(78 days)
The Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older.
The Advanced Anti Snoring Device 4.0 is designed to reduce snoring by gently repositioning the lower jaw forward, which opens the airway and allows for smoother airflow during sleep. By adjusting the position of the lower jaw, the device helps prevent the throat tissues from collapsing and blocking airflow, which is a common cause of snoring. The 4.0 version is customizable, allowing users to set the lower jaw advancement up to 6mm, providing a personalized fit for maximum comfort and effectiveness. This forward positioning also reduces vibrations in the airway, which are often responsible for the snoring sound.
The provided FDA 510(k) clearance letter and summary for the Advanced Anti Snoring Device 4.0 (K250482) explicitly state "Performance Testing - Clinical: Not Applicable." This indicates that no human clinical studies were performed to demonstrate the device's performance in reducing snoring.
Therefore, based solely on the provided document, I cannot fulfill most of your request as the information regarding clinical performance, expert ground truth, sample sizes for test sets, MRMC studies, or training sets is not present. The device's clearance is based on substantial equivalence to a predicate device (K233850) through non-clinical testing.
However, I can extract the information related to acceptance criteria (implied by the comparison to the predicate) and the non-clinical studies performed.
Here's a breakdown of what can be inferred and what cannot be provided from the given text:
What Can Be Inferred/Extracted from the Document:
- Acceptance Criteria (Implied by Predicate Equivalence): The primary "acceptance criteria" here is the demonstration of substantial equivalence to the predicate device (Difiney Anti Snoring Device, K233850) based on shared technological characteristics and non-clinical performance. The device must meet the regulatory requirements for an intraoral device for snoring.
- Reported Device Performance: The device's performance is not reported in terms of clinical efficacy in reducing snoring, but rather in meeting material and mechanical specifications.
- Non-Clinical Studies: Biocompatibility and physical properties testing.
What Cannot Be Provided from the Document (as "Not Applicable" or Not Mentioned):
- A table of acceptance criteria and reported device performance related to snoring reduction (as no clinical performance data is provided).
- Sample sizes used for a test set (no clinical test set described).
- Data provenance for a test set.
- Number of experts used to establish ground truth for a test set.
- Qualifications of those experts.
- Adjudication method for a test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Effect size of human readers improving with AI vs. without AI assistance.
- If a standalone (algorithm only) performance was done.
- The type of ground truth used (clinical outcomes).
- The sample size for the training set (no AI/ML algorithm mentioned requiring a training set).
- How the ground truth for the training set was established.
Summary Based on Provided Document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Intended to help reduce snoring in people 18 years of age or older. | "The Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older." (Stated in Indications for Use, demonstrating conformance to the predicate's intended use.) |
| Mechanism of Action | Reduces snoring by gently repositioning the lower jaw forward, opening the airway, and allowing smoother airflow during sleep, preventing throat tissues from collapsing and blocking airflow. | "helps reduce snoring by moving the lower jaw forward to open your airway to improve breathing allowing air to flow freely without the unhealthy and annoying sound of snoring." (Matches predicate's mechanism) |
| Materials | Must use materials comparable to the predicate (Polycarbonate resin, Ethylene vinyl acetate copolymer). | Uses Polycarbonate resin and Ethylene vinyl acetate copolymer. |
| Desired Characteristics | Home use, heat sensitive/moldable, adjustable jaw advancement position. | Home use, heat sensitive/moldable, adjustable jaw advancement position. |
| Physical/Mechanical | Custom-fitted intraoral device, repositions mandible anteriorly, reusable. | Custom-fitted intraoral device, repositions mandible anteriorly, reusable. (Similar to predicate) |
| Mandibular Advancement | Predicate offers up to 4mm advancement in 1mm increments. Subject device offers up to 6mm advancement in 1mm increments. (Difference assessed not to impact safety/effectiveness). | Up to 6mm at 1mm increment. |
| Design | Predicate has a small anterior protrusion. Subject device omits this for comfort. (Difference assessed not to affect safety/effectiveness). | Small anterior protrusion present (referring to the subject device having one, but the text "Different 2" says "No anterior protrusion" for subject device and "Small anterior protrusion present" for predicate. This seems like a typo in the table itself. Assuming the text description of the difference is correct: Small anterior protrusion absent). |
| Manufacturing Process | Injection molding. | Injection molding. |
| Sterility | Non-sterile. | Non-sterile. |
| Biocompatibility | Must meet ISO 10993 standards. | "Bio-compatibility assessment was conducted in accordance with ISO 10993-1..." and passed. |
| Physical Properties of Materials | Materials must meet performance tests for flexural strength, flexural modulus, tensile strength, elongation at break, water absorption, melting temperature, and density. | Materials passed these performance tests. |
2. Sample Size Used for the Test Set and Data Provenance:
* N/A. The document explicitly states "Performance Testing - Clinical: Not Applicable." The clearance is based on non-clinical testing and substantial equivalence to a predicate device.
* The non-clinical tests (biocompatibility, physical properties) are typically conducted on material samples or device prototypes, not human subjects, and thus "sample size" in the context of a clinical test set is not relevant here.
* Data Provenance: Not applicable for clinical data. For non-clinical tests, the tests were conducted by the manufacturer, Fissiontech LLC. The country of origin for the device manufacturing is likely China, given the correspondent's location, but this is not explicitly stated for the testing location itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
* N/A. As no clinical performance testing or "test set" for efficacy was conducted or reported, no experts were used to establish ground truth for clinical outcomes in this context.
4. Adjudication Method for the Test Set:
* N/A. No clinical test set or adjudication process for human data was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
* N/A. No clinical studies were reported, and the device is not an imaging AI product that would typically undergo MRMC studies.
6. If a Standalone Performance Study was done (e.g., algorithm only without human-in-the-loop performance):
* N/A. The device is a physical intraoral device, not an algorithm. No standalone performance study related to AI/ML was relevant or conducted.
7. The Type of Ground Truth Used:
* For the non-clinical testing, the "ground truth" was established by standardized test methods and specifications (e.g., ISO 10993 for biocompatibility, and various physical property tests for material characteristics). The device's conformance to these predefined standards served as the "ground truth" for material and manufacturing quality.
* For clinical efficacy in snoring reduction, no ground truth was established or presented in this document.
8. The Sample Size for the Training Set:
* N/A. This device does not incorporate AI/ML, so there is no training set.
9. How the Ground Truth for the Training Set Was Established:
* N/A. No training set exists.
In conclusion, the FDA 510(k) clearance for the Advanced Anti Snoring Device 4.0 was granted based on demonstrably meeting all non-clinical design specifications and showing substantial equivalence to a legally marketed predicate device, rather than through clinical performance testing for snoring reduction.
§ 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.”