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The O'Brien MPA is intended to reduce snoring and to treat mild to moderate obstructive sleep apnea. This individually fabricated, non-sterile prescription device is a single patient, multi-use product for use at home or in a sleep laboratory.

The O'Brien MPA is made of thermal plastic material (ADA approved materials). It is a very simple device that fits snugly over the upper and lower anterior teeth in such a way as to keep the mandible in a stationary, anterior protrusive position. The reason for this is to physically open the airway and thus potentially reduce the occurrence of snoring and sleep apnea. (This theory of airway management is common, standard operating procedures in the emergency medical field for airway management purposes.) The device also includes air channels to allow breathing through the mouth.

The provided 510(k) summary for the O'Brien MPA (Mandibular Positioning Appliance, K060744) does not contain information regarding acceptance criteria, a study proving the device meets acceptance criteria, or any details about a clinical study's methodology.

This 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices (SUAD - K023836, TAP - K962516, OASYS - Oral Airway System - K030440) based on similar design principles, materials, and intended use. The document describes the device, its intended use (reducing snoring and treating mild to moderate obstructive sleep apnea), and the regulatory classification.

Therefore, I cannot populate the table or answer the subsequent questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth. These types of details are typically found in a clinical study report, which is not part of this 510(k) summary.

Summary of what is NOT in the provided document:

• Acceptance Criteria for Device Performance: The document does not define specific metrics (e.g., percentage reduction in AHI, success rate for snoring reduction) that the O'Brien MPA must achieve.
• Study Proving Acceptance Criteria: No study is described that was designed to demonstrate the device meets any performance criteria.
• Device Performance Data: There are no reported numerical results or performance statistics for the O'Brien MPA regarding its effectiveness in reducing snoring or treating sleep apnea.
• Sample Size for Test Set: Not applicable as no clinical study is detailed.
• Data Provenance: Not applicable.
• Number of Experts for Ground Truth: Not applicable.
• Qualifications of Experts: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No such study is mentioned.
• Standalone Performance Study: No details of any performance study are provided.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• Ground Truth for Training Set: Not applicable.

The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for every submission, particularly if the technology is well-understood and the risks are manageable. In this case, the FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This indicates that the approval was based on equivalence, not necessarily on a new clinical study demonstrating specific performance against predefined acceptance criteria for the O'Brien MPA itself.

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