(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.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
July 06, 2021
Perfection Aligner System Hong Kong Limited Alwin Ngai Director Flat/Rm 4B, 4/F, Hang Fat Industrial Building, 550-556 Castle Peak Road Kowloon, HONG KONG
Re: K193622
Trade/Device Name: TRIOCLEAR System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 10, 2021 Received: June 2, 2021
Dear Alwin Ngai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K193622
Device Name TRIOCLEAR System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable):
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K193622
Section 5: 510(k) Summary
1. Submitter Information
| Company Name: | Perfection Aligner System Hong Kong Limited |
|---|---|
| Company Address: | Flat/Rm 4B, 4/F, Hang Fat Industrial Building550-556 Castle Peak Road, Kowloon, Hong Kong |
| Company Phone: | (852) 3766 0737 |
| Company Fax: | (852) 2577 7511 |
| Contact Person: | Mr. Alwin Ngai |
| Email: | alwin.ngai@moderndentalgp.com |
| Date Prepared | June 29, 2021 |
2. Device Identification
| Device Model Name: | TRIOCLEAR System |
|---|---|
| Classification Name: | Orthodontic Plastic Bracket |
| Regulation Number: | 872.5470 |
| Product Code: | NXC |
| Class | II |
| Panel | Dental |
3. Predicated Devices
| Primary Predicate: | 3MTM Clear Tray Aligner, K163689 |
|---|---|
| Reference Device: | eCligner®, K143499 |
4. Device Description
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.
5. Indications for Use
The TRIOCLEAR System is a series of clear, lightweight, plastic appliances
510(k) Files: Section 5
Page 1 of 7
{4}------------------------------------------------
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.
6. Mechanism of Action
The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence. Orthodontic tooth movement occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.
7. Technological Characteristics
A dental health care professional (e.g. orthodontist or dentist), prescribes the TRIOCLEAR System based on an assessment of the patient's teeth, determines a course of treatment with the system, takes physical or optical measurements of the patient's teeth and completes a prescription from. The measurements and prescription are sent to Perfection.
Utilizing standard dental software used for tooth alignment. Perfection designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Perfection produces the trays, which are formed of clear, thin thermoformed plastic. The trays are sent back to the dental health care professional, who then provides them to the patient, confirming fit and design. Over a period, additional trays are provided sequentially to the patient by the dental health care professional to gradually move the target teeth to the desired position.
The dental care professional monitors treatment from the moment the first aligner is delivered to when treatment is completed. The trays are held in place by pressure and can be removed by the patient at any time.
This technology is essentially identical to that used by a number of sequential alignment systems, including the predicated referenced below.
8. Performance Testing
510(k) Files: Section 5
{5}------------------------------------------------
Physical properties testing was conducted on the device. Tensile properties (tensile strength, modulus and elongation) were tested according to ISO 527-2. Hardness was tested according to ASTM D785. Humidity absorption was tested by immersion of specimen in distilled water during 24 hours at 23°C. All results of the above tests met the acceptance criteria.
The substantial equivalence of the device is supported by non-clinical testing. Validation was performed on the digital and 3D printed models, as well as the thermoformed aligners and the differences were calculated using a CAD overlay method and by using RMS calculations. All aligners fabricated met the pre-defined acceptance criteria and received an A grade for form and fit of the thermoformed aligners.
9. Biocompatibility Testing
The biocompatibility evaluation for the final finished device was conducted in accordance with the US FDA CDRH Guidance Document Number 1811 "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process - Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA.
The TRIOCLEAR System is considered mucosal membrane direct contacting for a duration of greater than 30 days. The battery of testing included following tests:
- Cytotoxicity ●
- Sensitization ●
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Subacute Toxicity
- Implantation
The result of the testing met the requirements of study plan and the TRIOCLEAR System is considered non-cytotoxic, non-sensitizing, nonirritant, no acute systemic toxicity, non-pyrogenic, no subacute repeated exposure systemic toxicity, and nonirritant when compared to implanted negative control article.
10. Substantial Equivalence Comparison
510(k) Files: Section 5
{6}------------------------------------------------
The following table compares the TRIOCLEAR System to the predicate devices 3M™ Clear Tray Aligner and eCligner® with respect to indications for use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
{7}------------------------------------------------
| Elements ofComparison | Subject Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| Name | TRIOCLEAR System | 3M™ Clear Tray Aligner | eCligner® |
| 510(k) Number | K193622 | K163689 | K143499 |
| Manufacturer | Perfection Aligner System Hong KongLimited | 3M Unitek Corporation | eClear International Co., Ltd. |
| RegulationNumber | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 |
| DeviceClassificationName | Orthodontic plastic bracket | Orthodontic plastic bracket | Orthodontic plastic bracket |
| ClassificationProduct Code | NXC | NXC | NXC |
| Device Class | Class II | Class II | Class II |
| Indications forUse | The TRIOCLEAR System is a series of clear,lightweight, plastic appliances indicated forthe treatment of tooth malocclusions inpatients with permanent dentition (i.e. allsecond molars). Utilizing a series ofincremental tooth movement, it sequentiallypositions teeth by way of continuous gentleforce. | 3M™ Clear Tray Aligner is a series of clear,lightweight, plastic appliances indicated for thetreatment of tooth malocclusions in patientswith permanent dentition (i.e. all secondmolars). Utilizing a series of incremental toothmovement, it sequentially positions teeth byway of continuous gentle force. | eCligner® is a series of clear, lightweight,plastic appliances indicated for thecorrection of dental malocclusion inpatients with permanent dentition (i.e. allsecond molars). The eCligner® System isintended for minor anterior toothmovement by way of continuous gentleforce. |
| Material ofFabrication | Thermoplastic | Thermoplastic | Thermoplastic |
| MaterialProperties | Demonstrates sufficient tensile strength,ductility, chemical resistance, and clarity forsue as a clear tray aligner. | Demonstrates sufficient tensile strength,ductility, chemical resistance, and clarity forsue as a clear tray aligner. | Demonstrates sufficient tensile strength,ductility, chemical resistance, and clarityfor sue as a clear tray aligner. |
| Design | Image: Clear aligners arranged in a loose S shape | Image: Clear aligners arranged in a loose S shape | Image: Clear aligner for the lower teeth |
| Mode of Action | Orthodontic tooth movement occurs throughforces applied by the appliance to thedentition as each tooth follows theprogrammed displacement based on doctor'sprescription.Three steps aligners will be worn by patientfor each set. | Orthodontic tooth movement occurs throughforces applied by the appliance to the dentitionas each tooth follows the programmeddisplacement based on doctor's prescription.One single aligner will be worn by patient foreach set. | Orthodontic tooth movement occursthrough forces applied by the applianceto the dentition as each tooth follows theprogrammed displacement based ondoctor's prescription.Three steps aligners will be worn bypatient for each set. |
| TechnologicalCharacteristics | Treatment of tooth malocclusion is via aseries of plastic appliances that incrementallymoves teeth to a desired end-state. | Treatment of tooth malocclusion is via a seriesof plastic appliances that incrementally movesteeth to a desired end-state. | Treatment of tooth malocclusion is via aseries of plastic appliances thatincrementally moves teeth to a desiredend-state. |
| OTC or Rx | Rx | Rx | Rx |
510(k) Files: Section 5
{8}------------------------------------------------
{9}------------------------------------------------
11. Substantial Equivalence Conclusion
Based on the indications for use and performance information provided in this submission, demonstrates that the TRIOCLEAR System is as safe, as effective, and is substantially equivalent to the predicate devices.
§ 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.