was designated a Non-Significant Risk clinical trial and was conducted between March and September 2017. The document does not explicitly state the country of origin, but the FDA submission implies a US-based or FDA-compliant study. It was a prospective, multi-center study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The primary efficacy endpoint, snoring severity, was established by the bed/sleep partners of the study subjects. They were trained on the use of an external outcomes-tracking database (eORO) and entered their objective scoring of each Study Subject's snoring severity. Clinical Coordinators at each investigational site did not obtain these results to minimize bias.
For the assessment of a patient's AHI score (Apnea Hypopnea Index), which was part of the inclusion criteria (AHI < 15), a home sleep study using the SNAP® Diagnostics Model 8 Ventilatory Effort Recorder device was used. The results of these recordings were analyzed by SNAP® Diagnostics, Inc. The qualifications of these analysts are not specified beyond being "SNAP® Diagnostics staff algorithms."
4. Adjudication Method for the Test Set
There was no explicit adjudication method mentioned for the bed partner reported outcome (VAS score) as it was considered an "objective scoring" from the bed partner. For the AHI scores from the home sleep study, the analysis was performed by a single entity (SNAP® Diagnostics, Inc.), suggesting a single read rather than a multi-reader adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly done as typically understood in the context of imaging analysis. The primary efficacy endpoint was a patient-reported outcome (via bed partner) using a Visual Analog Scale, not a diagnostic interpretation by multiple human readers. The study compared the device's efficacy to baseline performance (single group compared to baseline) and also contextualized its efficacy against published data from a predicate device's clinical study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a physical intervention for snoring, not an algorithm or diagnostic tool. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
The primary ground truth for efficacy was:
- Bed Partner's Visual Analog Scale (VAS) 0-10 score assessment of the Study Subject's snoring severity, considered an observer-reported outcome (eORO).
Secondary ground truths were:
- Study Subjects' self-reported Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index (patient-reported outcomes, ePRO).
- Home sleep study results (SNAP® Diagnostics) for AHI score and audio files for snoring noise events, analyzed by SNAP® Diagnostics algorithms.
8. The Sample Size for the Training Set
This document describes a clinical study for device clearance, not the development of an AI algorithm with distinct training and test sets. Therefore, there is no "training set" in the context of machine learning. The clinical study described in Section 807.92(b)(2) is the primary clinical evaluation for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
As there was no training set in the AI/ML context, this question is not applicable. The clinical study described served as the validation (test) set for the device's performance.
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