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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 OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor is intended to reduce snoring and mild to moderate obstructive sleep apnea (OSA) and monitor patient usage in an adult population.

The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor are simple hardware devices. They are oral appliances and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients.

The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor are intraoral devices used for treating and mild to moderate Obstructive Sleep Apnea (OSA). They consists of two custom fitted trays which fit over the upper and lower dentition of a patient and engage by means of adjustable metal screws or lugs. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air. Additionally nasal dilator buttons are attached to the upper appliance, that when engaged stretch the nasio-label tissue in order to increase space in the nasal airway passage thus reducing tissue obstructions that aid in reducing snoring and OSA.

The devices are retained on the teeth by labial and lingual positioned ball clasps, typically located in the undercuts of each splint and by the base material engaging the undercuts of the teeth.

The devices are custom made for each patient and have an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

Additionally, the devices include the Dentitrac ® patient monitoring system as characterized under the Braebon Dentitrac MAF 2557 to help monitor patient compliance to prescribed usage.

The provided text describes a 510(k) submission for the "OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor". This submission focuses on demonstrating substantial equivalence to a predicate device and does not involve a clinical study with specific acceptance criteria that would typically be found in direct performance evaluations of a new medical device's efficacy or diagnostic accuracy. Instead, the "acceptance criteria" are related to established safety and performance standards for similar devices and the successful integration of the monitoring system.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not describe a test set or data provenance in the context of a clinical study or performance evaluation with human subjects for the OASYS device itself. The evidence presented is primarily based on:

• Comparison to predicate devices: This involves structural and functional similarities, and the predicate device (K030440) served as the primary benchmark.
• Non-clinical testing: This refers to laboratory-based evaluations for biocompatibility, electrical safety, software, and general performance. The text does not specify sample sizes for these tests (e.g., how many units were tested for biocompatibility, though such tests are typically conducted on representative samples).
• Reference to Master File (MAF 2557): The DentiTrac® Patient Monitoring System's specific testing details (biocompatibility, electrical, performance, and characterization) are contained in a larger "Master File," which is a confidential document submitted to the FDA. The details of any test sets or sample sizes within that MAF are not disclosed in this summary.

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

This information is not applicable as the submission is a 510(k) for substantial equivalence, relying on non-clinical testing and comparison to existing devices rather than a de novo clinical study requiring expert-established ground truth on a test set.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

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

This information is not applicable. The device is an oral appliance for treating snoring and sleep apnea, and a DentiTrac® monitoring system. It is not an AI-assisted diagnostic or assistive technology that would involve "human readers" or an MRMC study.

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

This information is not applicable. The DentiTrac® system monitors patient usage; it's a data collection system rather than an algorithm performing a diagnostic or assistive function that would have "standalone performance" in the context of AI.

7. The Type of Ground Truth Used

For the biocompatibility and performance testing, the ground truth is based on established international and national standards (e.g., ISO 10993-1, ISO 14971) and internal requirements/specifications. For the DentiTrac® system, the ground truth for its performance would be against its own specifications, validated as acceptable in MAF 2557, likely using calibrated instruments for accuracy of usage time measurement. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this 510(k) submission.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as the device is not an AI/machine learning system that requires training data.

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

This information is not applicable for the same reason as #8.

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