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GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office.

GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office. GlassLok can be used to bond molar bands to an enamel or metal substrate in a wet or dry field due to its hydrophilic properties. GlassLok is available in natural or blue shade (for easy disclosure at removal).

GlassLok is dispensed in a 2 part (powder and liquid) format with bottle dispensing. A 15cc and 25 cc liquid (in blue or natural shade) along with a 15gm or 100gm powder component will be available as separate components. A convenience kit will also be available in Blue or Natural shade in a starter or economy volume.

GlassLok powder is dispensed to a mixing pad using a measuring scoop and mixed with GlassLok liquid in a ratio of 2:1. The mixed GlassLok composite is then applied to the inside of an orthodontic band and applied to a properly prepared tooth structure. Working Time is 2 minutes and setting time is 5 minutes once the working time has expired. GlassLok can also be cured with a curing light for 20 seconds, if required for polymerization.

Associated accessories include a measuring scoop. Spatula and mixing pad.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Met?": The document states that GlassLok demonstrated "similar or better performance" for shear bond strength and "similar results" for ISO 9917-2:2017 testing when compared to the predicate. For biocompatibility, it states the device "did not directly or through the release of material constituents produce adverse local or systemic effects; it is not carcinogenic or mutagenic, and will not produce adverse reproductive or developmental effects." This indicates the acceptance criteria were met.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the sample size used for the shear bond strength testing or the ISO 9917-2:2017 testing.
• Data Provenance: The document does not specify the country of origin of the data. It also does not state whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a new device, it would most likely be prospective, newly generated data for the purpose of the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The document describes laboratory performance testing (shear bond strength, ISO 9917-2:2017) and biocompatibility evaluations, not a study involving human interpretation where "ground truth" would be established by experts in the clinical sense (e.g., radiologists interpreting images).
• Therefore, this question is not applicable in the context of this device's evaluation as described. The "ground truth" here is objective physical and chemical measurements.

4. Adjudication Method for the Test Set

• As mentioned above, the primary evaluations were laboratory-based performance tests and biocompatibility assessments, not studies requiring expert adjudication of results.
• Therefore, this question is not applicable in the context of this device's evaluation as described.

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

• No, an MRMC comparative effectiveness study was not done.
• This device, GlassLok, is a dental cement, not an AI-powered diagnostic or decision support tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant.

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

• No, a standalone algorithm performance study was not done.
• GlassLok is a physical dental material, not an algorithm or software.

7. The Type of Ground Truth Used

• For performance testing (shear bond strength, ISO 9917-2:2017): The ground truth was based on objective physical and mechanical measurements obtained through standardized laboratory test methods. The predicate device served as the comparative benchmark.
• For biocompatibility: The ground truth was established through biological evaluations and chemical characterization against established international standards (ISO 10993 and ISO 7405:2018), determining whether the material caused adverse biological reactions.

8. The Sample Size for the Training Set

• This is a medical device (dental cement), not a machine learning or AI model. Therefore, the concept of a "training set" in the context of AI development is not applicable. The device's performance is inherent to its material properties and manufacturing, not learned from data.

9. How the Ground Truth for the Training Set Was Established

• As mentioned above, the concept of a "training set" is not applicable for this type of device. The characteristics and performance of GlassLok are determined through its chemical composition and physical properties, which are then verified through the performance data described.

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