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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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This Device is intended for use as a light cure, orthodontic adhesive.

This device is a light-cure orthodontic adhesive intended for bonding brackets and appliances to a tooth surface. This device will bond to any enamel, porcelain, composite or metal tooth surface that has been properly conditioned. This device will be available in push syringe or tips for preferences in dispensing.

The provided text describes a 510(k) submission for the "Quantum LB" orthodontic adhesive. The study aims to demonstrate substantial equivalence to a predicate device, Transbond XT.

Here's an analysis of the acceptance criteria and the study presented:

Quantum LB Orthodontic Adhesive - Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the Quantum LB device, as per the provided summary, is similar performance to the predicate device (Transbond XT) in shear bond strength. No specific numerical thresholds are given for this similarity, but the summary states it was achieved.

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

The document states an "in-vivo performance test method for shear bond strength" was used. However, it does not explicitly state the sample size for this test. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).

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

This section is not applicable as the study appears to be a laboratory/performance test, not one relying on expert interpretation for ground truth. The "ground truth" here is the measured shear bond strength, which is an objective, quantitative metric.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study focuses on direct performance comparison of the device against a predicate, not on the improvement of human readers with AI assistance.

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

This question is not applicable as the device is a physical orthodontic adhesive, not a diagnostic algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for the shear bond strength testing is the measured shear bond strength itself, which is an objective, quantitative outcome. For biocompatibility and cytotoxicity, the ground truth is established by the results of standardized biological assays (ISO 10993).

8. The Sample Size for the Training Set

This question is not applicable. The Quantum LB is a physical medical device, not a machine learning algorithm, so there is no "training set."

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

This question is not applicable as there is no training set for this type of device.

In summary, the provided document focuses on demonstrating the performance and safety of a new orthodontic adhesive by comparing it to an already legally marketed predicate device through physical and biological testing. It is a traditional medical device submission and does not involve AI or expert-based diagnostic performance studies.

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