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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.
| Acceptance Criterion (Implicit) | Reported Device Performance (Click-It) | Comparison to Predicates |
|---|---|---|
| Bond Strength (ISO 11405:2003 (E)) | Average 12.44 Mpa | Comparable to predicate devices. De-bonding did not cause enamel damage, performs like predicates. |
| Friction (wire to bracket frictional characteristics) | Ranks second out of four bracket systems tested. | Closely follows Clarity SL, outperforms Damon 4Clear and In-Ovation C. |
| Escapement (wire escapement characteristics) | Performed as expected. | Similar to predicate devices. Retains wires in normal orthodontic procedures. |
| Impact (catastrophic disassembly) | Broke without causing patient harm. | Fractured similarly to predicate devices, not imparting shards into the mouth. |
| Pull Test (bracket/bond performance) | De-bonded by bond failing in shear at adhesive interface. | Performed as well as or better than predicate devices. Meets predefined acceptance criteria. |
| Archwire Slot Dimensional Comparison | Dimensionally similar. | Conforms to design specification. |
| Biocompatibility (ISO 10993) | Complies with ISO 10993. | Meets applicable biocompatibility requirements. |
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.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.