(420 days)
The BFit Intraoral Appliances are likely to reduce snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or older.
Optionally, the DentiTrac Micro-Recorder may be incorporated into the Bfit device. The DentiTrac is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac System.
The Bfit Intraoral Appliances are mandibular advancement devices which function by holding the jaw in a forward position during sleep (the principle of operation). The forward placement moves the tongue and pharyngeal tissue into a position to maintain an open airway, which allows the passage of more air per breath and helps in the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA) - the intended effect. The Bfit Sleep and Bfit Engage use mild elastic pull during the different stages of sleep where muscle activity is lost. In addition, both models of the oral appliance may be provided to the patient with an embedded DentiTrac micro-recorder used to capture the patient's compliance to the prescribed oral appliance therapy. Each oral appliance is custom-fit to the patient. The Bfit is available in four possible configurations which differ only in connecting mechanism and whether a DentiTrac is installed: Bfit Sleep (elastics), Bfit Sleep with DentiTrac, Bfit Engage (tension springs), and Bfit Engage with DentiTrac.
The provided text does not contain information about the acceptance criteria and performance of the device in the context of clinical studies to prove its effectiveness in reducing snoring or OSA.
The document is a 510(k) summary for the Bfit Intraoral Appliances, which focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance testing and biocompatibility testing. It does not present clinical studies with human participants to establish clinical efficacy or define acceptance criteria for such efficacy.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance (for clinical efficacy).
- Sample size used for the test set and data provenance (for clinical efficacy).
- Number of experts and qualifications for ground truth (for clinical efficacy).
- Adjudication method (for clinical efficacy).
- MRMC comparative effectiveness study results.
- Standalone algorithm performance (as this is a physical device, not an AI algorithm).
- Type of ground truth used (for clinical efficacy).
- Sample size for the training set (for clinical efficacy).
- How ground truth for the training set was established (for clinical efficacy).
What the document does provide regarding testing and criteria is related to the device materials and mechanical performance:
1. A table of acceptance criteria and the reported device performance (for non-clinical aspects):
| Test Performed | Test Method/Applicable Standard | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity (MEM Elution Study# 1082899-S01) | MEM Elution STP0032 Rev 10 ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | No greater than 2 (Mild) | 0 = No reactivity (Pass) |
| Sensitization (Kligman Maximization Test Study# 1082901-S01) | Kligman Maximization Test ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity | 0 No reaction | 0 = No reaction (Pass) |
| Irritation (Primary Oral (Buccal) Irritation Test-Acute Exposure Study# 1082900-S01) | Primary Oral (Buccal) Irritation Test-Acute Exposure ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity | 0 No irritation | 0 = No irritation (Pass) |
In addition, the following non-clinical tests were performed by the material manufacturer, and "Bench testing to ensure durability of the appliance under normal wearing and cleaning conditions was also performed. The appliance passed all testing." No specific numerical acceptance criteria or performance metrics are detailed in the provided text for these tests:
- Tensile strength (ASTM D-638)
- Flexural Strength (ASTM D-790)
- Flexural Modulus of Elasticity (ASTM D-790)
- Compressive Strength (ASTM D-695)
- Density (ASTM D-792)
- Melt Flow Rate (ASTM D-1238)
- Melting Point (ASTM D-3418)
- Vicat Softening Point (ASTM D-1525)
2. Sample sized used for the test set and the data provenance: Not applicable to clinical efficacy in this document. For biocompatibility, the sample sizes are embedded within the "Study#" identifiers but not explicitly stated as number of units tested. Data provenance is implied by the testing standards (e.g., ISO, ASTM).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this document focuses on non-clinical and biocompatibility testing, not expert-adjudicated clinical outcomes.
4. Adjudication method for the test set: Not applicable for non-clinical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is a physical medical device, not an AI algorithm requiring MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a physical medical device, not an algorithm.
7. The type of ground truth used: For biocompatibility, the ground truth is based on established biological and physical test standards (e.g., ISO 10993, absence of reactivity/irritation/sensitization). For the other non-clinical tests, it is based on the material properties and durability assessments.
8. The sample size for the training set: Not applicable, as this is not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
§ 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.”