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Opal® Bond MV is a light cure orthodontic adhesive designed for bonding brackets and other bondable appliances to etched enamel.

Opal® Bond MV is a light cure orthodontic adhesive.

The provided document is a 510(k) summary for a medical device (Opal® Bond MV, an orthodontic adhesive). It outlines the device's intended use and claims substantial equivalence to predicate devices based on various tests. However, it does not contain a table of acceptance criteria or specific performance metrics from a study that "proves the device meets the acceptance criteria" in the way one would expect for a more complex AI/software medical device.

The information provided describes the types of tests performed and states that a "detailed Clinical Summary" with supporting literature was included in the submission, but the details of this summary and specific performance results are not present in the excerpt.

Based on the provided text, here's what can be extracted and what information is missing:

1. Table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the excerpt. The document lists several tests performed (Shear Peel, Flexural Strength, Hardness, Shear Bond with bracket, Compressive, Metal Shear, Depth of Cure, Tensile Pull, Ambient Light Sensitivity, Clinic, Lab) and states that these were "compared to 3M Unitek's Transbond (K073697)". However, it does not detail:

• Specific acceptance criteria (e.g., "Shear Bond strength must be greater than X MPa").
• The actual quantitative results of Opal® Bond MV for these tests.
• The quantitative results of 3M Unitek's Transbond for comparison.

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

• Sample size for test set: Not specified in the provided text.
• Data provenance: Not specified in the provided text. It mentions "Clinical Summary" and "literature," implying some human data might be involved, but details are absent.

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 or Not specified. This device is an adhesive, and its performance would typically be measured through objective mechanical and chemical tests rather than expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would. If a "Clinic" test involved human assessment, the details are not provided.

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

• Not applicable or Not specified. This is a mechanical/chemical properties study, not a human reader study requiring adjudication.

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. This is not an AI device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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

• No. This is not an AI device.

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

• For the technical tests (Shear Peel, Flexural Strength, etc.), the "ground truth" would be established by standardized laboratory testing procedures and universally accepted scientific definitions of these material properties, measured using instruments.
• For the "Clinic" test, if it involved a clinical trial, the "ground truth" would likely be based on clinical outcomes relevant to orthodontic bonding (e.g., bracket retention, adverse events) assessed by clinical experts, but this is not detailed.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance is based on its material properties, developed through R&D (which might involve iterative testing, but not "training data" in the AI sense).

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

• Not applicable. As above, this is not an AI/machine learning device.

In summary:

The provided document details a Traditional 510(k) submission for an orthodontic adhesive. The "study" referenced involves a series of mechanical and chemical tests comparing the new device (Opal® Bond MV) to an existing predicate device (3M Unitek's Transbond). However, the specific quantitative results of these tests and the defined acceptance criteria are not included in this excerpt. The document implicitly claims that the device meets acceptance criteria by stating "substantial equivalence" based on these tests and supporting literature, but the raw data or detailed performance tables are omitted from this summary.

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