"Al Smile Aligner" consists of a custom-made series of thin, clear plastic removable orthodontic appliances (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 Nanjing Jiahe Dental Technology Co., Ltd along with the physician's prescription.

An FDA cleared dental software used for teeth alignment was used to design a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription.

Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner travs are then manufactured by thermoforming a dental thermoplastic sheet over each model.

The "Al Smile Aligners" have the same technological characteristics as the predicate device, in that all the devices are made from commercially available plastic that is thermoformed to create a customized, patient-specific aligners are then used for minor tooth movement by way of continuous gentle force.

AI/ML Overview

The provided text is a 510(k) Summary for the "Al Smile Aligner" and primarily focuses on demonstrating substantial equivalence to a predicate device ("iSMILE"). It outlines the device's description, indications for use, and a comparison with the predicate.

However, the document does not contain the information requested about acceptance criteria and a study proving the device meets those criteria (e.g., performance metrics like sensitivity, specificity, or accuracy for an AI-powered diagnostic device). The "Summary of Device Testing" section mentions "nonclinical performance tests" and "Laboratory Testing" (physical, chemical, mechanical properties, process validation, and mechanical property/elasticity according to ASTM standards), but these are related to the physical properties and manufacturing of the aligners, not the performance of an AI component in a diagnostic or treatment planning context as might be expected for an "AI Smile Aligner" if the "AI" referred to a diagnostic algorithm.

Given the context of "Al Smile Aligner" being aligners for orthodontic treatment and the description of the design process involving FDA-cleared dental software, it appears the "AI" in the device name might refer to the software used to design the aligners, rather than an AI performing a diagnostic task. The document specifically states: "An FDA cleared dental software used for teeth alignment was used to design a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription." This implies the AI/software is an internal design tool, and the focus of the 510(k) is on the physical aligner product's substantial equivalence.

Therefore, many of the requested items (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance) are not applicable or not present in this type of 510(k) submission for a physical medical device (orthodontic aligners). The information provided focuses on the physical and material properties, and manufacturing process of the aligners themselves, not the clinical performance of an AI diagnostic or planning algorithm that is directly assisting a human.

Here's a breakdown of the requested information based on the provided text, indicating what is present and what is absent/not applicable:

1. A table of acceptance criteria and the reported device performance

Not present. The document does not describe acceptance criteria for AI performance in terms of diagnostic metrics (e.g., sensitivity, specificity, accuracy). It mentions mechanical and material testing according to ASTM standards and ISO 10993 for biocompatibility, implying those standards serve as "acceptance criteria" for the physical product, but no specific numerical performance is reported in a table format for those tests. The claim is that the device "meets all the requirements" and confirms "design output meets design inputs and specifications."

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/Not present. There is no "test set" described for evaluating AI performance in a clinical context. The tests performed are laboratory tests on the physical aligners.

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)

Not applicable/Not present. No clinical AI evaluation or ground truth establishment is described. The "ground truth" for the aligners is the doctor's prescription and the physical/material specifications.

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

Not applicable/Not present.

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/Not present. This is not an AI diagnostic device for which human reader improvement would be measured. The AI is described as "FDA cleared dental software" used internally for design, not for direct clinical decision support provided to users of the "Al Smile Aligner" product.

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

Not applicable/Not present. As above, the AI is not presented as a standalone diagnostic or clinical decision-making algorithm that the product's 510(k) seeks to clear for direct clinical use. It's a tool in the manufacturing process.

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

Not applicable. The "ground truth" for the physical aligner production seems to be adherence to the dental clinician's prescription and established engineering/biocompatibility standards.

8. The sample size for the training set

Not applicable/Not present. No information about a training set for an AI algorithm is provided.

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

Not applicable/Not present.

Summary of what is covered in the document regarding "device performance":

The document focuses on the substantial equivalence of the physical aligner product to a predicate device. The "Summary of Device Testing" section mentions:

Performance (physical, chemical, mechanical properties): The device "meets all the requirements for overall design... and performance results confirming that the design output meets the design inputs and specifications for the device."
Process Validation: Validate the processes used for the design and manufacture of the customized aligners.
Mechanical Properties & Elasticity: Studied following ASTM standards (ASTM D570, ASTM D638, ASTM D790, and ASTM D1525).
Biocompatibility: Tested according to Good Laboratory Practices and ISO 10993 (Parts 3, 5, 10, 11). The device "Meet ISO 10993-1."
Bench Testing and Process Validation: "Bench Testing and Process Validation" is listed in the comparison table as part of performance and is stated to be met by both the subject and predicate devices.

