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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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TP Orthodontics Clear Aligner System consists of a series of plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, TP Orthodontics Clear Aligner System sequentially positions teeth by way of continuous gentle force.

TP Orthodontics Clear Aligner System consists of a custom-made series of plastic aligners that apply gentle pressure to teeth, gradually moving them into alignment. A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to TP Orthodontics along with the physician's prescription. TP Orthodontics, using a standard dental software used for teeth alignment, designs a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription. The set-up and intermediate stages are sent back to the physician for review and approval. Once the doctor has approved the model scheme, the aligners are produced using a thermoplastic material and shipped to the dental practitioner. The doctor delivers the aligners to the patient in sequential stages, provides instructions for use (such as when to change aligners), and monitors the case progression and fit and function from the first aligner through the end of treatment through follow-up appointments. Aligners must be worn by the patient most of the day (20-22h), being removed only for eating, drinking and performing oral hygiene and should be replaced every 2-3 weeks as prescribed by the doctor.

This document describes the FDA's 510(k) clearance for the TP Orthodontics Clear Aligner System and its substantial equivalence to predicate devices, thus the information provided focuses on the regulatory submission rather than a detailed scientific study. Therefore, some of the requested information regarding a device's performance study might not be explicitly present if it deviates from what is typically required for a 510(k) submission.

Here's the summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to predicate devices. For this type of device (clear aligners), this primarily involves demonstrating equivalent indications for use, technological characteristics, and safety profiles.

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

The document explicitly states: "therefore there was no clinical testing to support this device." This means there was no specific test set of patients used for a clinical performance study of the TP Orthodontics Clear Aligner System. The device's clinical performance relies on the established performance of predicate devices.

For the non-clinical manufacturing validation, the sample size is not specified, nor is the data provenance.

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

Not applicable as no specific clinical 'test set' was used for this device in a de novo study. The ground truth for the overall category of sequential aligners (NXC) would have been established through years of clinical practice and research by orthodontists and dental professionals, leading to the FDA's clearance of the first device in 1998.

4. Adjudication Method for the Test Set

Not applicable as no specific clinical 'test set' was used for a new study on this device.

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 a physical medical device (clear aligner system), not an AI-assisted diagnostic or treatment planning system that would involve human "readers" or AI assistance in the way typically discussed in a MRMC study. The software mentioned is for designing the aligners, not for diagnostic interpretation by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable for a physical clear aligner device. The "software" mentioned passed its validations, which would imply standalone testing of the software's functionality, but this is not an "algorithm only" performance for diagnosis or treatment decision making in the typical sense.

7. The Type of Ground Truth Used

For the specific device, the ground truth for regulatory clearance was demonstration of substantial equivalence to predicate devices. This means that its design, materials, manufacturing, indications for use, and overall safety and effectiveness were compared against devices already legally marketed and proven effective.

For the manufacturing validation, the ground truth would be the software output specifications (i.e., the aligners were produced accurately according to the digital design).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set" in the computational sense. The design of the aligners is based on dental software that applies established biomechanical principles and clinician input, not a data-driven training set.

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

Not applicable, as no computational "training set" was used for this device.

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The Click-It ceramic self-ligating bracket is intended to be used in an orthodontic treatment with the aim of moving teeth.

The Click-It ceramic self-ligating bracket is intended to be used in an orthodontic treatment with the aim of moving teeth. The basic function is the same as the orthodontic brackets for which substantial equivalence is claimed such that the movement of the tooth and remodeling of the mandibular and maxillary bone will occur when gentle sustained pressure is applied to the teeth through the bracket and wire system. The Click-It ceramic self-ligating bracket has self-ligating properties and will include maxillary and mandibular brackets from second bicuspid to second bicuspid. The device consists of a polycrystalline alumina bracket with two polycrystalline alumina jaws, a nickel titanium spring and two nickel titanium pins.

The design of a self-ligating bracket enables the archwire to be ligated to the bracket without the use of auxiliary devices such as wires or elastics. It enables quicker archwire placement without any significant change in the mechanics when compared to the devices for which substantial equivalence is claimed.

As its predicates, Click-It ceramic self-ligating bracket enables several types of tooth movements throughout the treatment such as: tipping, translation (bodily movement), torque, extrusion, rotation, and intrusion.

The Click-It ceramic self ligating brackets are bonded to the buccal and labial surface of teeth and enable the orthodontic treatment.

The provided document describes a 510(k) premarket notification for a medical device, the "Click-It Ceramic Bracket," an orthodontic bracket. It focuses on establishing substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in a traditional sense (e.g., using a test set with ground truth established by experts).

Therefore, many of the requested elements (e.g., sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) are not applicable or not provided in this type of submission. The submission primarily relies on bench and laboratory testing to compare the new device's performance to its predicates and ensure it functions similarly and safely.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by performing "similar to" or "as well as or better than" the predicate devices. The reported device performance is a direct comparison to the predicates in various bench tests.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated for each test. For example, for "Shear Bond Strength," an "Average 12.44 Mpa" is given, implying a number of tests were conducted to calculate an average, but the sample size (n) is not provided.
• Data Provenance: The document describes "Bench and laboratory testing" conducted by TP Orthodontics, Inc. (the manufacturer). This is prospective testing specifically designed for the 510(k) submission. The country of origin of the data is implicitly the USA, where the testing was likely overseen, corresponding to the manufacturer's location.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This type of device relies on engineering and material performance testing rather than expert-derived ground truth or clinical outcomes. The "ground truth" for these tests is based on established engineering standards (e.g., ISO 11405 for bond strength) and measurable physical properties.

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

• Not Applicable. As the tests are based on objective physical measurements and comparisons to standards or predicate devices, there is no expert adjudication process in this context.

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 hardware medical device (orthodontic bracket) and does not involve AI or human readers for diagnostic interpretation.

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

• Not Applicable. This device is a physical orthodontic bracket, not an algorithm.

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

• The "ground truth" for these tests is based on established engineering and material science standards and physical measurements. For example, shear bond strength is measured against the ISO 11405 standard, and biocompatibility is assessed against ISO 10993. The "performance" of predicate devices also serves as a benchmark for comparison.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. The development process involves design, material selection, and then bench testing, not machine learning or algorithm training.

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

• Not Applicable. As there is no training set, this question is not relevant.

In summary: The provided document is a 510(k) summary for an orthodontic bracket, which establishes substantial equivalence through bench and laboratory performance testing against legally marketed predicate devices and international standards, rather than clinical studies involving expert-adjudicated ground truth or AI performance metrics.

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