Search Results

Rest Assure is an intraoral device intended to be used in the treatment of snoring and mild to moderate obstructive sleep apnea in patients over 18. Rest Assure has the capability to record and monitor patient compliance to oral device/appliance therapy.

The SomnoDent intraoral devices functions as a mandibular repositioner, which acts to increase the patient's pharvngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to breather during sleep. The devices are patient specific (they are customized for each patient) and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the sleep dentist at the time of fitting the device. The devices can then be adjusted by the sleep dentist to control the treatment to find the best possible adjustment.

This Rest Assure System consists of two appliances, namely the Rest Assure Elite Appliance with (formerly the SomnoDent Herbst commercially distributed under K150369) and the Rest Assure Avant. Both hold current 510(k) clearances from FDA, K150369 for the SomnoDent Herbst Advanced with embedded micro-recorder and K183443 for the SomnoDent Avant.

The provided FDA 510(k) summary for the "Rest Assure System" does not contain the acceptance criteria and the study that proves the device meets those criteria in the format requested.

The document states that "clinical testing was not required or performed." Therefore, there is no clinical study described that would establish acceptance criteria for device performance based on patient outcomes, nor details on a clinical test set, expert adjudication, or MRMC studies.

The performance testing section (8.0) lists various engineering and regulatory compliance tests:

• A. Software Testing per IEC 62304
• B. Safety Testing by UL per 60601-1 series
• C. EMC Testing per 60601-1-2
• D. Risk Analysis per ISO 14971
• E. Cybersecurity Evaluation and Assessment
• F. Co-existence Testing and Assessment
• G. Biocompatibility Assessment
• H. Usability Testing per IEC 62366
• Further, functional and systems testing was performed to demonstrate requirements were successfully completed to demonstrate compliance with the device requirements and specifications.

These tests are primarily focused on safety, electromagnetic compatibility, usability, software quality, and biocompatibility, as per regulatory standards, rather than clinical performance metrics like sensitivity, specificity, or improvement in a medical condition. The document concludes that based on these engineering tests and the device's similarity to predicates, it is "safe and effective for its intended purpose."

Therefore, I cannot populate the table and answer the subsequent questions as the information is not present in the provided text.

Ask a specific question about this device

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.

Ask a specific question about this device

The Prosomnus [CA] Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The DentiTrac® micro-recorder is completely embedded into the Prosomnus [CA] Sleep and Snore appliance. The micro-recorder is intended to measure patient compliance to the oral appliance therapy in combination with the DentiTrac® System.

The Prosomnus [CA] Sleep and Snore device consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate sleep apnea by holding the mandible forward during sleep. providing increased pharyngeal space. These separate upper and lower arch devices are designed with twin-mated posts and are CAD/CAM generated specifically for each prescription. Designed as a patient-specific device, the Prosomnus [CA] Sleep and Snore device series consists of one or multiple lower device(s) together with one or multiple mated-post upper device(s) that are manufactured to the dentist prescriber's requested advancement positions up to 11mm to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing the current upper or lower device and inserting the next upper or lower device in the mandibular advancing series. The Prosomnus [CA] Sleep and Snore device twin-mated post and lingualess design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear.

This submission adds the option for an embedded screw that allows for smaller discreet movements of the mandible in between the lower arch advancements. The inclusion of the embedded screw does not change the intended use, impact the operating principles nor impact the fundamental scientific principles of the device as established by the predicate device K133683, the MicrO2 OSA device. The same principles of operation to move the mandible forward are used to increase pharyngeal space and maximize the tongue space.

The Prosomnus [CA] Sleep and Snore device includes an optional Micro-recorder to monitor patient compliance.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in relation to an AI algorithm or its effectiveness in reducing snoring and sleep apnea.

The document is a 510(k) premarket notification for the Prosomnus [CA] Sleep and Snore Device and the Prosomnus [CA] Sleep and Snore Device with Micro-recorder. The purpose of this notification is to demonstrate substantial equivalence to previously cleared predicate devices, not to prove direct clinical efficacy or performance against defined acceptance criteria in a clinical study.

The "Substantial Equivalence" sections (pages 5 and 9) describe the basis for deeming the devices substantially equivalent to their predicates. This equivalence is primarily based on:

• Identical Indications for Use: Both the predicate and the subject devices are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
• Technological Characteristics: The operating principles, materials, manufacturing process (digital milling), and mechanism to move the mandible forward are considered similar.
• In Vitro Testing: The document mentions "Compression and Shear Torsion Testing" and "Package and Distribution Testing" as data relied upon to determine substantial equivalence. These are mechanical and packaging tests, not clinical performance studies related to snoring or OSA reduction.

Therefore, I cannot provide the requested information as it is not present in the given text. The document does not describe:

1. A table of acceptance criteria and reported device performance for clinical outcomes.
2. Sample size for a test set for clinical performance or its provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human readers with/without AI assistance.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used for clinical efficacy (e.g., expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The "studies" mentioned are in vitro technical tests for mechanical integrity and packaging, not clinical performance studies in humans.

Ask a specific question about this device