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510(k) Data Aggregation
(256 days)
FELLMAR COMPANY
The Snorkel is used to reduce tongue induced airway obstructions. The Snorkel is intended for use in patients, for the treatment of mild to moderate obstructive sleep apnea.
The Snorkel is an oral mandibular advancement device whose function is to artificially protrude the chin (mandible) forward so as to pull the tongue away from the back of the throat, thereby reducing tongue-induced airway obstruction.
The Snorkel device is custom-made and fitted based on dental impressions and used by the patient during sleep. The single mouth piece fits snugly onto the upper and lower crowns of the patient's teeth. As the patient falls asleep, thus relaxing their mandible, a silicon band provides tension such that the mandible is pulled forward along with the tongue.
The provided document describes "The Snorkel," a mandibular repositioning device for reducing snoring and treating mild to moderate obstructive sleep apnea. The submission for this device is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than providing extensive clinical trial data for new acceptance criteria.
Therefore, the following information is extracted from the document:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission, there are no explicit "acceptance criteria" defined in the typical sense of a clinical trial with performance metrics. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, K955503 (Adjustable PM Positioner), across various characteristics.
| Acceptance Criteria (Implicit from Substantial Equivalence Basis) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Indications for Use Equivalence | The Snorkel is intended for use in patients, for the reduction of snoring and to treat mild to moderate obstructive sleep apnea, which are the same indications as the predicate. |
| Technological Characteristics Equivalence | "Like the Adjustable PM Positioner (K955503), the Snorkel is a mouth splint appliance comprised of an acrylic upper body and an acrylic lower body, which are coupled together to push the lower jaw forward." The Snorkel's function "is to artificially protrude the chin (mandible) forward so as to pull the tongue away from the back of the throat, thereby reducing tongue-induced airway obstruction." |
| Material Equivalence | Biocompatibility assessment performed; device is biocompatible "based on the similarity of the materials of construction to the predicate device." |
| Performance "Specifications" Equivalence | "The Snorkel meets the same specifications as set for the predicate device." (No specific quantitative specifications are provided in the document.) |
| Safety | Risks and mitigating controls identified by the FDA for mandibular repositioning devices have been addressed. Adequate warnings and precautions are found in the "Instructions for Use" manual. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No human clinical study was conducted for this 510(k) submission to evaluate the safety or effectiveness of The Snorkel device itself. The evaluation relied on non-clinical testing and comparison to the predicate device.
- Data Provenance: Not applicable for a "test set" in the context of clinical performance. The data provenance would be from internal non-clinical testing (physical properties, biocompatibility) and regulatory guidelines regarding risk assessment for such devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. No "ground truth" was established based on expert review of a test set for this device in the context of a clinical performance study. The assessment was based on engineering design, material characteristics, and comparison to a predicate device.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. As no clinical test set was used, there was no need for an adjudication method by experts.
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:
- MRMC Study Done: No. This is a physical medical device (mandibular repositioning device), not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence was the established safety, effectiveness, and technological characteristics of the predicate device (Adjustable PM Positioner, K955503), as well as the successful completion of non-clinical tests (physical properties, biocompatibility) and a risk assessment. There was no clinical ground truth established for The Snorkel itself through direct human clinical testing.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. There was no "training set" of data in the context of machine learning or clinical trials for this device.
9. How the ground truth for the training set was established:
- How Ground Truth for Training Set was Established: Not applicable. No training set was used.
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