(110 days)
Reduce nighttime snoring and/or mild to moderate obstructive sleep apnea by repositioning of the mandible.
The device consists of a lower tray fitted over the lower teeth, an upper tray over the upper teeth, and a mechanism to attach the lower to the upper tray. The device allows the practitioner to determine the advancement of the mandible and the vertical opening for desired results. This technology platform consists of a stylus, slider, and the channels into which they are placed; these parts are identical in both models.
The device has a 10 mm long channel in the lower tray behind the anterior teeth that is perpendicular to the patient's tongue. This allows the upper component, which locks into the channel, to provide lateral excursion for the patient's comfort. Prior to final insertion the upper and lower trays are connected together by keying the stylus into the lower channel. The device's upper component consists of a 16 mm long titanium channel into which a nine-position latched slider will let the practitioner place the stylus in the optimum position. Both the slider and the stylus are placed into the channel's frontal opening and securely locked into place by tension attachment.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., reduction in AHI, success rates, or statistical improvements). Instead, the substantial equivalence comparison focuses on design attributes and intended use compared to predicate devices. The "reported device performance" is implicitly established by demonstrating these comparable design features and intended use.
Therefore, the table below reflects the comparison of attributes as presented in the document, which serves as the basis for determining substantial equivalence rather than quantitative performance against a pre-defined acceptance criterion.
| Attribute | Acceptance Criteria (based on predicate device features) | Reported Device Performance (Silent Partner) |
|---|---|---|
| Intraoral device | Yes (must be an intraoral device) | Yes |
| Reduce snoring | Yes (must reduce snoring) | Yes |
| Reduce obstructive sleep apnea | Yes (must reduce obstructive sleep apnea) | Yes |
| Removable device | Yes | Yes |
| Custom fit | Yes | Yes |
| Adjustable forward movement | Yes | Yes |
| Adjustable vertical movement | Not necessarily required by all predicates, but demonstrated by some | Yes (differentiator from some predicates) |
| Separate trays | Yes | Yes |
| Holds lower jaw forward | Yes | Yes |
| Permits lateral jaw movement | Yes | Yes |
| Permits vertical jaw movement | Yes (demonstrated by some predicates) | No (differentiator from some predicates) |
| Upper and lower trays can be separated by patient | Yes (demonstrated by some predicates) | Yes |
| Permits patient to breathe through mouth | Yes | Yes |
| Specialized tools needed | No (demonstrated by some predicates) | No |
| Vacuum formed trays (Model A) | Yes (comparable material/manufacturing method) | Yes |
| Thermoplastic trays (Model B) | Yes (comparable material/manufacturing method) | Yes |
| Ti stylus and critical parts (Note: This is a material difference, not a functional criterion in the same way) | No (not present in predicates listed) | Yes (unique feature) |
Study that proves the device meets the acceptance criteria:
The provided 510(k) summary does not describe a specific clinical study with performance metrics demonstrating that the "Silent Partner" device meets quantitative acceptance criteria. Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices (TOA, TAP, OASYS) based on:
- Intended Use: The Silent Partner shares the identical intended use of reducing snoring and mild to moderate obstructive sleep apnea by repositioning the mandible.
- Technological Characteristics/Design: The device's design features (e.g., intraoral, removable, custom fit, adjustable forward movement, separate trays, holds lower jaw forward, permits lateral jaw movement, permits patient to breathe through mouth) are compared to the predicate devices. Differences are noted (e.g., adjustable vertical movement, permitting vertical jaw movement, Ti stylus and critical parts), but these differences are either considered to not raise new questions of safety or effectiveness, or are improvements that do not change the fundamental mechanism of action.
- Materials: The device uses vacuum-formed or thermoplastic trays, similar to the predicate devices. The use of a Titanium (Ti) stylus and critical parts is a material difference but is not presented as raising new safety or efficacy concerns.
The conclusion states: "To the best of our knowledge, the device is substantially equivalent to the predicate devices, and no additional risks are created." This statement, coupled with the detailed comparison table, is the "proof" presented in this 510(k) summary for meeting the criteria of substantial equivalence, which is the basis for market clearance for Class II devices like this.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable. This 510(k) summary does not report on a specific test set used to generate performance data for the Silent Partner device. The submission relies on a comparison to predicate devices, not on new clinical data.
- Data provenance: Not applicable. No clinical data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set or expert adjudication process is described.
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 intraoral appliance, not an AI or imaging-based diagnostic tool. No MRMC study was conducted or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an intraoral appliance; it is not an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No new ground truth data was generated or used in this 510(k) submission. The "ground truth" for the comparison is the established performance and safety profile of the predicate devices.
8. The sample size for the training set
- Not applicable. This 510(k) summary does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. No "training set" and associated ground truth establishment are relevant to this submission.
§ 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.”