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TP Orthodontics Light Cure Adhesive System is indicated for use as an orthodontic bonding agent for metal brackets, ceramic brackets, and buccal tubes to the tooth's surface.

TP Orthodontics Pre-Applied Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment.

TP Orthodontics Echant is indicated for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

TP Orthodontics Light Cure Adhesive System and TP Orthodontics Pre-Applied Adhesive are light cure orthodontic adhesive used for bonding the orthodontic brackets, molar tubes, and buccal tubes to the surface of teeth for orthodontic treatment. The variations available are:

• . TP Orthodontics Light Cure Adhesive System, which consists of an adhesive paste (will be available in a pre-loaded syringe), and sealant.
• . TP Orthodontics Pre-Applied Adhesive, consisting of bracket adhesive pre-applied to the bracket pad.

The adhesives prevent bracket drift during placement, and is easy to clean-up excess (flash') prior to curing. The adhesive is polymerized ('cured') by exposure to a dental curing light, and once cured it creates a bond, attaching the orthodontic appliance to the teeth.

TP Orthodontics Etchant is a phosphoric acid etchant used on tooth enamel or dentin in preparation for orthodontic bonding. It is a blue gel and will be contained in a syringe, which will use disposable dispensing tips for its controlled application.

The provided text is a 510(k) summary for dental adhesive products and an etchant, not an AI/ML medical device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set information for an AI/ML device.

The document explicitly states:

• "No clinical performance testing was conducted on TP Orthodontics Light Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, and TP Orthodontics Etchant."
• "TP Orthodontics Light Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive and TP Orthodontics Etchant bench testing was performed. The proposed device passed testing and performed similar to its predicate devices (test reports are attached to this submission)."

This means the submission relies on bench testing demonstrating similarity to predicate devices, rather than clinical studies or AI/ML performance evaluations.

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3M™ Clarity™ Ultra Brackets and Adhesive Coated Appliance System are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

3M™ Clarity™ Ultra Brackets and Adhesive Coated Appliance System are intended for use in orthodontic treatment. Clarity Ultra Bracket is an esthetic bracket with a sliding door. The brackets are composed of aluminum oxide, which gives them a clear appearance. A nickel titanium wire serves as part of the door mechanism and is attached to the bracket using a cured adhesive. The brackets incorporate a water-soluble color placement indicator system. The archwire slot, vertical slot, and door are marked to facilitate bracket positioning. Tie wing(s) and/or door are color coded with dots to facilitate bracket identification. The brackets are available with or without APC™ Flash-Free pre-coated adhesive. The pre-coated adhesive ensures a consistent amount of adhesive on the bracket.

The provided document is a 510(k) Summary for the 3M™ Clarity™ Ultra Self-Ligating Brackets and Adhesive Coated Appliance System. It details the device's technical specifications and a comparison to predicate devices, but it does not contain information typically found in a study proving a device meets acceptance criteria, particularly for AI/machine learning devices.

The document discusses "Performance Testing" which refers to bench testing of mechanical properties, not clinical performance or AI algorithm performance. Therefore, I cannot extract information related to AI acceptance criteria or studies from this document.

For completeness, I will extract what is available regarding the device's performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Bench testing consistent with the clinical application and intended use was used to evaluate the performance of Clarity™ Ultra Self-Ligating Brackets and Adhesive Coated Appliance System compared to the predicate devices, Clarity™ Advanced and Damon 4Clear. Properties evaluated include: rotation play angle, wire rotation strength, shear-peel bond strength, torque strength, and squeeze debond strength. 3M Health Care has tested Clarity™ Ultra Self-Ligating Brackets and Adhesive Coated Appliance System and has concluded that the performance tests results demonstrate substantial equivalence to the predicate devices."

However, specific numerical "acceptance criteria" values or "reported device performance" values for these properties are not provided in the document. It only states that the device was found to be "substantially equivalent" to the predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing on the device itself, not a test set of data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant to this bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 device is not an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to mechanical bench testing. The "ground truth" in this context would be the measured mechanical properties of the devices.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm.

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

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