The "AI" in "Al Smile Aligner" refers to the software used for the design of the aligners, which is described as "An FDA cleared dental software used for teeth alignment." The 510(k) is for the physical aligner product itself, not for the "AI" software as a separate, new clinical decision support or diagnostic device. As such, the performance evaluation is centered on the physical attributes and manufacturing processes of the aligners, not on the clinical performance of an AI algorithm in a test set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 20, 2022

Nanjing Jiahe Dental Technology Co., Ltd. % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland. New Jersey 07436

Re: K222308

Trade/Device Name: Al Smile Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 22, 2022 Received: November 22, 2022

Dear Charles Shen:

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 medical devices and radiation-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).

Sincerelv.

Michael E. Adjodha -S

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) K222308

Device Name Al Smile Aligner

Indications for Use (Describe)

"Al Smile Aligner" is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K22308

Section 5: 510(k) Summary:

This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92

Submitter & Foreign Manufacture Identification 5.1

Nanjing Jiahe Dental Technology Co., Ltd. Room 201, Building 2, No.2 Shuanglong Street, Oinhuai District, Naujing, Jiangsu Province, China, Zipcode 210000 Tel: (086) 400-0880468 Submitter's FDA Registration Number: N/A

Contact Person 5.2

Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com

Date of Summary: July 11, 2022 5.3

5.4Device Name:
Proprietary Name:	Al Smile Aligner
Common Name:	Dental Plastic Aligner
Classification Name:	Orthodontic Plastic Brackets - Sequential Aligners
Device Classification:	II
Regulation Number:	21 CFR 872.5470
Panel:	Dental
Product Code:	NXC

ર્સ્ટ Predicate Device Information:

K200908, "iSMILE", manufactured by "3D Diagnostix Inc." (1)

ર્સ્વ Device Description:

"Al Smile Aligner" consists of a custom-made series of thin, clear plastic removable orthodontic appliances (aligners) that apply gentle pressure to teeth, gradually moving them into alignment.

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An FDA cleared dental software used for teeth alignment was used to design a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription.

5.7 Indications for Use:

"Al Smile Aligner" is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

ર્સ્ક Summary of Device Testing:

As part of demonstrating substantial equivalence of "Al Smaile Aligner" to the predicate device that are subject to this 510(k) submission, we have completed a number of nonclinical performance tests. "Al Smile Aligner" meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device.

Laboratory Testing

Performance including physical, chemical, and mechanical properties ●
. Validate the processes used for the design and manufacture of the customized aligners.
Additionally, mechanical property and elasticity of the thermoformed device were ● studied following ASTM standards such as ASTM D570, ASTM D638, ASTM D790, and ASTM D1525.

Biocompatibility Testing

The device has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows:

Part 3 (Ames Assay) ●
Part 5 (Cytotoxicity) ●
Part 10 (Oral Mucosa Irritation)
Part 10 (Maximization for Delayed-Type Hypersensitivity) ●
Part 11 (Systemic Toxicity) ●

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5.9 Technological Comparison with Predicate Device

The following table shows similarities and differences of use, design, and material between our device and the predicate devices.

Description	Subject Device	Predicate Device (K200908)	SEDecision
Brand Name	Al Smile Aligner	iSMILE	SE
RegulationNumber	21 CFR 872.5470	21 CFR 872.5470	SE
Product Code	NXC	NXC	SE
Classification	Class 2	Class 2	SE
Indication forUse	"Al Smile Aligner" is indicated for thealignment of teeth during orthodontictreatment of malocclusion.	iSMILE is indicated for thealignment of teeth duringorthodontic treatment ofmalocclusion.	SE
Mode of Action	Alignment of teeth by application ofcontinuous gentle force, by sequentialuse of preformed plastic trays,fabricated based on doctor'sprescription.	Alignment of teeth by applicationof continuous gentle force, bysequential use of preformedplastic trays, fabricated based ondoctor's prescription.	SE
Materials	Thermoplastic	Thermoplastic	SE
Processing	Thermoforming	Thermoforming	SE
Dimension	Customized patient specific	Customized patient specific	SE
AnatomyLocation	Dental mucosal	Dental mucosal	SE
Single Use	Yes	Yes	SE
Prescription orOTC	Rx	Rx	SE
Sterile	Non-sterile	Non-sterile	SE
Software Use	Yes	Yes	SE
Product Picture	Image: Product Picture	Image: Product Picture	SE
Biocompatibility
Performance	Meet ISO 10993-1	Meet ISO 10993-1	SE
	Bench Testing and Process Validation	Bench Testing and Process Validation	SE

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Our device is essentially identical to the predicate device in terms of indications for use, design, material, and processing between our device and the predicate devices.

5.10 Substantial Equivalence Conclusion

It has been shown in this 510(k) submission that "Al Smile Aligner" and its predicate devices have the identical indications for use, similar composition and biocompatibility, similar manufacturing process, and adequate performance.

The difference between the "Al Smile Aligner" and their predicate device do not raise any question regarding its equivalence.

"Al Smile Aligner", as designed and manufactured, is equivalent to its predicate device, and therefore is substantially equivalent as its predicate device.

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.