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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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OASYS Oral Airway System is intended for use to reduce or eleviate snoring and obstructive sleep apnea.

The OASYS ORAL AIRWAY SYSTEM Anti-Snoring Device is composed of:

• Lower tray fitted over the lower teeth.
• Upper shield fitting in front of upper anterior teeth.
• Upper molded splint fitted over upper teeth.
• Connecting mechanism joining upper shield and lower tray.
• Extensions off shield which act as nasal dilators.

The provided document for the "OASYS-ORAL AIRWAY SYSTEM" (K030440) does not contain detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics. This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel safety and effectiveness through extensive clinical trials with predefined acceptance criteria.

The document primarily highlights the device's technical characteristics and intended use, comparing them qualitatively to predicate devices. There are no quantifiable performance metrics, sample sizes, expert ground truth details, or statistical analyses typically associated with proving acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions quantitatively based on the information provided. The document specifically states: "Literature supports the historical significance of oral devices that reposition the mandible and reduce and manage snoring as well as sleep apnea." This implies reliance on existing knowledge and predicate device performance rather than dedicated efficacy studies for this specific device in this submission.

However, I can extract information related to the device's intended use and the comparison to predicate devices, which implicitly serves as the "acceptance criteria" in a 510(k) context – demonstrating that the new device is as safe and effective as existing legally marketed devices.

Summary of Information from the Provided Document (K030440):

Since no specific acceptance criteria with quantifiable metrics and associated study data are presented in this 510(k) summary, I will interpret "acceptance criteria" in the context of a 510(k) submission as the attributes and intended uses for which the device needs to demonstrate substantial equivalence to its predicates. The "reported device performance" would then be its conformance to these attributes and uses as stated in the comparison.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided document does not mention any specific test set, sample size, or data provenance from a study conducted for this device. The submission relies on demonstrating substantial equivalence to predicate devices and general literature support for oral appliances.

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)

No test set is described, and therefore, no information is provided regarding experts or their qualifications for establishing ground truth.

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

No test set is described, and therefore, no information on adjudication methods is provided.

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

No MRMC study was conducted or reported in this 510(k) submission. This is not an AI-assisted device.

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

No standalone algorithm performance study was conducted or reported. This device is a mechanical oral appliance, not an algorithm.

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

No specific ground truth type is mentioned as no dedicated study data is presented for this device's performance. The submission relies on the established safety and effectiveness of predicate devices and general scientific literature on oral appliances for snoring and sleep apnea.

8. The sample size for the training set

No training set is described, as this is a mechanical device submission and not an AI/algorithm submission.

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

No training set is described, and therefore, no information on how ground truth was established for a training set is provided.

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