Biotech Dental SMILERS® aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e., all second molars) during orthodontic treatment of malocclusion. SMILERS® aligners position teeth by way of continuous gentle force.

Device Description

The Biotech Dental SMILERS® aligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial position to a different end position using a software-generated sequence of intermediate states. Biotech Dental SMILERS® sequentially reposition teeth by way of continuous gentle force.

AI/ML Overview

The provided text is an FDA 510(k) summary for the Biotech Dental SMILERS® aligners. It focuses on demonstrating substantial equivalence to a predicate device (Byte Aligner System K180346) rather than detailing acceptance criteria and a study that proves the device meets them in the context of an AI/algorithm-driven device.

However, I can extract the information relevant to non-clinical performance testing and conceptualize how it relates to acceptance criteria and "proving the device meets them," even if it’s not an AI performance study.

Key takeaway from the document: This submission is for orthodontic aligners, which are physical medical devices, not an AI/algorithm. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to manufacturing validation, material testing, and shelf-life studies, not clinical performance or AI algorithm performance. The FDA determined that no clinical data was needed due to the well-established nature of sequential aligners.

Therefore, the requested information points 1 through 9, which are largely geared towards AI/algorithm performance studies, are not explicitly present in the provided document in the way they would be for an AI-medical device. I will address them based on the information available and note where it's not applicable.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for a Physical Device)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Non-Clinical)	Reported Device Performance and Study Type
Manufacturing Dimensional Accuracy	Study Type: Manufacturing ValidationPerformance: Demonstrated dimensional accuracy of the manufacturing process for SMILERS®. Cases were planned using Nemocast software and standard manufacturing protocols were followed. The validation evaluated dimensional accuracy of manufacturing aids and the final finished device.Met Acceptance Criteria: Yes (explicitly stated: "Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above.")
Device Fit	Study Type: Fit ValidationPerformance: Treatment-planned and manufactured aligner cases were qualitatively evaluated by a qualified individual to determine if the Subject device performs as intended.Met Acceptance Criteria: Yes (explicitly stated: "Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above.")
Shelf-Life/Material Degradation	Study Type: Shelf-life/Aging StudyPerformance: Assessed the impact of time-dependent material degradation within the stated shelf-life of the device.Met Acceptance Criteria: Yes (explicitly stated: "Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above.")
Biocompatibility (Material Safety)	Study Type: Biocompatibility Evaluation and Testing (according to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-18, ANSI/AAMI ST72)Specific Tests Performed: Cytotoxicity, Sensitization, Irritation, Endotoxins, Chemical Characterization.Performance: Not detailed, but the document states: "Biocompatibility evaluation and testing for the aligner material was conducted in accordance with International Standard ISO 10993-1... A chemical characterization was performed... The following biological tests were performed..."Met Acceptance Criteria: Yes (explicitly stated: "Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above.")

Regarding AI/Algorithm-Specific Questions (Not Applicable to this Device Approval, but addressed for completeness):

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not Applicable (N/A): This submission is for a physical medical device (orthodontic aligners), not an AI algorithm. No test set of clinical data (images, etc.) for AI performance was used. The "test set" for this application refers to physical samples used in manufacturing validation and biocompatibility testing. The number of cases for manufacturing validation is not specified, nor is the provenance of those cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

N/A: As this is physical device approval, there's no clinical "ground truth" established by experts in the context of an AI algorithm's diagnostic performance. For the fit validation, it states "qualitatively evaluated by a qualified individual," but specific number or detailed qualifications beyond "qualified" are not provided.

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

N/A: No clinical data or AI performance test set requiring adjudication 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:

N/A: This is not an AI-assisted device. No MRMC study was performed. The clinical performance of sequential aligners is stated to be "well established" and "no clinical data is included in this submission."

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

N/A: This is not an algorithm. The Nemocast software (K193003) is mentioned as a tool for planning cases, but the approval is for the aligners themselves, not the software's performance as a standalone diagnostic or treatment algorithm.

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

N/A (for AI context): For the physical device, "ground truth" for manufacturing and fit would be based on engineering specifications and qualitative assessment of fit by a "qualified individual." Biocompatibility is assessed against published international standards.

8. The sample size for the training set:

N/A: There is no AI training set for this device approval.

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

N/A: There is no AI training set for this device approval.

Summary

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September 20, 2021

Biotech Dental Smilers, SAS % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K212961

Trade/Device Name: Smilers Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: September 15, 2021 Received: September 16, 2021

Dear Prithul Bom:

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.

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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 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 (QS) 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K212961

Device Name SMILERS®

Indications for Use (Describe)

Biotech Dental SMILERS® aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e., all second molars) during orthodontic treatment of malocclusion. SMILERS aligners position teeth by way of continuous gentle force.

