(211 days)
The Slide is for use to reduce night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The Slide™ is a prescribed intraoral device worn while sleeping in order to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA). Snoring and OSA is caused by partial or complete closure of the muscle in the upper airway (pharyngeal space). The device uses two splints joined by two parallel sliding connectors that position the lower iaw forward and open from its normal location. This forward protrusion opens up the upper airway reducing obstructions during sleep. The prescribing dentist determines the exact repositioning of the lower bite. Its simplistic design allows for the forward displacement to be adjusted without the use of specialized tools using different sized spacers. Adjustments are initially made in the prescribing dentist office; further adjustments can be made depending on relief of symptoms and comfort while sleeping.
The provided text is a 510(k) Premarket Notification Summary for "The Slide," an intraoral device for snoring and obstructive sleep apnea. It outlines the device's characteristics, comparison to a predicate device (SomnoDent G2), and performance data.
However, the document does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device for which such detailed performance metrics, ground truth establishment, and clinical study designs (MRMC, standalone) would be highly relevant.
The document makes it clear that clinical testing was NOT required and that substantial equivalence was based upon "benchtop performance testing" and comparison to a predicate device. This is a traditional medical device clearance, not an AI/ML device clearance that would typically involve the kind of rigorous performance evaluation against established ground truth as outlined in your request.
Therefore, many of your requested points cannot be answered from the provided text because the study type (benchtop mechanical testing, not a clinical study assessing diagnostic or therapeutic accuracy in humans based on ground truth data) does not lend itself to those questions.
Here's a breakdown based on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance (as per the provided text for a mechanical device):
The "acceptance criteria" detailed in the document primarily revolve around mechanical integrity and biocompatibility, not performance metrics related to diagnostic accuracy or AI assistance.
| Acceptance Criteria (Benchtop/Mechanical) | Reported Device Performance |
|---|---|
| Material biocompatibility in compliance with ISO 10993-1:2018 | Established to be in compliance with ISO 10993-1:2018. |
| Maximum force the device can withstand (compared to forces in patient's mouth) | The mean peak force the device can withstand is 10 standard deviations above the acceptance criteria. (This indicates it far exceeds the minimum required strength). |
| Substantial equivalence to predicate device (SomnoDent G2) | Demonstrated through comparison of indications for use, intended use, design, and materials (Table 1 and Section 7). |
Study Details (Based on the Provided Text):
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical data for an AI/algorithm. The performance data is primarily benchtop mechanical testing. The document states, "Mechanical testing was performed to verify device functionality by assessing the maximum force the device can withstand..." No human test subjects or clinical data are described.
- Data Provenance: Not applicable for clinical data. The context is benchtop testing of the device itself.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the sense of expert consensus on patient conditions (e.g., diagnosis of sleep apnea from physiological data), was not established for this type of testing. The "truth" here is engineering specifications and material properties.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical test set requiring adjudication.
-
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. An MRMC study was explicitly not done. The document states: "Clinical testing was not required to demonstrate the safety and effectiveness of The Slide. Instead, substantial equivalence is based upon benchtop performance testing." This device is a physical intraoral device, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this regulatory submission was compliance with engineering standards (ISO 10993-1:2018 for biocompatibility) and achieving specific mechanical properties (withstanding force) that were deemed sufficient compared to the predicate device and expected in-mouth forces. Clinical ground truth was not part of this evaluation.
-
The sample size for the training set:
- Not applicable. This device is not an AI/ML model that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. There was no training set for an AI/ML model.
In summary, the provided document details the regulatory clearance of a physical medical device (intraoral snore/sleep apnea appliance) based on engineering performance and substantial equivalence to a predicate, rather than the performance evaluation of an AI/ML diagnostic or assistive algorithm. Therefore, many of your questions regarding AI-specific criteria are not addressed by this document.
§ 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.”