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3M Transbond Orthodontic Adhesive is a thixotropic, visible-light activated, radiopaque orthodontic adhesive. The product is stored in a multi-use syringe which is used with single-use dispensing tips.
3M Transbond Orthodontic Adhesive contains bisGMA, TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20 nm silica filler, a non-agglomerated/non-aggregated surface modified 75 nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).

AI/ML Overview

This document is a 510(k) Premarket Notification for a dental adhesive, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria and study designs typically associated with AI/ML device performance (e.g., sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance) is not available in the provided text.

The document discusses the substantial equivalence of the 3M™ Transbond™ Orthodontic Adhesive to legally marketed predicate devices. The acceptance criteria and testing described pertain to the physical and chemical properties of the adhesive.

Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance:

The document mentions the following performance parameters were tested:

Performance Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Shear Bond Strength (adhesion)	Not explicitly stated, but implied to be comparable to or better than predicate/reference devices.	"The performance bench studies and biocompatibility assessment show that the subject device is as safe, as effective, and performs as well as or better than the predicate and/or reference device." (Specific values are not provided in this summary.)
Depth of Cure (ISO 4049)	Not explicitly stated, but implied to be comparable to or better than predicate/reference devices.	"The performance bench studies and biocompatibility assessment show that the subject device is as safe, as effective, and performs as well as or better than the predicate and/or reference device." (Specific values are not provided in this summary.)
Three-Body Wear Resistance	Not explicitly stated, but implied to be comparable to or better than predicate/reference devices.	"The performance bench studies and biocompatibility assessment show that the subject device is as safe, as effective, and performs as well as or better than the predicate and/or reference device." (Specific values are not provided in this summary.)
Rheology	Not explicitly stated, but implied to be comparable to or better than predicate/reference devices.	"The performance bench studies and biocompatibility assessment show that the subject device is as safe, as effective, and performs as well as or better than the predicate and/or reference device." (Specific values are not provided in this summary.)
Biocompatibility Assessment	Successful completion according to relevant standards.	"The performance bench studies and biocompatibility assessment show that the subject device is as safe, as effective, and performs as well as or better than the predicate and/or reference device."

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified in this 510(k) summary. These details would typically be found in the full test reports, which are not included in this document.
Data Provenance: Not specified. These are bench studies, not patient data studies, so geographical origin or retrospective/prospective nature isn't typically relevant in the same way it would be for clinical AI/ML studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is a material science and engineering evaluation, not an AI/ML medical imaging device requiring human expert consensus for ground truth. The "ground truth" for these tests are objective measurements based on established dental material testing standards (e.g., ISO 4049).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not an AI/ML device requiring human adjudication of results.

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:

Not applicable. This is a dental adhesive, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical device, not an algorithm. The "performance" is inherent to the material itself, measured in laboratory settings without human interpretation assistance in the way an AI would be.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the performance tests (Shear Bond Strength, Depth of Cure, Three-Body Wear Resistance, Rheology) would be the objective measurements derived from standardized laboratory testing methods against established mechanical and chemical benchmarks for dental adhesives. This is not subjective expert consensus or patient outcomes data.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

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

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