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The NightBlocks™ Appliance is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The NightBlocks™ Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

The NightBlocks™ appliance consist of two removable, custom fabricated acrylic trays that fit separately over the upper and lower dental arches and engage each other in order to reposition the mandible in a slightly anterior position. They contain stainlesssteel ball clasps for extra retention and stainless-steel orthodontic expansion screws on the buccal portion of the upper tray that engage with the dorsal wings of the lower tray. The trays occlude on the left or right molar and premolar region. Every device is custom prescribed and fabricated for each patient from dental models and is adjustable at the time of delivery and anytime thereafter as it is intended to be used in the home setting.

The principal of operation is jaw repositioning. Worn during sleep, the NightBlocks™ function as a mandibular advancement device which acts to increase the patient's pharyngeal airway space, improving their ability to exchange air during sleep. The anterior repositioning of the mandible prevents the tongue from sliding backward or downward for a prone sleeping individual. Therefore, the airway will be larger, contributing to the reduction in snoring and mild to moderate sleep apnea.

Materials: Polymethylmethacrylate Polymer and Monomer (Lang Orthodontic Acrylic K141439), medical grade stainless steel wire (AJ Wilcock), and orthodontic stainlesssteel expansion screws (Leone).

This document is a 510(k) summary for "The NightBlocks™ Appliance." It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested details, such as a table of acceptance criteria and reported performance, sample sizes for test sets, expert involvement in ground truth, MRMC studies, or standalone algorithm performance, are not applicable as this submission relies on demonstrating similarity to an already cleared device, not on new clinical performance data.

Here's an analysis of the provided information in the context of your questions:

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

• Not Applicable. This submission is for substantial equivalence. It does not define new clinical performance acceptance criteria or report new clinical device performance data. The device's performance is inferred to be equivalent to the predicate device.

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

• Not Applicable. No clinical test set data was used. The submission states, "Clinical testing has not been performed."

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 Applicable. No clinical test set requiring ground truth establishment was conducted.

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

• Not Applicable. No clinical test set requiring adjudication was conducted.

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 a physical intraoral appliance, not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are irrelevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. No new clinical ground truth was established as no new clinical testing was performed.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not Applicable. As above, this is a physical medical device.

Summary of the document's approach:

The manufacturer, Advanced Facialdontics LLC, is seeking 510(k) clearance for "The NightBlocks™ Appliance." Their strategy is to demonstrate substantial equivalence to existing legally marketed predicate devices, primarily the "ATG/SM-OSA Appliances (K130130)."

The core argument for equivalence is based on the following:

• Identical Indications for Use: Both the proposed device and the predicate are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults, by supporting the lower jaw in a forward position.
• Similar Technological Characteristics:
  • Principle of operation (mandibular repositioning)
  • Prescription device, custom fabricated, intraoral, removable by patient, reusable.
  • Environment of use (home).
  • Non-sterile.
  • Nearly identical raw materials (Polymethylmethacrylate Polymer and Monomer, medical grade stainless steel wire, orthodontic expansion screws).
  • Manufacturing, finishing, and cleaning processes are identical and performed at the same facility (Space Maintainers Laboratory).
• Minor Design Differences: The only noted differences are the location of the occluding surface of the upper and lower trays and the inclusion of additional braided stainless-steel supporting wire within the dorsal wings of the proposed device. The submission states these minor differences "do not affect the substantial equivalence" as they don't change the indication, principle of operation, manufacturing/sterilization process, or elevate risk.
• Non-Clinical Tests: A risk analysis per ISO 14971 was performed, comparing potential risks (soreness, obstruction, tooth movement, TMD, saliva, breakage) to the predicate device, concluding risks were equivalent or less. Biocompatibility and physical properties were leveraged from the predicate device materials.
• Clinical Tests: Explicitly stated that "Clinical testing has not been performed."

In essence, the "study" proving the device meets criteria (or rather, is substantially equivalent) is a comparison and analysis of the device's design, materials, manufacturing, and intended use against a legally marketed predicate device, rather than a novel clinical effectiveness trial. The acceptance criteria are implicitly met if the device is deemed sufficiently similar to a device already cleared by the FDA for the same indications for use.

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