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The EMA 3D is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The EMA 3D device is a simple hardware device. It is an oral appliance and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients. The EMA 3D device is intra-oral device used for treating snoring and mild to moderate Obstructive Sleep Apnea (OSA). It has a patented button hook design with variable elastic band for optimum titration with bitewing if needed. The device consists of two custom fitted trays which fit over the upper and lower dentition of a patient. The trays are standard biocompatible trays that do not reposition teeth. Each tray holds the teeth in their present location not allowing tooth movement. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air. There are four button hooks utilized on the EMA 3D device (two hooks per tray, two trays top and bottom. The hooks must be placed at a distance of 21mm apart from the top tray hook to the bottom tray hook center to center. Though there is no requirement except the opitimum location for hook placement between the top and bottom trays is on the upper bicuspid and the lower first molar. Button hooks and bite blocks for the EMA 3D utilize standard dimensions. These button hooks serve as fastening anchors for Elastic Straps that come in four different color coded strengths: White-Soft, Yellow-Medium, Blue-Firm and Clear- Extra Firm. These straps also come in 9 different lengths such that the Dental Professional can ensure the patient specific correct amount of mandibular advancement the lengths are as follows: 21mm, 20mm, 19mm, 18mm, 17mm, 16mm, 15mm, 14mm, 13mm.

Based on the provided text, the device in question is the EMA 3D, an intraoral device for snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The substance of the application is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical efficacy through a comparative effectiveness study or standalone algorithm performance. Therefore, the information provided focuses on non-clinical performance data and comparison to predicates rather than a clinical study with human readers or AI.

Here's a breakdown of the requested information based on the document:

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

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds for "Pass" or "Fail" for all tests. Instead, it states that "All testing was considered successful and met identified acceptance criteria" and "The EMA 3D passed all the testing in accordance with internal requirements, applied national standards, and applied international standards." The performance data is primarily qualitative and comparative to predicate devices concerning materials, design, and functionality.

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

The document refers to "testing" of the device components and materials. It does not specify sample sizes for these tests in terms of number of devices or patients. The data provenance is also not explicitly stated in terms of country of origin or retrospective/prospective nature. The tests mentioned are laboratory-based material and component performance tests, not clinical studies on patient populations.

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)

This information is not applicable and not provided. The "ground truth" concept usually applies to clinical efficacy or diagnostic accuracy studies (e.g., for AI/image analysis devices). For a hardware device seeking 510(k) clearance based on substantial equivalence, the "ground truth" refers to the adherence to engineering standards and biocompatibility requirements rather than clinical consensus.

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

This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which is not the primary focus of this 510(k) submission as 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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance. This device is a physical intraoral appliance, not an AI or imaging device where such a study would be relevant.

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

There is no mention of a standalone algorithm performance. This is a physical medical device.

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

For this device, the "ground truth" is established through adherence to recognized material and performance standards (e.g., ISO, ASTM for mechanical properties; ISO 10993 for biocompatibility) and demonstrable equivalence to predicate devices in terms of indications for use, technological characteristics, and safety profiles. It is not based on direct clinical outcomes data from new patient studies for this 510(k) submission.

8. The sample size for the training set

This information is not applicable and not provided. This is not a machine learning or AI device that would require a "training set."

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

This information is not applicable and not provided. There is no training set for this type of device.

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