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GluSite is indicated for use as dental cement for bonding dental materials such as crowns, caps, and pins, or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal disease.

GluSite (2-octyl cynoacrylate) is a clear colorless, free-flowing liquid monomer packaged in a glass multiple-use vials. Upon contact with weak bases, GluSite polymerizes to form a strong adhesive bond. Depending on the availability of moisture, this could take up to one minute.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GluSite device:

This document ([K013446](https://510k.innolitics.com/search/K013446)) is a 510(k) summary for a medical device seeking market premarket clearance. It is not a detailed study report, but rather a summary to establish substantial equivalence to a predicate device. Therefore, much of the requested information regarding detailed study design (sample sizes for training/test sets, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details) is not present in this document.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative "acceptance criteria" through a table of targets that the device had to meet. Instead, the core of the evaluation for a 510(k) is demonstrating substantial equivalence to a predicate device. The "performance" is reported as equivalent to the predicate.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified. It's common for 510(k) submissions to include bench testing or in-vitro tests, but the document doesn't detail the type or origin of this data. It only states "test results."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For a medical device like dental cement, "ground truth" would typically refer to objective measurements of physical properties (e.g., bond strength, setting time, solubility) rather than expert interpretation of images.

4. Adjudication method for the test set:

This information is not provided and is generally not applicable to the type of performance testing expected for a dental cement (which focuses on objective physical properties rather than subjective interpretations).

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:

• MRMC Study: No, an MRMC study was not conducted (and would not be relevant) for this device.
• Effect size of human readers with/without AI assistance: This is not applicable as GluSite is a dental cement, not an AI-powered diagnostic or assistive device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance Test: Not applicable in the context of an "algorithm only" device. However, the "test results" mentioned imply a standalone performance evaluation of the cement's physical properties. The document states "test results demonstrates that the two devices are equivalent in performance," which suggests direct comparison of the substance itself without a human-in-the-loop component.

7. The type of ground truth used:

The document implies that the ground truth for performance comparison was based on objective, measurable physical and chemical properties of the dental cement, such as those related to its claim of being equivalent to the predicate in "chemical composition" and "performance." For dental cements, these typically include properties like:

• Bond strength
• Setting time
• Solubility
• Film thickness
• Radiopacity
• Biocompatibility

8. The sample size for the training set:

Not applicable and not provided. As a physical dental cement, there is no "training set" in the machine learning sense. The device's performance is inherent to its material properties, not learned from data.

9. How the ground truth for the training set was established:

Not applicable and not provided. There is no training set for this type of device.

Summary of Key Takeaways from the document:

The provided 510(k) summary for GluSite focuses on establishing substantial equivalence to the predicate device, Octyldent®, based on:

• Equivalent intended use
• Equivalent chemical composition (both are 2-octyl cyanoacrylate)
• Undisclosed "test results" demonstrating equivalent performance.

The document does not delve into the detailed methodology of these "test results" regarding sample sizes, expert involvement, or adjudication methods, as its purpose is a high-level regulatory summary for equivalence.

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