(147 days)
The MICRODENTAL, Inc. Micr02 device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Optionally, if the DentiTrac® micro-recorder is completely embedded in the MicrO2 device, the microrecorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System
The MicrO2 OSA device series consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower arch devices are designed with twin-mated posts and are CAD/CAM generated specifically for each prescription. Designed as a patient-specific device, the MicrO2 series consists of one or multiple lower device(s) together with one or multiple mated-post upper device(s) that are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing the current upper or lower device and inserting the next upper or lower device in the mandibular advancing series. The MicrO2 does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps or repositioning elastics. The MicrO2's twin-mated post and lingualess design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear.
The Micr02 OSA device with Micro-recorder is identical to the primary predicate device, Somnomed with Micro-Recorder except for the difference in the adjustment mechanism. The MicrO2 uses twin mated posts to adjust whereas the Somnomed uses embedded screws. Without the compliance chip the subject device is identical in materials and manufacturing to the reference predicate MicrO2 OSA device. Any differences introduced by these modifications when compared to the predicate device, do not introduce any new concerns.
This submission adds the option for any clinician to decide to incorporate a DentiTrac® Microrecorder compliance chip embedded into a MicrO2 OSA device to record a patient's compliance to the prescribed oral appliance therapy. The MicrO2 OSA device with Micro-recorder is to be used in combination with the DentTrac® System which includes a base station at the provider's office used to upload the data from the chip to a web application for cloud based reporting and tracking. During scheduled visits, the data within the DentiTrac® can be uploaded to a web application for cloud-based reporting and tracking using a DentiTrac® Base Station at the clinician's office. The DentiTrac® micro-recorder monitors the wear time through the oral temperature, as well as tracks movements and head position. This is the identical chip that is included in the predicate device – the Somnodent with Micro-Recorder. The inclusion of the embedded DentiTrac® micro-recorder, provides additional information when used in combination with the DentiTrac® System, but does not impact the operating principles of the Micr02 OSA device as established by the reference device, the MicrO2 OSA without the DentiTrac® Micro-recorder.
This FDA 510(k) summary describes the MicrO2 OSA Device with Micro-recorder. However, it explicitly states, "Clinical testing was not conducted on the subject device." Instead, the submission relies on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, and non-clinical performance testing. Therefore, the information requested in the prompt related to acceptance criteria for clinical performance, sample sizes for test sets, ground truth establishment, expert adjudication, or MRMC studies for an AI device is not applicable to this submission.
The document focuses on the mechanical performance and biocompatibility of the device and the embedded micro-recorder, not on the clinical efficacy of an AI-driven component.
Here's a breakdown of the available information, addressing the prompt as best as possible given the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the traditional sense of numerical clinical performance targets for an AI device. Instead, it relies on demonstrating substantial equivalence to predicate devices through various comparisons and non-clinical testing. The "performance" reported is primarily in terms of meeting manufacturing specifications and maintaining structural integrity and biocompatibility.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Manufacturing Quality Control | MicroDental Laboratories performs 100% visual and functional inspection to ensure the device meets manufacturing specifications for the MicrO2 OSA device with the inclusion of the DentiTrac® MicroRecorder Compliance Chip. |
| Biocompatibility | Biocompatibility assessment in accordance with ISO 10993-1 was conducted for the reference predicate (MicrO2 OSA device) and is considered supportive of the subject device as no new materials were added. Monomer leachability testing performed. |
| Structural Integrity / Mechanical Performance | Compression and shear testing to approximate mechanical force applied during use was performed on the reference predicate. This testing is still applicable as the addition of the DentiTrac® Micro-Recorder does not impact structural integrity. |
| DentiTrac® Micro-recorder Functionality | The device can be repeatedly, and reliably embedded with the DentiTrac® and retain the same Quality Control functionality of the MicrO2 and DentiTrac®. The micro-recorder is completely sealed under a layer of PMMA. |
| Mode of Action (Mandibular Repositioning) | Identical intended use and mode of action (mandibular repositioning to increase pharyngeal space) as predicate devices. |
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. No clinical test set data is described for the subject device. Non-clinical testing refers to lab-based assessments of materials and mechanical properties.
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 expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set with adjudication is described.
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 device is not an AI algorithm and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests described, the "ground truth" would be established engineering specifications, material standards, and validated testing methods.
8. The sample size for the training set
Not applicable. The device is not an AI algorithm and does not have a training set.
9. How the ground truth for the training set was established
Not applicable. The device is not an AI algorithm and does not have a training set.
§ 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.”