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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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