(116 days)
The Respire Blue Scries - EF is indicated to treat mild to moderate OSA (Obstructive Sleep Apnea)
The Respire Blue Series – EF (Endurance Frameworks) – is available with a hard device fitting surface. The hard surface consists of Acrylic (side plates / trays) and chrome - Wironit material (upper / Palatal and lower / Lingual plates / trays). Refer to Figure 1 Representative Drawing. The device is retained with ball and clasps which are used to hold elastic bands which guide the jaw to the desired position. In addition there are expansion screws inside the Acrylic side plates / trays that allows for device expansion based on patient needs.
The upper and lower components are connected by an adjustable hinge, thus the patient can open and close the mouth while wearing the appliances
The provided text describes the Respire Blue Series - EF intraoral device, indicated for treating mild to moderate Obstructive Sleep Apnea (OSA). The 510(k) submission (K152292) is for a modification to a previously cleared device (K111207), specifically the material used for the top and bottom plates/trays.
Based on the provided text, the acceptance criteria and study information can be summarized as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993 Standards | "The results of testing determined that the material didn't cause skin irritation or allergenic sensitization." |
| Cytotoxicity | MEM Elution testing | "The testing passed with a reactivity of 0 (zero) or none." |
| Material Integrity (Strength) | Specimen elongation and load-bearing force to break | "The amount of energy shown in the results, still far exceeds the amount of energy required by biting to create such a failure which occurred at an average of 275.6 Ibf using five (5) sample devices. Thus, the proposed Wironit/Acrylic parts are sufficient to survive a load exposure exerted by a human oral cavity." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the Material Integrity testing, five (5) sample devices were used.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It is assumed to be part of the manufacturer's internal testing as described in the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention the use of experts to establish ground truth for the non-clinical tests described. The tests appear to be laboratory-based material science tests.
4. Adjudication Method for the Test Set
- This information is not applicable as the described tests are laboratory-based material science tests, not clinical studies involving interpretation by multiple 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
- No MRMC comparative effectiveness study was done. This device is a physical intraoral device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. This device is a physical intraoral device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility and cytotoxicity, the "ground truth" is defined by the ISO 10993 standards and the specific reactivity thresholds of the MEM Elution test.
- For material integrity, the "ground truth" is established by the mechanical properties (elongation, load-bearing force) of the material compared to a benchmark (the predicate device and the force exerted by a human bite).
8. The sample size for the training set
- A "training set" is not applicable for the type of non-clinical tests described for this physical device. These are material characterization and performance validation tests, not machine learning model training.
9. How the ground truth for the training set was established
- This information is not applicable as there is no training set for a machine learning model.
§ 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.”