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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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Oravan Herbst is intended to reduce snoring and mild to moderate sleep apnea in adults.

The Oravan Herbst is intended to reduce snoring and mild to moderate sleep apnea in adults. It is made of orthodontic acrylic trays and herbst assembly. It has two acrylic pieces - the upper acrylic tray that fits over the top posterior teeth and the lower acrylic tray that fits over the bottom posterior teeth. The herbst assembly provides a standard titration mechanism and enables mandibular advancement. With this design, the Oravan Herbst allows the physician to increase the patient's pharyngeal opening, improving their ability to exchange air during sleep and reduce vibrations. Each Oravan Herbst device is patient-specific (customized for each patient).

The device in question is the Oravan Herbst, an intraoral device intended to reduce snoring and mild to moderate sleep apnea in adults.

Here's an analysis based on the provided text, addressing the points requested:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present specific acceptance criteria in terms of clinical performance metrics (e.g., AHI reduction, success rate) or a "reported device performance" in a clinical context. Instead, the substantial equivalence relies on:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission states, "The submission does not rely on any clinical data; therefore no clinical testing was performed." This means there was no test set of patient data used to evaluate the device clinically. The evaluation was based on non-clinical data and comparison to predicate devices.

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)

Since no clinical data or clinical testing was performed, there was no test set requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set was used.

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 an intraoral appliance, not an AI-powered diagnostic tool, and no MRMC study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical studies were performed. The "ground truth" for substantial equivalence was primarily based on established standards (e.g., ISO for materials) and the characteristics of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

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The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.

The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is a removable intraoral device used for treating night time snoring and mild to moderate obstructive sleep apnea. It consists of two customized fabricated chrome cobalt (Vitallium 2) frameworks that conform to the patient's dentition in the upper and lower jaws and are connected bilaterally via a stainless steel telescoping Herbst device. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to improve the patient's ability to breathe during sleep without obstruction of the pharyngeal airway. The device is customized according to the prescription of the prescribing dentist for each patient. It has an adjustment mechanism enabling the amount of mandibular advancement to be set or altered by the dentist. The maximum protrusion and allowable increments of adjustment are 5mm.

The provided text describes the Somnowell Mandibular Advancement Appliance (Somnowell MAA) and its submission for FDA clearance. The document focuses on demonstrating substantial equivalence to a predicate device, TheraSom-CAST (K113516), rather than on presenting a study with specific acceptance criteria and performance metrics for the Somnowell MAA itself.

Therefore, many of the requested details about a study proving the device meets acceptance criteria, such as clinical performance, sample sizes, expert ground truth, adjudication methods, and MRMC studies, are not available in this document. The submission explicitly states "Clinical testing - No clinical data is included in this submission."

However, I can extract information regarding non-clinical testing (bench testing) and the general claims of substantial equivalence based on technological characteristics and performance compared to the predicate.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no specific quantitative acceptance criteria or clinical performance metrics for the Somnowell MAA are provided, I'll list the general performance claims and the results of the bench testing. The "acceptance criteria" here are implicitly linked to demonstrating equivalence to the predicate's performance in mechanical tests.

2. Sample size used for the test set and the data provenance:

• Sample Size (Bench Testing): Not specified.
• Data Provenance: Not specified, but generally refers to laboratory bench testing conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this was bench testing, not a clinical study requiring expert diagnosis or ground truth establishment in that context.

4. Adjudication method for the test set:

• Not applicable for bench testing.

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 MRMC clinical study was conducted. The submission explicitly states "Clinical testing - No clinical data is included in this submission." This device is a physical appliance, not an AI or imaging diagnostic tool, so an MRMC study is not relevant to its type of evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This is not an algorithm or AI device. Standalone performance as commonly understood in AI/software evaluation is not applicable.

7. The type of ground truth used:

• For the bench tests, the "ground truth" would be the engineering specifications and expected mechanical properties, tested against established laboratory methods. For biocompatibility, it's compliance with ISO 10993-5 (absence of cytotoxicity).

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set for this type of device.

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The SomnoDent Fusion is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The SomnoDent Fusion is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is patient specific (it is customized for each patient) and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent Fusion is a modification to the SomnoDent Classic (K050592), SomnoDent Flex (K073004), SomnoDent G2 (K121340) and SomnoDent Herbst (K130558). The SomnoDent Fusion is identical to SomnoDent Classic, SomnoDent Flex, SomnoDent G2, and SomnoDent Herbst except for differences in the adjustment mechanism. Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

Here's the analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: SomnoDent Fusion (an intraoral device for snoring and mild to moderate obstructive sleep apnea)

1. A table of acceptance criteria and the reported device performance

Based on the provided document, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through mechanical testing. The performance is reported as meeting this equivalence.

2. Sample size used for the test set and the data provenance

The document states: "Mechanical testing was conducted on the calibration mechanism of the subject device." However, it does not specify the sample size for this mechanical testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) of this testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document as the study described is mechanical testing, not a clinical study involving human assessment or ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable as the described study is mechanical testing, not a clinical study involving human judgment or adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. The SomnoDent Fusion is a physical intraoral device, not an AI or imaging diagnostic tool that would be evaluated with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance test in the context of an algorithm or AI was not performed, nor is it applicable to this device. The device is a physical intraoral appliance. The "standalone" performance described is the mechanical testing of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks established based on the predicate devices. The document implies that the "truth" is the "applicable pressures" and successful functioning compared to the predicate.

8. The sample size for the training set

This information is not applicable as the described study is mechanical testing for substantial equivalence, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for a machine learning model.

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