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LiquiBand® Dental n-butyl cyanoacrylate is intended for use as an adhesive when bonding of caps and crowns to teeth is desired.

The LiquiBand® Dental adhesive formula consists of n-butyl cyanoacrylate monomer containing small amounts of hydroquinone (a free radical inhibitor) and sulfur dioxide (an anionic inhibitor).

LiquiBand® Dental, n-butyl cyanoacrylate adhesive, is a clear, colorless, free-flowing liquid packaged in a single use, 0.5 gram high density polyethylene ampoule with an attachable polypropylene applicator tip. It is applied as a liquid monomer to the bonding surface of the cap/crown to be cemented to a tooth. Upon seating the cap/crown and contact with weak bases LiguiBand® Dental polymerizes as to form a strong adhesive bond between the cap/crown and tooth.

The provided text describes a 510(k) submission for the LiquiBand® Dental adhesive, comparing it to a predicate device, OCTYLDENT® Dental Adhesive. The submission focuses on demonstrating substantial equivalence rather than establishing new acceptance criteria or conducting extensive clinical trials as would be common for novel devices.

Therefore, many of the typical elements of acceptance criteria and study design (like sample sizes for test and training sets, expert qualifications, MRMC studies, or standalone performance) are not detailed because they were not the focus of this type of regulatory submission.

Here's an analysis based on the information provided, with an emphasis on what is present and what is absent:

Acceptance Criteria and Device Performance

The core acceptance criterion for a 510(k) submission is substantial equivalence to a predicate device. This is demonstrated by showing similar intended use, materials, application methods, and performance in nonclinical testing.

Study Details for Substantial Equivalence

This is not a study to prove acceptance criteria for a novel device, but rather a submission to prove substantial equivalence to a legally marketed predicate device.

1. Sample sizes used for the test set and the data provenance: Not specified. The "test set" in this context refers to the samples used in the nonclinical chemical, physical, and biocompatibility testing. The document does not provide details on the number of samples tested for each assay or their provenance beyond being part of the manufacturer's testing. It is retrospective testing of the developed device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a 510(k) nonclinical testing submission. No experts were used to establish "ground truth" in the clinical sense, as no clinical human data is presented or implied for the substantial equivalence claim. The "ground truth" or reference for the comparative nonclinical tests would be the established properties of the predicate device.

3. Adjudication method for the test set: Not applicable. There was no clinical trial or expert review panel described.

4. 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: Not applicable. This is not an AI/medical image analysis device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (dental adhesive), not an algorithm. The nonclinical tests conducted can be considered "standalone" in that they assess the device's inherent physical, chemical, and biological properties without human intervention during the "performance" phase of the test itself.

6. The type of ground truth used:

   • For the nonclinical testing (chemical, physical, biocompatibility): The "ground truth" was implicitly established by comparing the results of LiquiBand® Dental adhesive to the known, established properties and performance of the legally marketed predicate device, OCTYLDENT® Dental Adhesive. The predicate device's existing regulatory status and performance data serve as the benchmark.
   • For the intended use, material, and application method comparison: These were directly compared to the stated characteristics of the predicate device.

7. The sample size for the training set: Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

8. How the ground truth for the training set was established: Not applicable.

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