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The ProSomnus® EVO™ [PH] Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Optionally, if the DentiTrac micro-recorder is completely embedded in the ProSomnus® EVO™ [PH] Sleep and Snore Device, the micro-recorder is intended to measure patient compliance therapy in combination with the DentiTrac System.

The ProSomnus® EVO™ [PH] Sleep and Snore Device consists of maxillary and mandibular device arches that when interfaced together reduce snoring and mild to moderate obstructive sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower device arches are connected with the herbst advancer. The device is designed and manufactured using Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) dental technologies, which allows the delivery of a well-fitting, aesthetic, and durable intraoral device for the patient. These devices are digitally milled to be patient-specific according to physician prescription. Prescribed advancements can be achieved by simply rotating the telescopic advancer hex nut or pinhole mechanism in an upward direction to increase the forward positioning of the mandible by smaller increments and according to the physician schedule. Advancements up to 12 mm past the initial bite position may be achieved with additional arches as prescribed by the physician The patient will be able to move the lower jaw forward, side-to-side, and open and close the mouth while wearing the device. The proposed device materials include medical grade polymer, stainless steel herbst arms, and biocompatible adhesive. The device is supplied nonsterile.

The provided text describes a 510(k) premarket notification for the ProSomnus® EVO™ [PH] Sleep and Snore Device. This device is an intraoral appliance intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults. An optional micro-recorder embedded in the device measures patient compliance.

The document does not describe acceptance criteria as typically found in a clinical study report (e.g., a specific sensitivity or specificity threshold). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through bench testing and a comparison of technological characteristics.

Here's a breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are not expressed as specific performance metrics (like sensitivity, specificity, or adverse event rates) against predetermined thresholds. Instead, the "acceptance criteria" are implied by the requirements to demonstrate substantial equivalence to predicate devices and adherence to relevant standards and guidance documents. The reported device performance is described through various bench tests and biocompatibility assessments, all of which "support the above indications for use as well as the claim of Substantial Equivalence."

The document states: "Product performance testing was performed to support the above indications for use as well as the claim of Substantial Equivalence." This indicates that the device met the requirements for these tests.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Bench testing was conducted on finished devices, unless otherwise specified." It does not provide specific sample sizes (N) for each individual bench test.

Regarding data provenance for a test set (implying patient data), this submission primarily relies on non-clinical performance data (bench testing) and comparison to predicate devices, rather than a clinical study with a test set of patient data. Therefore, information on country of origin or retrospective/prospective nature of a clinical test set is not applicable here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. Since the submission relies on bench testing and comparison to predicate devices, it does not involve the establishment of ground truth by human experts in the context of a diagnostic or clinical performance study. The "ground truth" for the engineering and biocompatibility tests would be established by validated testing methods and industry standards.

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of a human-reviewed test set or a clinical study that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or reported in this document. The device is a physical intraoral appliance, not an AI or diagnostic imaging device that would typically involve MRMC studies for comparative effectiveness with human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable. The device is a physical medical device, not an algorithm or AI system. The "performance" refers to its physical and biological characteristics, as well as its mechanical function, as demonstrated through bench testing.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Established engineering and materials standards (e.g., ASTM, ISO standards) for physical properties testing.
• Established biocompatibility guidelines (ISO 10993 series).
• The performance and established safety/effectiveness profiles of the predicate and reference devices (K182661 and K170692), which the subject device aims to be substantially equivalent to.

8. Sample Size for the Training Set

This is not applicable. The device is a physical appliance and does not involve AI/machine learning models that require training sets in the computational sense. The design and manufacturing are CAD/CAM based, but this refers to engineering design and fabrication, not AI model training.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8.

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The ProSomnus® EVO Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Optionally, if the DentiTrac micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device. the micro-recorder is intended to measure patient compliance therapy in combination with the DentiTrac System.

The ProSomnus® EVO Sleep and Snore Device is an oral device, which improves the flow of air through the patient's pharyngeal space during sleep by repositioning the mandible. The ProSomnus® EVO Sleep and Snore Device and the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate obstructive sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower device arches are CAD/CAM designed with twin-mated posts and are digitally milled to be patient-specific according to physician prescription. Customizable ergonomic features are available to improve patient comfort. Prescribed advancements can be achieved by simply removing the current upper or lower device arch and inserting the next upper or lower device arch in the mandibular advancement series. The device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps, or repositioning elastics. The device is supplied nonsterile.

A micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring. The micro-recorder is a compliance sensor, which logs the time the device is worn.

The provided text describes the acceptance criteria and performance data for the ProSomnus® EVO Sleep and Snore Device. This information is derived from a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance (bench testing) rather than clinical studies involving human patients or AI performance.

Therefore, many of the requested details regarding clinical study design (sample size of test/training sets, data provenance, expert adjudication, MRMC studies, ground truth establishment) are not applicable (N/A) because this submission relies on bench testing to demonstrate performance and substantial equivalence.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in terms of a "test set" as this was bench testing on physical devices, not a dataset for an algorithm. The reported numbers (e.g., 235.4 lbf for AP Shear Strength) are likely averages or representative values from multiple tests, but the exact number of units tested is not stated.
• Data Provenance: This refers to non-clinical bench testing. There is no information about country of origin, or whether it was retrospective or prospective, as these terms usually apply to clinical data.

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

• N/A: Ground truth based on expert consensus is not relevant for this type of bench testing. The "ground truth" for the performance specifications is determined by the physical properties and engineering measurements of the device as tested in a laboratory setting. No human experts are used for this type of "ground truth" establishment in this context.

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

• N/A: No adjudication method specified or implied as this was bench testing on device performance, not interpretation of data by multiple readers.

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

• N/A: No MRMC study was conducted. This device is a physical intraoral device, not an AI-powered diagnostic or assistive tool.

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

• N/A: No standalone algorithm performance was assessed as this is a physical medical device, not an algorithm.

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

• Bench Testing/Engineering Specifications: The "ground truth" for the device's performance relies on objective measurements from mechanical testing (e.g., force, torque, length, durability) against pre-defined engineering specifications and comparison to the predicate device's measured performance.

8. The sample size for the training set

• N/A: There is no "training set" as this device is not an AI/machine learning model.

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

• N/A: Not applicable since there is no AI training set.

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