Search Results
Found 1 results
510(k) Data Aggregation
(44 days)
The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.
The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is a removable intraoral device used for treating night time snoring and mild to moderate obstructive sleep apnea. It consists of two customized fabricated chrome cobalt (Vitallium 2) frameworks that conform to the patient's dentition in the upper and lower jaws and are connected bilaterally via a stainless steel telescoping Herbst device. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to improve the patient's ability to breathe during sleep without obstruction of the pharyngeal airway. The device is customized according to the prescription of the prescribing dentist for each patient. It has an adjustment mechanism enabling the amount of mandibular advancement to be set or altered by the dentist. The maximum protrusion and allowable increments of adjustment are 5mm.
The provided text describes the Somnowell Mandibular Advancement Appliance (Somnowell MAA) and its submission for FDA clearance. The document focuses on demonstrating substantial equivalence to a predicate device, TheraSom-CAST (K113516), rather than on presenting a study with specific acceptance criteria and performance metrics for the Somnowell MAA itself.
Therefore, many of the requested details about a study proving the device meets acceptance criteria, such as clinical performance, sample sizes, expert ground truth, adjudication methods, and MRMC studies, are not available in this document. The submission explicitly states "Clinical testing - No clinical data is included in this submission."
However, I can extract information regarding non-clinical testing (bench testing) and the general claims of substantial equivalence based on technological characteristics and performance compared to the predicate.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no specific quantitative acceptance criteria or clinical performance metrics for the Somnowell MAA are provided, I'll list the general performance claims and the results of the bench testing. The "acceptance criteria" here are implicitly linked to demonstrating equivalence to the predicate's performance in mechanical tests.
| Acceptance Criterion (Implicit) | Reported Device Performance (Somnowell MAA) |
|---|---|
| Withstand mechanical forces without distortion or fracture (Static Arch-Compression Test) | Test results demonstrated that Somnowell MAA is capable of withstanding the applied horizontal forces without distortion or fracture. |
| Fixing part joints capable of withstanding forces without distortion or breakage | Test results demonstrated that the fixing part joints were capable of withstanding the applied horizontal forces without distortion or breakage. |
| Biocompatibility (ISO 10993-5 Cytotoxicity Test) | Results demonstrated no evidence of causing cell lysis or toxicity related to Somnowell's raw material. No risk is raised by the used raw material. |
| Mechanical performance for intended use (implied, by comparison to predicate) | "Test results have proven that the device performance and its intended use are as safe and as effective as its predicate devices." "Somnowell MAA is as safe and as effective for its intended use and performs as well as the predicate devices and thus considered to be substantially equivalent to its predicate devices." The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to improve the patient's ability to breathe during sleep without obstruction of the pharyngeal airway. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Bench Testing): Not specified.
- Data Provenance: Not specified, but generally refers to laboratory bench testing conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was bench testing, not a clinical study requiring expert diagnosis or ground truth establishment in that context.
4. Adjudication method for the test set:
- Not applicable for bench testing.
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:
- No MRMC clinical study was conducted. The submission explicitly states "Clinical testing - No clinical data is included in this submission." This device is a physical appliance, not an AI or imaging diagnostic tool, so an MRMC study is not relevant to its type of evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an algorithm or AI device. Standalone performance as commonly understood in AI/software evaluation is not applicable.
7. The type of ground truth used:
- For the bench tests, the "ground truth" would be the engineering specifications and expected mechanical properties, tested against established laboratory methods. For biocompatibility, it's compliance with ISO 10993-5 (absence of cytotoxicity).
8. The sample size for the training set:
- Not applicable, as this is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1