(529 days)
SmartGuard Anti-Snore Device is indicated for use on adult patients 18 years or older as an aid for the reduction of snoring.
The SmartGuard® Anti-Snore Device is an intra-oral device composed of two independent injection molded thermoplastic (Polycarbonate) trays, over molded with thermoforming resin (EVA). One tray is for the maxillary arch, labeled "Upper", and one tray is fitted to the mandibular arch, labeled "Lower". Both trays are custom fitted by the end user via "Boiland-Bite" process at home. A molding aid is included in the packaging to assist the user in the customization of the trays. The molding aid is constructed with the same Polycarbonate material as the upper and lower trays, as well as the Advancement Bars. Once the trays are molded to the user's teeth, the trays are connected via the insertion of Advancement Bars, which are available in 6 sizes, varying in length by 1mm. The Advancement Bars interlock with the mandibular and maxillary trays and holds the mandible forward which improves the ability to exchange air and decreases air turbulence, a causative factor in snoring. Because the trays are independent, the user can articulate vertically, allowing for greater airflow and comfort. As with all listed predicate devices, SmartGuard® Anti-Snore Device is a Mandibular Advancement Device (MAD) and is easily adjusted by the user to allow for up to 6mm of protrusion. The user can interchange the various sizes of Advancement Bars to find the size that comfortably advances the mandible and reduces snoring.
The SmartGuard Anti-Snore Device is substantially equivalent to predicate devices in terms of its technological characteristics, materials, and intended use as an aid for the reduction of snoring. The device itself is a Mandibular Advancement Device (MAD) that advances the lower jaw to increase pharyngeal space and alleviate snoring. It is made from polycarbonate and ethylene vinyl acetate copolymer, materials commonly used in similar devices, and is custom-fitted by the user at home via a "boil-and-bite" process.
Here's an overview of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provided does not contain a specific table of quantitative acceptance criteria for the SmartGuard Anti-Snore Device's effectiveness in reducing snoring, nor does it present direct performance metrics for the device itself in terms of snoring reduction. Instead, the substantial equivalence argument relies heavily on its similarity to legally marketed predicate devices.
The acceptance criteria are implicitly met by demonstrating that:
- The device has similar indications for use to predicate devices: "SmartGuard Anti-Snore Device is indicated for use on adult patients 18 years or older as an aid for the reduction of snoring."
- The device shares similar technological characteristics (e.g., MAD mechanism, materials, custom fitting method, adjustability) with predicate devices.
- The device meets biocompatibility standards (e.g., ISO 10993-1) for its materials, which are identical to those in predicate devices and a previously cleared device from the same submitter.
- Risk analysis (ISO 14971:2007) was conducted, and identified risks were addressed.
- Usability testing (Human Factors and Usability Engineering) confirmed ease of use and understanding of labeling by laypersons.
- Non-clinical bench testing confirmed physical properties of materials met device specifications.
2. Sample Size Used for the Test Set and Data Provenance:
- Human Factors and Usability Engineering (HFE/UE) study: The document refers to a "summary report for the Usability Test contained in section 21." However, the provided excerpt does not include section 21 or provide details on the sample size for this test.
- For other aspects, such as biocompatibility and material testing, specific sample sizes for test sets are not mentioned. The document relies on established standards and the identity of materials with existing cleared devices.
- Data Provenance: Not explicitly stated for any of the tests, but the nature of the studies (e.g., HFE/UE, non-clinical bench testing) suggests these were conducted by or on behalf of SmartGuard Rx Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not detail the use of experts to establish 'ground truth' in the context of device performance for snoring reduction. The clinical effectiveness for snoring reduction is inferred from substantial equivalence to predicate devices that are already cleared for this indication.
- For the Usability Engineering study, the "ground truth" would be the observed user interactions and comprehension. No specific number or qualification of experts defining this 'ground truth' is provided, beyond the implication that the study was designed and evaluated by human factors professionals.
4. Adjudication Method for the Test Set:
- No information is provided regarding an adjudication method for any specific test set. This type of method is typically employed in clinical trials or studies where subjective assessments (e.g., image interpretation, symptom severity) require expert consensus, which does not appear to be the primary method for demonstrating equivalence in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical testing was performed in association with this submission."
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:
- This device is a physical intra-oral appliance, not an algorithm or AI system. Therefore, the concept of an "algorithm only" or "standalone" performance study in that context is not applicable. The device's performance is intrinsically tied to its physical interaction with the user's anatomy.
7. The Type of Ground Truth Used:
- For regulatory clearance, the "ground truth" for the SmartGuard Anti-Snore Device is its substantial equivalence to predicate devices, meaning it shares similar indications, technological characteristics, materials, and safety profiles.
- For the Human Factors and Usability Engineering study, the "ground truth" would be the actual observed user behavior and comprehension of the device's labeling and instructions for use, aiming to ensure safe and effective home use by laypersons.
- For biocompatibility and material testing, the "ground truth" is adherence to established international standards (e.g., ISO 10993-1, ISO 527, ISO 178, ISO 62) and material identity to previously cleared devices.
8. The Sample Size for the Training Set:
- This information is not applicable. The SmartGuard Anti-Snore Device is a physical medical device. It does not involve machine learning or AI that would require a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" in the context of this device's 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.”