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The Kava and Kava with Herbst device(s) are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Kava and Kava with Herbst 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 Kava and Kava with Herbst are intra-oral devices used for treating snoring 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.

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

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.

The provided text relates to a 510(k) premarket notification for a medical device called "Kava and Kava with Herbst." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria against well-defined acceptance criteria in the manner requested (e.g., an AI/ML device's diagnostic performance).

Therefore, the document does not contain the information requested in the prompt regarding:

• A table of acceptance criteria and reported device performance for diagnostic accuracy (e.g., sensitivity, specificity). Instead, it discusses the device's physical and material properties (strength, elongation, biocompatibility) and its intended therapeutic function (reducing snoring and OSA by mandibular repositioning).
• Sample sizes for test sets used for diagnostic performance evaluation or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or effect sizes for human readers with AI assistance.
• Whether standalone performance was evaluated.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

This is a physical medical device (an intraoral appliance), not a diagnostic AI/ML system. The "performance testing" referred to in the document focuses on engineering and material testing (e.g., tensile strength, flexibility, biocompatibility), which are relevant for the safety and function of a physical device, but not for the diagnostic performance metrics typically associated with AI/ML-based medical devices as implied by the prompt's structure.

The document's purpose is to demonstrate substantial equivalence to predicate oral appliances for snoring and OSA, based on similar indications for use, principles of operation, technological characteristics, and material safety. It confirms the device passed a series of non-clinical performance tests related to its physical and biological properties.

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