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The Sapphire Dorsal Comfort Fit Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.

The Sapphire Dorsal Comfort Fit Appliance is an intraoral device used for reducing snoring and mild to moderate obstructive sleep apnea. It consists of fitted trays which fit over the upper and lower teeth. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is made for each patient and has an expansion screw adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

The provided text describes a 510(k) premarket notification for the Sapphire Dorsal Comfort Fit Appliance. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study to establish new performance criteria. Therefore, the information requested regarding acceptance criteria, specific study designs, sample sizes for test/training sets, expert qualifications, and adjudication methods for evaluating an AI-powered device is largely not applicable in this context.

Here's an breakdown based on the information available:

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

This document does not establish new acceptance criteria as it's a 510(k) submission seeking substantial equivalence. The "performance" is demonstrated through non-clinical testing and comparison to predicate devices, showing that the new device is as safe and effective as existing ones.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. No clinical test set involving human patients was used for performance evaluation in the context of an "AI software" or "diagnostic" device. The testing described is for material properties and device integrity.
• Data Provenance: Not applicable. The testing was conducted on material samples and a prototype device "assembly."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No expert review for ground truth was established as this is not an AI/diagnostic device.

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. This is not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical device (intraoral appliance), not an algorithm or software.

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

Not applicable. The "ground truth" for this device's safety and effectiveness is established by demonstrating its material properties, design features, and intended use are substantially equivalent to already cleared predicate devices.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

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The Crane Acrylic Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.

The Crane Acrylic Herbst Appliance is comprised of upper and lower patient-specific acrylic splints connected bilaterally via a telescoping Herbst mechanism that orients the jaw in a predetermined relationship. The Herbst mechanism allows the patient vertical and lateral range of movement while the jaws are oriented in the biting relationship determined by the positioning of the mechanism as it connects to the respective arch splint. The Appliance positions the lower jaw forward and open vertically from its normal location which causes a protrusion in the mandible in relation to the maxilla. The appliance aims through this repositioning (which is temporary while the appliance is being used) to increase air exchange, and to reduce snoring and apnea by increasing pharyngeal space.

The prescribing dentist determines the repositioning of the mandible through a patient-specific protrusive bite registration taken by the dentist is also able to adjust the mandible's position by altering the Herbst mechanism, and/or adjusting the acrylic portion of the device. The Acrylic Splint Herbst Appliance is removable by the patient, and is worn while sleeping to support the mandible in a forward position determined by the prescribing dentist.

This document is a 510(k) premarket notification for the Crane Acrylic Herbst Appliance, an intraoral device intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea. The submission claims substantial equivalence to a predicate device, the Respire Medical LLC - Respire Pink Series (K131138), based on similar intended use and technological characteristics.

Here’s a breakdown of the information requested, based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or report performance metrics (e.g., specific reductions in snoring or AHI). Instead, it focuses on demonstrating substantial equivalence to a predicate device, arguing that the new device has the same intended use and technological characteristics and does not raise new safety or effectiveness concerns.

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 does not describe a specific clinical study or test set with a listed sample size, data provenance, or study design (retrospective/prospective). This 510(k) submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data from a dedicated study.

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. As no specific clinical test set is described, there's no mention of experts establishing ground truth. The submission's argument is theoretical equivalence based on design and materials, not empirical clinical performance data.

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

Not applicable. 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 applicable. The device is a physical intraoral appliance, not an AI software or a device that requires "readers" for interpretation. Therefore, a MRMC study is irrelevant.

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

Not applicable. The device is a physical appliance and does not involve an algorithm.

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

Not applicable. No clinical study for the new device is presented that would require establishing ground truth from patient data. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device (Respire Medical LLC - Respire Pink Series, K131138), to which the Crane Acrylic Herbst Appliance is deemed substantially equivalent.

8. The sample size for the training set

Not applicable. No clinical study with a training set is described for this 510(k) submission.

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

Not applicable. No clinical study with a training set is described for this 510(k) submission.

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