Type of Use (Select one or both, as applicable)
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|X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K212961 510(k) Summary Biotech Dental SMILERS® 9/6/2021

ADMINISTRATIVE INFORMATION

Manufacturer Name	Biotech Dental Smilers, SAS305, Allée de Craponne13300 Salon de Provence
Telephone:	+33 04 90 44 60 60
Fax:	+33 04 90 44 60 61
Official Contact:	Delphine Mercier, VP Compliance
Email:	d.mercier@biotech-dental.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name:	SMILERS®
Common Name:	Aligners, sequential
Classification Name:	Orthodontic Plastic Bracket
Classification Regulations:	21 CFR 872.5470
Device Class:	Class II
Product Code:	NXC

Review Panel: Dental Products Panel Reviewing Branch: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1) Dental Devices (DHT1B)

PREDICATE DEVICE INFORMATION

The devices within this submission are the same or highly similar in indications, intended use and design principles to the following predicate device:

510(k)	Predicate Device Name	Company Name
K180346	Byte Aligner System	Straight Smile, LLC

DEVICE DESCRIPTION

Special orthodontic aligner treatment planning software, such as Nemocast (K193003) is used to virtually segment and reposition teeth to their desired position for each stage of treatment.

The technology and overall process is the same as that used by the Predicate device, Byte Aligner System (K180346) and other sequential aligner systems currently being legally-marketed.

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INTENDED USE / INDICATIONS FOR USE

EQUIVALENCE TO MARKETED DEVICE

The table below compares Indications for Use and Technological Characteristics of the Subject device and Predicate devices.

Parameter	Subject Device	Predicate Device	Comparison
	SMILERS®Biotech Dental Smilers, SAS	Byte Aligner SystemStraight Smile, LLCK180346
Regulation #	21 CFR 872.5470	21 CFR 872.5470	Same
Classification Name	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket	Same
Product Code	NXC	NXC	Same
Classification	Class II	Class II	Same
Intended Use/Indications for Use	Biotech Dental SMILERS® aligners are indicated for thealignment of teeth in patients with permanentdentition (i.e., all second molars) during orthodontictreatment of malocclusion. SMILERS® aligners positionteeth by way of continuous gentle force.	The Byte Aligner System is indicated for the treatment oftooth malocclusion in patients with permanent dentition(i.e., all second molars). The Byte Aligner systempositions teeth by way of continuous gentle force.	Highly Similar
Intended Population	Individuals with permanent dentition.	Individuals with permanent dentition.	Same
Mode of action	Orthodontic movement occurs through continuousgentle forces applied to the dentition as each toothfollows the programmed displacement based on adoctor's prescription.	Orthodontic movement occurs through continuousgentle forces applied to the dentition as each toothfollows the programmed displacement based on adoctor's prescription.	Same
Method of use	Each aligner is worn by the patient as determined bythe treating dental practitioner, generally for 2 weeksprior to being replaced by the next aligner in sequence.This is repeated for a duration as prescribed by a DentalProfessional.	Each aligner is worn by the patient as determined by thetreating dental practitioner, generally for 2 weeks priorto being replaced by the next aligner in sequence. This isrepeated for a duration as prescribed by a DentalProfessional.	Same
Material	Thermoplastic polymer (polyethylene terephthalateglycol or PETG)	Thermoplastic polymers (polyethylene terephthalateglycol or PETG)	Same
ApplianceApplication	Removable	Removable	Same
Design	Image: clear aligner	Image: clear aligner	Highly Similar
Biocompatible	Yes	Yes	Same
OTC or Rx	Rx	Rx	Same
Sterile	Non-sterile	Non-sterile	Same

Predicate Device Comparison Table

The wording of the Indications for Use statements differs only in the device name.

TECHNOLOGICAL CHARACTERISTICS

Orthodontic tooth movement occurs through forces applied to the teeth by the appliance as each tooth follows the predetermined displacement based on a dental health professional's prescription. The Subject device mode of action, method of use and intended patient population are the same as the Predicate device and supports a determination of substantial equivalence.

The Subject and Predicate devices are both fabricated of non-sterile, biocompatible thermoplastic PETG material which supports a determination of substantial equivalence.

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NON-CLINICAL PERFORMANCE TESTING

Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners was performed. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces.

A manufacturing validation was performed which demonstrated the dimensional accuracy of the manufacturing process for SMILERS®. Using Nemocast software (K193003), cases were planned and the standard manufacturing process used to produce aligners from the treatment plans. The manufacturing validation evaluated dimensional accuracy of manufacturing aids as well as the final finished device. Additionally, a fit validation was performed where treatment planned and manufactured aligner cases were qualitatively evaluated by a qualified individual to determine if the Subject device performs as intended.

A shelf-life/aging study was performed to assess the impact of time-dependent material degradation within the stated shelf-life of the device.

Biocompatibility evaluation and testing for the aligner material was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". A chemical characterization was performed according to ISO 10993-18:2020.

The following biological tests were performed:

Biological Endpoint	Relevant Standard
Cytotoxicity	ISO 10993-5:2009
Sensitization	ISO 10993-10:2010
Irritation	ISO 10993-10:2010
Endotoxins	ANSI/AAMI ST72:2019

Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above. This non-clinical performance testing demonstrates that the Subject device is suitable for intended use as was also done for the Predicate device.

CLINICAL TESTING

The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. No clinical data is included in this submission.

CONCLUSION

Overall, the Indications for Use statement for the Subject and Predicate devices are highly similar differing only in device name. Overall, the Technological Characteristics of the Subject device are the same or highly similar to the Predicate device with any differences mitigated through non-clinical performance testing.

Regulation Number and Section

§ 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.