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K Number
K111066
Device Name
MIGRA TAB, QUICKSPLINT MIGRAINE
Manufacturer
MIGRATHERAPY LLC
Date Cleared
2011-11-22

(218 days)

Product Code
MQC
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
K040315,K014079
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Protection of teeth and restorations from injury due to bruxism or clenching.
  2. Temporary relief of Temporo Mandibular joint Disorder (TMD) and bruxism by reducing muscle tension.
  3. Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
Device Description

The Brux-TMD QuickSplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid though bicuspid. It is a two-component device with a hard plastic shell and a softer compliant lining that conforms to the supporting teeth. The operator may optionally place it on the anterior maxillary or mandibular arch. The Brux-TMD QuickSplint is easily and quickly assembled in a provider's office for same day use by the patient. While it is worn, the Brux-TMD QuickSplint temporarily inhibits the full force of parafunctional teeth clenching, and gives the pericranial musculature an opportunity to relax. This reduces the muscular tension that underlies the pain associated with many bruxism headaches and the pain associated with TMD dysfunction. It reduces the muscle tension in trigeminal innervated cranial-facial muscles, thereby reducing the pain occurrence. In addition, it physically protects the teeth from nighttime bruxing activities by covering the dental occlusal surfaces with a durable plastic covering.

AI/ML Overview

The provided text describes a medical device, the Brux-TMD QuickSplint, and its FDA 510(k) premarket notification. However, it does not contain information about acceptance criteria, a study that proves the device meets specific acceptance criteria, or any details related to AI performance metrics.

The document focuses on:

  • Device Description: The physical characteristics and mechanism of action of the Brux-TMD QuickSplint.
  • Intended Use: The conditions the device is designed to address (bruxism, clenching, TMD, associated pain and headaches).
  • Comparison to Predicate Devices: A table comparing the Brux-TMD QuickSplint to existing, legally marketed devices, highlighting similarities in indications, design, use, reusability, disinfection methods, and risk.
  • FDA 510(k) Clearance: The formal letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

The document primarily addresses the substantial equivalence of the new device to existing ones, a regulatory pathway that often relies on demonstrating similar characteristics and intended use rather than conducting new, extensive performance studies against specific acceptance criteria, especially for unclassified devices like this one.

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