(90 days)
Classic is a Mandibular Advancement Device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring in adults.
Classic device is an intraoral device specially indicated for the treatment of snoring and obstructive sleep apnea syndrome. Its design makes it simple to use and comfortable to wear. It is intended for single-patient use by adults who are 18 years or older.
Classic device consists of two splints united to each other by a screw that allows controlled advancement of the mandible by the increase of the muscular tone at the airway level. Consequently, the flow of air through the upper airway is increased, and reducing snoring and apnea events.
The maximum protrusion of Classic arch form is 10 mm, measuring from patient's plate. This device needs an external controlling component such as screwdriver included in the kit. The device is according arches, maximizes tongue space and allow open, close and laterality movements during wear. These movements can be personalized by the doctor.
Each Classic device has the following components:
- Upper splint
- Lower splint
- Activation key
- Guide (Bar)
- OrthoApnea screw
This document is an FDA 510(k) Premarket Notification for the "Classic" Mandibular Advancement Device (MAD). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a specific performance metric against a set of acceptance criteria derived from a novel clinical study.
Therefore, many of the requested elements regarding acceptance criteria, study design, expert involvement, and ground truth for demonstrating device performance are not applicable in the context of this 510(k) submission document. The submission relies heavily on non-clinical testing and comparison to predicates to assert safety and effectiveness.
Here's a breakdown of the requested information based solely on the provided document:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy) derived from a specific clinical study aimed at proving the device meets those criteria. Instead, the "acceptance criteria" for a 510(k) submission are fundamentally about demonstrating substantial equivalence to a predicate device.
The closest one gets to "performance" here is demonstrating adherence to established standards and similar characteristics to the predicate.
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (from "Table 1: Device Comparison") |
|---|---|---|
| Intended Use | Must be same as or similar to predicate | To reduce or alleviate nighttime snoring and mild to moderate obstructive sleep apnea (OSA). (Same as predicates) |
| Material | Must be same as or similar to predicate (biocompatible and safe) | Polymer PET G and TPU, Polymethylmethacrylate, Stainless steel and Titanium alloy (Similar; considered "Yes" for SE) |
| Fixed/Removable | Must be same as predicate | Removable (Same as predicates) |
| Sterile | Must be same as predicate | Non-sterile (Same as predicates) |
| Mandibular adjustment | Must be same as or similar to predicate's mechanism | Customized by physician or dentist. (Same as predicates) |
| Mandibular adjustment range | Must be comparable to predicate (with justification for differences) | Up to 10.0 mm (Slightly larger than predicate's 7.0 mm, but deemed substantially equivalent) |
| Compliance with Standards | Must comply with relevant ISO and ASTM standards for medical devices and materials. | Complies with ISO 20795-2, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 5832-3, ISO 5832-1. (Reported compliance) |
| Bench Testing Performance | Device properties (flexural, tensile) should meet expected performance for the material. Biocompatibility must be demonstrated. | Flexural properties (ISO 178:2010), Tensile properties (ASTM D638-02) were determined. Biocompatibility evaluation in accordance with ISO 10993-1:2009. (Testing performed, results implicitly satisfactory for SE) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for a physical medical device (intraoral device) and relies on non-clinical (bench) testing and comparison to predicates, not a clinical test set of patient data with a defined sample size as would be used for an AI/software device.
- Data Provenance: The bench testing likely occurred at the manufacturer's facility or a certified lab. The document does not specify the country of origin for the data or whether it was retrospective or prospective, as it's not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No clinical test set with human data requiring expert ground truth establishment was used in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set with human data requiring adjudication was used.
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 is a physical device, not an AI or software-as-a-medical-device (SaMD) product. No MRMC study was performed or required for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For the non-clinical testing performed, the "ground truth" would be the established physical and chemical properties of the materials and the performance specifications of the device components as defined by the international standards (e.g., ISO, ASTM). Biocompatibility is assessed against the absence of toxic reactions as per ISO standards. There is no patient-level "ground truth" for disease state or outcomes.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this device. It's not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.”