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The Meridian PM is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Meridian PM is a single device consisting of two parts and upper appliance and lower appliance it is collectively known as the Meridian PM : The Meridian PM treats snoring and Obstructive Sleep Apnea (OSA).

The Meridian PM device is used in a patient treatment model for specific diagnosis of simple snoring, and/or Obstructive Sleep Apnea (OSA).

The upper and lower appliances help to reposition the lower jaw such that it is moved to a forward position during sleep.

The Meridian PM system is used for treating snoring and obstructive sleep apnea and consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable vertical wings, or by the industry standard "Herbst mechanism" which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These device(s) function as a mandibular repositioning or mandibular advancment device (MAD) as Meridian PM acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep, decreasing symptoms of OSA. The devices will be custom made for each patient and allow the dentist or physician to control the degree of mandibular advancement at the time of device(s) will be sold by prescription only.

The provided text describes the submission for K170053, a 510(k) premarket notification for the Meridian PM device, an intraoral device intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The submission focuses heavily on demonstrating substantial equivalence to predicate devices (SICAT OptiSleep and TheraSom-CAST) rather than presenting a standalone study of the device's clinical performance against specific acceptance criteria for efficacy in reducing snoring or OSA.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical efficacy is not present in the provided document. The performance data presented is entirely non-clinical and relates to the device's material properties and biocompatibility.

Here's a breakdown of the available information:

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

• Clinical Performance/Efficacy: The document does not provide specific acceptance criteria or reported performance for clinical outcomes such as reduction in AHI (Apnea-Hypopnea Index) or snoring intensity. The "acceptance criteria" discussed are for non-clinical tests.

• Non-Clinical Performance:

  Test Category	Test Method	Acceptance Criteria	Reported Performance
  Material Properties		"internal requirements, applied national standards, and applied international standards"	Passed
  Flexural Properties	ISO 178:2010/Amd.1:2013(E) Method A	(Not specified directly, but implied by "passed")	Passed
  Plane-Strain Fracture Toughness	ASTM D5045 -14 (modified notch geometry)	(Not specified directly, but implied by "passed")	Passed
  Tensile Properties	ASTM D638-14 - Modified specimen length, test speed and grip separation	(Not specified directly, but implied by "passed")	Passed
  Biocompatibility	ISO 10993-1:2009 and FDA guidance document	(Not specified directly, but implied by "passed")	Passed
  Cytotoxicity	ISO 10993-5	(Not specified directly, but implied by "passed")	Passed
  Irritation and Skin Sensitization	ISO 10993-10	(Not specified directly, but implied by "passed")	Passed
  Chemical Characterization	ISO 10993-18	(Not specified directly, but implied by "passed")	Passed
  Risk Analysis	ISO 14971	"outcomes of these risks are considered acceptable...all potential risks have been mitigated"	Passed

Regarding the clinical study details, the document does not contain the requested information:

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

• Not Provided. There is no mention of a human test set for clinical efficacy.

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)

• Not Provided. Not applicable as no clinical test set is described.

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

• Not Provided. Not applicable as no clinical test set is 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

• Not Provided. This is not relevant for this type of device (intraoral snore/OSA device) and no MRMC study or AI component is mentioned.

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

• Not Provided. This is not relevant for this type of device and no algorithm is mentioned for performance assessment.

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

• Not Provided. Not applicable as no clinical ground truth is described. The "ground truth" for the non-clinical tests would be the established chemical, physical, and biological properties as per the standards.

8. The sample size for the training set

• Not Provided. Not applicable as no clinical training set or machine learning model is described.

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

• Not Provided. Not applicable as no clinical training set is described.

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