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Light Cure Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures:

• Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives;
• Repair of dental restorations of ceramic, composites and/or metal alloys;
• Indirect dental restoration applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a "Light Cure Adhesive" device, which is a dental bonding agent. It discusses regulatory matters, such as substantial equivalence, general controls, and good manufacturing practices.

It does not include details about:

• Acceptance criteria table and reported device performance for a study proving the device meets the criteria.
• Sample sizes or data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or how its ground truth was established.

This document is a regulatory approval, not a clinical or performance study report for an AI/software-based medical device. Therefore, I cannot extract the requested information from the given text.

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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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