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510(k) Data Aggregation
(80 days)
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
| Performance Specification | ProSomnus® EVO Sleep and Snore Device (Subject Device) | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|
| Anterior-Posterior (AP) Shear Strength (lbf) | 235.4 | Must be greater than 200 lbf | Pass |
| Stroke (in) | 0.17 | Must be greater than 0.1 | Pass |
| Anterior-Posterior Directional Torque (lbf-in) | $235.4 \text{ lbf } * 0.17 \text{ in } = 40.0 \text{ lbf-in}$ | Must be equal or better than predicate device | Pass |
| Lateral Direction Shear Strength (lbf) | 71.5 | Must be greater than 50 lbf | Pass |
| Stroke (in) | 0.17 | Must be greater than 0.1 | Pass |
| Lateral Directional Torque (lbf-in) | $71.5 \text{ lbf } * 0.17 \text{ in } = 12.2 \text{ lbf-in}$ | Must be equal or better than predicate device | Pass |
| Durability when elastic bands pull on hooks at peak force (mm & lbs.) | 135.55 mm stretch length with an average peak force of 5.06 lbs. With no visible damage to the device and its metal-free hooks. | Must be equal or more durable than predicate device | Pass |
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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