(558 days)
The TRIOCLEAR System is a series of clear, lightweight, 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 movement, it sequentially positions teeth by way of continuous gentle force.
The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
The information provided describes the TRIOCLEAR System, an orthodontic clear aligner device, and its substantiation for 510(k) clearance. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical performance context typically seen for diagnostic AI.
However, based on the provided text, we can glean information relevant to your request, particularly regarding physical properties testing and validation.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Properties Testing | |
| Tensile strength (according to ISO 527-2) | Met acceptance criteria |
| Modulus (according to ISO 527-2) | Met acceptance criteria |
| Elongation (according to ISO 527-2) | Met acceptance criteria |
| Hardness (according to ASTM D785) | Met acceptance criteria |
| Humidity absorption (immersion in distilled water for 24 hours at 23°C) | Met acceptance criteria |
| Validation of Digital and 3D Printed Models & Thermoformed Aligners | |
| Differences calculated using CAD overlay method | All aligners fabricated met pre-defined acceptance criteria |
| RMS calculations | All aligners fabricated met pre-defined acceptance criteria |
| Form and fit of thermoformed aligners | Received an A grade |
| Biocompatibility Testing | |
| Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing |
| Irritation | Non-irritant |
| Acute Systemic Toxicity | No acute systemic toxicity |
| Pyrogenicity | Non-pyrogenic |
| Subacute Toxicity | No subacute repeated exposure systemic toxicity |
| Implantation | Non-irritant when compared to implanted negative control article |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the physical properties testing or the validation of digital/3D printed models and aligners. It also does not specify the provenance (country of origin, retrospective/prospective) of any data used beyond stating that "Physical properties testing was conducted on the device" and "Validation was performed on the digital and 3D printed models, as well as the thermoformed aligners." Since this is a submission from Hong Kong, it is likely the testing was conducted there, but this is not explicitly stated for the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The study focuses on physical and material properties and validation of the manufacturing process, rather than a clinical performance study with expert ground truth. The "pre-defined acceptance criteria" for aligner validation and "A grade for form and fit" would imply an internal standard or expert assessment, but details are absent.
4. Adjudication method for the test set
This information is not applicable or provided. The testing described is primarily objective physical and material properties, and validation of manufacturing accuracy. There is no mention of an adjudication method typical for human-interpreted diagnostic tasks.
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
No such study was conducted or described in this document. The TRIOCLEAR System is an orthodontic appliance, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical clear aligner system. There is a "digital design" phase where "Perfection designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription," and "The prescribing physician reviews and approves the model scheme before the molds are produced." While this involves digital tools, it's a design and manufacturing process, not an AI algorithm performing a standalone diagnostic task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical properties and material testing, the "ground truth" is defined by established international standards (ISO 527-2, ASTM D785) and internal "pre-defined acceptance criteria." For the validation of the digital and 3D printed models and aligners, the ground truth for comparison appears to be the intended design (physician's prescription transformed into a digital model), against which the actual fabricated products (digital models, 3D printed models, thermoformed aligners) are measured using CAD overlay and RMS calculations.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that involves a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI algorithm.
§ 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.