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The DNA Appliance is intended to reduce snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.

The DNA appliance is an intraoral device to reduce snoring, and/or mild to moderate sleep apnea in adults 18 years of age and older. It consists of either an upper tray, or both, and is designed to open the airway during sleep. The device is customized to each patient, and features an adjustment mechanism to allow it to be further customized to each patient.

The device is identical to the already-marketed mRNA appliance except the top and bottom trays do not interlock to advance the jaw.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it detail a study proving that the device meets such criteria. The document is a 510(k) premarket notification for the DNA Appliance, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (mRNA appliance) rather than presenting performance data against defined acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The document primarily focuses on:

• Device Description: The DNA Appliance's components, mechanism of action, and customization.
• Intended Use: Reducing snoring and/or mild to moderate obstructive sleep apnea in adults 18 years and older.
• Comparison to Predicate Device: Highlighting similarities in mechanism, design (except for mandibular advancement), materials, cleaning instructions, and labeling with the mRNA appliance.
• Testing: Mentioning a risk analysis and reliance on peer-reviewed literature and Real-World Data (RWD) to demonstrate the DNA Appliance's ability to reduce snoring and sleep apnea, asserting no new safety and efficacy questions compared to the predicate device.

To answer your specific questions, I would need a different type of document, such as a clinical study report or a detailed device performance evaluation.

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To reduce nighttime snoring and mild to moderate sleep apnea in adults.

The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient and features an adjustment mechanism (expansion screw) to allow it to be further customized to each patient.

The device is identical to the already-marketed mRNA appliance except the top and bottom trays interlock using the Herbst telescoping hinge instead of the mRNA flange. It is used in the predicate SomnoMed® device as well as many other devices in the market, e.g. Oasys Sleep (K181571) reference and Oasys Oral/Nasal Airway system (K030440). The mechanism of action is mandibular advancement, the same mechanism of action is used in the primary predicate device.

The provided document is a 510(k) summary for the mmRNA appliance, which is an intraoral device for snoring and mild to moderate sleep apnea. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Vivos Therapeutics mRNA Device, K130067).

However, the document does not contain a study that proves the device meets specific acceptance criteria. Instead, it relies on the argument of substantial equivalence to a predicate device, as permitted under the 510(k) pathway. This means that direct performance data from a clinical study for the subject device (mmRNA appliance) is generally not required if it can be demonstrated that the new device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested details about acceptance criteria, clinical study results, expert involvement, and ground truth establishment are not available in this document for the subject device. The document focuses on demonstrating similarity to the predicate device.

Below is an attempt to address your request based on the information available in the document, highlighting what is not present.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence and General Claims)

As this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device that is already deemed safe and effective for the indicated use. The document does not provide specific quantitative acceptance criteria or a study with direct performance metrics for the mmRNA appliance itself. Instead, it makes claims about its function and similarity to the predicate.

Missing Information (Not provided in the document):

The following information is not available in the provided 510(k) summary because the document focuses on substantial equivalence rather than presenting a new clinical study for the subject device:

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 for the subject device as no new clinical study data is presented for its performance. The document relies on the established performance of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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: Not applicable, as this is a medical device, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no new performance study is presented. The "ground truth" for the predicate device's efficacy would have been established through its own clinical trials or prior regulatory clearances. The current document asserts the subject device functions similarly.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is available regarding "the study that proves the device meets the acceptance criteria":

The document argues for substantial equivalence to the predicate device (Vivos Therapeutics mRNA Device, K130067), rather than presenting a new clinical study. The "proof" is based on:

1. Similarity in Intended Use: Identical indications for use as the predicate device.
2. Similarity in Mechanism of Action: Mandibular advancement, the same as the primary predicate device. The only difference is the specific hinge mechanism (Herbst hinge vs. flange).
3. Similarity in Design and Materials: Customized acrylic trays with an expansion screw, optional extender, and standard dental materials (acrylic, stainless steel orthodontic wires).
4. Reliance on Predicate Testing: Biocompatibility is assumed due to identical materials. Mechanical testing for the Herbst hinge is referenced from another predicate (SomnoMed® SomnoDent Herbst, K130558). A risk analysis concluded equivalence to predicates.

In conclusion, the document is a 510(k) submission that seeks clearance based on substantial equivalence to a predicate device, not on new clinical study data for the subject device itself. Therefore, detailed information about acceptance criteria met by a specific study is not provided for the mmRNA appliance but rather implied through its similarity to already cleared devices.

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