(99 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Properties: | All tests met requirements, implicitly demonstrating equivalence or suitability for intended use. |
| - Metal-Free Button Hook Strength | Tested |
| - Shear Testing | Tested |
| - Loctite 3922 Cure Time Test | Tested |
| - Polymer Adhesive Pull Test | Tested |
| - Modulus of elasticity (tensile) | Tested |
| - Tensile strength at yield | Tested |
| - Elongation at break | Tested |
| - Flexural strength | Tested |
| - Modulus of elasticity (flexural) | Tested |
| - Compression strength | Tested |
| - Compression modulus | Tested |
| - Notched impact strength (Izod) | Tested |
| - Rockwell hardness | Tested |
| - Deflection temperature | Tested |
| - Moisture absorption | Tested |
| Biocompatibility (ISO 10993-1, -5, -10, -11, -12, -23): | All tests met requirements, implicitly demonstrating biocompatibility. |
| - Cytotoxicity | Tested |
| - Sensitization | Tested |
| - Irritation | Tested |
| Packaging (ASTM D4169, Distribution Cycle 13, Assurance Level II): | Tested |
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.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”