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The C.A.R.E. Appliances are intended to reduce nighttime snoring and to treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older. The C.A.R.E. Appliances are also intended to treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed.

The C.A.R.E. appliances are intended to reduce nighttime snoring and to treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older. The C.A.R.E. appliances are also intended to treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed. They consist of an upper tray and a lower tray 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 DNA appliance does not connect the upper and lower trays, while the mRNA and mmRNA appliances connect the trays with a flange and hinge respectively.

The devices are identical to the already-marketed predicates of the same name.

This document is a 510(k) summary, which is a premarket notification for a medical device to demonstrate that the device is at least as safe and effective as a legally marketed device (predicate device). It does not contain information about the acceptance criteria of a specific study nor does it describe a study that proves the device meets the acceptance criteria. Instead, it outlines the device's indications for use and provides real-world clinical data and a peer-reviewed study to support an expanded indication for use by demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested items, such as acceptance criteria for device performance, details of a specific test set, ground truth experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not explicitly present as this document serves a different regulatory purpose.

However, based on the provided text, I can extract and infer some relevant information:

Key Takeaway: This document is not a report of a study designed to establish acceptance criteria or prove a device meets them in the manner typically seen for AI/ML device clearances. It is a 510(k) summary for a physical medical device (oral appliance) seeking an expanded indication for use, primarily relying on clinical data and substantial equivalence to previously cleared devices. The "performance" is demonstrated through real-world clinical outcomes and a comparative study, rather than specific acceptance criteria for an AI algorithm's output.

Here's an attempt to answer the questions based on the provided text, noting where information is not available:

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

The document does not specify "acceptance criteria" in a quantitative, pre-defined manner for the device's efficacy. Instead, it presents observed performance from clinical data and a study, which implicitly served to demonstrate sufficient efficacy for an expanded indication.

Implicit "Performance Metrics" from Studies:

• AHI Post-Treatment: 21.7 ± 14.8
• AHI Change: -24.3 ± 18.1
• Percent Decrease: 50.8% | Demonstrates significant reduction in AHI. |
  | Patients Improved by at least 1 Classification (Severe OSA) | 78% (57/73 patients) | High percentage of patients show clinical improvement. |
  | Patients Improved by 45% or 1 classification (Severe OSA) | 80% (58/73 patients) | High percentage of patients show clinical improvement. |
  | Patients Resolved (Severe OSA) | 14% (10/73 patients) | Some patients achieve full resolution. |
  | AHI Reduction (Moderate OSA) | - AHI Pre-Treatment: 21.6 ± 4.5
• AHI Post-Treatment: 12.0 ± 10.5
• AHI Change: -9.5 ± 10.8
• Percent Decrease: 44.4% | Demonstrates significant reduction in AHI. |
  | Patients Improved by at least 1 Classification (Moderate OSA) | 80% (28/35 patients) | High percentage of patients show clinical improvement. |
  | Patients Improved by 45% or 1 Classification (Moderate OSA) | 80% (28/35 patients) | High percentage of patients show clinical improvement. |
  | Patients Resolved (Moderate OSA) | 20% (7/35 patients) | Some patients achieve full resolution. |
  | Transpalatal Width Same or Improved (Severe OSA) | 99% (72/73 patients) | Demonstrates positive or stable anatomical change. |
  | Transpalatal Width Same or Improved (Moderate OSA) | 100% (35/35 patients) | Demonstrates positive or stable anatomical change. |
  | AHI Same or Improved (Severe OSA) | 97% (71/73 patients) | Very high consistency in AHI not worsening, often improving. |
  | AHI Same or Improved (Moderate OSA) | 91% (32/35 patients) | Very high consistency in AHI not worsening, often improving. |
  | Safety | 10% of patients had inadvertent tooth movement and/or changes in bite that were treated with braces or aligners. | No persistent safety issues, manageable side effects. |

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

• Real-World Clinical Data (RWD):
  • Sample Size:
    • Severe OSA: 73 patients
    • Moderate OSA: 35 patients
    • Total RWD patients: 108 patients
  • Data Provenance: Obtained from a research database.
    • Country of Origin: Not specified.
    • Retrospective/Prospective: "Real Word Clinical Data obtained from a research database over a period of 5 years (2018-2023)" implies a retrospective analysis of existing data.
• Peer-Reviewed Study:
  • Sample Size: 15 consecutive patients.
  • Data Provenance: Not specified for country of origin or retrospective/prospective outside of being a "blinded, controlled, randomized study."

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. The "ground truth" here is the clinical diagnosis of OSA and AHI values from pre- and post-treatment sleep studies, not expert annotations of images for an AI algorithm.

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

This information is not provided as this is not an AI/ML clinical study requiring adjudication of interpretations. The "ground truth" is measured AHI from sleep studies.

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

There was no MRMC comparative effectiveness study done with AI assistance described. This device is an oral appliance, not an AI software. The provided peer-reviewed study compared two types of C.A.R.E. appliances (DNA vs mRNA) to each other regarding AHI reduction.

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

This question is not applicable as the device is a physical oral appliance, not an AI algorithm.

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

The ground truth used for assessing the device's effectiveness was clinical outcomes data, specifically:

• Apnea-Hypopnea Index (AHI) values derived from pre- and post-treatment sleep studies.
• Transpalatal Width changes.
• Patient Classification improvements (e.g., severe to moderate OSA).
• Resolution of OSA.

8. The sample size for the training set

This question is not applicable. This document describes a physical medical device (oral appliance) for which there is no "training set" in the context of machine learning. The "training" for the device's design comes from medical and engineering principles, and its efficacy is evaluated through clinical studies/data, not through training a model.

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

This question is not applicable as there is no training set for an AI algorithm in this context.

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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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