(1 days)
The airVata™ sleep appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The airVata™ sleep appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.
The airVata™ sleep appliance is a mandibular advancement device. It holds the mandible in a protrusive position as determined by a trained dentist. The device consists of upper and lower splints (trays), which are additive manufactured using a biocompatible light curable resin. Connectors, made of a biocompatible synthetic polymer with injection molding technology attach the upper and lower splints to maintain the forward position of the lower jaw. The device is adjustable in 1.0 mm increments by using different lower trays supplied with the device. The connectors are attached after the upper and lower splints (trays) are manufactured. The Subject device is a single patient, non-sterile, prescription-only device. It is to be used only by the patient for whom it is custom designed. It is to be worn during sleep and may be removed by the patient at any time.
This document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of a new medical device (airVata™) to a legally marketed predicate device (EndSnorZ™ Sleep Appliance). It does not describe a study proving the new device meets acceptance criteria in the way a clinical trial or algorithm performance study would. Instead, it focuses on non-clinical testing and comparison to an existing device to demonstrate similar safety and effectiveness.
Therefore, many of the requested criteria for an AI/algorithm-based device cannot be fully answered or are not applicable to the information provided in this 510(k) summary. The document explicitly states: "No clinical or animal testing data is included in this submission."
However, I can extract information related to the device's characteristics and the non-clinical testing performed to support its substantial equivalence.
Here's an attempt to address your prompts based on the provided text, indicating where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria or reported performance in the typical format of an algorithm's diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating that the new device (airVata™) is "substantially equivalent" to a predicate device (EndSnorZ™ Sleep Appliance) based on its intended use, technological characteristics, and non-clinical performance testing.
The "acceptance criteria" here implicitly relate to demonstrating that the airVata™ device functions similarly and is as safe and effective as the predicate device.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance and Substantiation (as per 510(k)) |
|---|---|
| Indications for Use Equivalence: The device should have highly similar indications for use as the predicate device. | Achieved: "The airVata™ sleep appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The airVata™ sleep appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient." This is nearly identical to the predicate. |
| Technological Characteristics Equivalence: The device's technological characteristics (product code, device type, regulation, class, intended use, method of use/operation, biocompatibility, OTC/Rx, sterility, environment, and core design elements like rigid trays, material, mode of action) should be largely the same or highly similar to the predicate. Any differences must be mitigated through testing. | Achieved: Demonstrated through comparison table. Minor differences (e.g., product code, specific advancement mechanism, maximum adjustment/advancement) were identified. |
| Safety and Performance of Differences: Where technological differences exist (e.g., advancement mechanism, titration method, maximum adjustment/advancement), these differences must not raise new questions of safety or effectiveness and be mitigated by non-clinical testing. | Achieved: "Any differences in material composition and number of connector attachments for the Subject device and the impact on Subject device performance have been mitigated by means of clinical product validation performance testing." (Note: The document later clarifies "No clinical or animal testing data is included," implying "clinical" here refers to real-world context for mechanical/performance testing.) "Technological differences between the Subject and Predicate devices have been evaluated through validation performance testing of the Subject device. The results of the tests performed show that the Subject device is suitable for its intended use and confirms that the Subject device performs similarly to Predicate which has the same intended use." |
| Manufacturing Process Validation: The manufacturing process should be validated to ensure consistency. | Achieved: "Validation of the manufacturing process and compatible equipment was performed demonstrating consistency of the process output with that of the process input." |
| Physical Property Compliance: The device materials should meet relevant physical property standards. | Achieved: "Physical property testing according to ISO 20795-2, Dentistry - Base polymers - Part 2: Orthodontic base polymers was leveraged from the sponsor's material supplier." |
| Biocompatibility: Device materials must be biocompatible as per relevant standards. | Achieved: "Biocompatibility testing for the Subject device, was conducted in accordance with ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. ... Testing was performed according to ISO 10993-5 and ISO 10993-10." |
| MR Safety Assessment (if applicable): The device should be assessed for safety in an MR environment if intended for such use or if components might interact with MRI. | Achieved: "An MRI safety assessment was performed on the Subject device to support MR Safety labeling as required by the FDA guidance..." |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This 510(k) submission relies on non-clinical performance testing and comparison to a predicate device, not a clinical test set of patient data. The non-clinical tests would have their own sample sizes (e.g., number of material samples for physical property testing, number of devices for manufacturing validation), but these are not detailed in terms of patient data.
- Data Provenance: Not applicable for patient data. The non-clinical testing data would typically originate from the manufacturer's labs or contracted testing facilities. Given the US-based manufacturer and FDA submission, it's implied the testing would follow international standards recognized by the US, potentially performed in the US or by certified labs elsewhere.
- Retrospective or Prospective: Not applicable for patient data. The non-clinical tests would be prospective in nature, designed and executed for the premarket submission.
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 as this is not an AI/algorithm performance study requiring ground truth derived from expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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. The document explicitly states: "No clinical or animal testing data is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical appliance, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For a physical device, "ground truth" would relate to its physical properties, biocompatibility, and functional performance based on engineering specifications and intended use, rather than a diagnostic 'truth' established from patient data. The "truth" evaluated here is whether the device meets material, manufacturing, and safety standards to be considered equivalent to a legally marketed device.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires 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.”