The patient specific set of Clear Dental Aligners are indicated for the treatment of tooth malocclusion in patients having permanent dentition. These Aligners position teeth by way of continuous gentle force. These are for self-use by patient with monitoring of improvement by orthodontists.

Device Description

The Clear Dental Aligners are thermoformed, orthodontic wearable & removable dental appliances that, when worn in the prescribed sequence and duration, progressively reposition the permanent malocclusion teeth. These aligners could be soft, medium, or hard as per prescription set by an orthodontist, and to exert the desired & continuous gentle force to progressively position the teeth. Each aligner is made of thermoforming BPA free material sheets.

AI/ML Overview

The provided text, K223338, details the 510(k) premarket notification for the "Toothsi&SmileAligners" device. The document primarily focuses on demonstrating substantial equivalence to a predicate device ("ClearCorrect System, K113618") through comparison of specifications and bench testing.

Based on the provided text, there is no acceptance criteria or study that proves device performance against specific metrics relevant to AI/algorithm-driven medical devices (e.g., sensitivity, specificity, accuracy). The document outlines acceptance criteria and performance for non-clinical bench testing related to the physical properties and manufacturing of the aligners, not for an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about AI-specific studies (sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) because the provided FDA submission document pertains to a physical medical device (orthodontic aligners) and not a software/AI-driven device requiring such performance metrics.

The "K223338" submission is for "Orthodontic Plastic Bracket" (Product Code NXC), which is a physical device that repositions teeth using continuous gentle force. The performance testing outlined (Table 2 on page 5) is for the physical aligners' properties:

Surface finishing after polishing by two methods: Accepted
Thickness of aligners after thermoforming with reference to aligner sheets: Accepted
Aligner shape accuracy after mimicked use for 15 days: Accepted
3D Model shape accuracy for effectiveness of aligner punching as per treatment plan: Accepted

These are all physical engineering characteristic tests, not performance metrics for an AI or algorithm. The document explicitly states: "No comparative testing with predicate device was possible since clear dental aligners are patient specific devices made after treatment plan." and "The above four tests relate to safety (Sr. No 1 & 4) and performance (Sr. No 2, 3 and 4) of the clear aligners."

In summary, the provided document does not contain the information required to answer questions about acceptance criteria and study data for an AI/algorithm-driven device, as the submission is for a physical medical device.

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 and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 9, 2023

AMPA Orthodontics Private Limited % Sanjeev Gupta Managing Consultant Intrust A301/A Green Heritage, Plot 79-80, Sector 20 Kharghar, Maharashtra 410210 India

Re: K223338

Trade/Device Name: Toothsi&SmileAligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC. Dated: October 29, 2022 Received: November 1, 2022

Dear Sanjeev Gupta:

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

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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,

Bobak Shirmohammadi -S

For Michael Adjodha, M.ChE.,CQIA 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

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Indications for Use

510(k) Number (if known) K223338

Device Name Toothsi&SmileAligners

Indications for Use (Describe)

The patient specific set of Clear Dental Aligners are indicated for the treatment of tooth malocclusion in patients having permanent dentition. These Aligners position teeth by way of continuous gentle force. These by patient with monitoring of improvement by orthodontists.

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)

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Image /page/3/Picture/0 description: The image shows the word "toothsi" in a red, sans-serif font. A curved line is below the "t" in "toothsi", resembling a smile. A four-pointed star is above the "i" in "toothsi".

510 k Summary - Substantial Equivalence Discussion K223338

A. Name and Address of:Manufacturer	AMPA Orthodontics Private Limited1st Floor, Empire Plaza B WingLal Bahadur Shastri MargVikhroli WestMumbai 400083Maharashtra, IndiaPhone/Fax: +91 9820340245Contact Person: Dr. Manjul Jain (drmanjul@toothsi.in)
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B. Device Details:

a) Trade Name: Toothsi & SmileAligners
b) Common Name: Clear Dental Aligners
c) Classification Name: Aligner, Sequential
d) Product Code: NXC
C. Predicate Device: ClearCorrect System (K113618)
D. Device Description: The Clear Dental Aligners are thermoformed, orthodontic wearable & removable dental appliances that, when worn in the prescribed sequence and duration, progressively reposition the permanent malocclusion teeth. These aligners could be soft, medium, or hard as per prescription set by an orthodontist, and to exert the desired & continuous gentle force to progressively position the teeth. Each aligner is made of thermoforming BPA free material sheets.
E. Intended Use The patient specific set of Clear Dental Aligners are indicated for the treatment of tooth malocclusion in patients having permanent dentition. These Aligners position teeth by way of continuous gentle force. These are for self-use by patient with monitoring of improvement by orthodontists.

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+91 98980000000

1st floor, Empire Plaza B Wing, Lal Bahadur Shashtri Marg, Vikhroli (West), Mumbai - 400083

Info@toothsi.in X 0 www.toothsi.in

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Image /page/4/Picture/0 description: The image shows the word "toothsi" in red font. The "t" in toothsi is lowercase, and the two "o"s are connected. There is a curved line under the first "t" that resembles a smile. There is a four-pointed star to the right of the "i".

F: Comparison of proposed device with predicate device for

EquivalencePoints	Clear Dental Aligners	ClearCorrect System(K113618)	Comparison
Manufacturer	AMPA Orthodontics Pvt. Ltd.	CLEARCORRECT LLC	N/A
Product Code	NXC	NXC	Equivalent
RegulationNumber	21 CFR 872.5470	21 CFR 872.5470	Equivalent
IntendedUse/Indicationsfor Use	The patient specific set of ClearDental Aligners are indicated forthe treatment of toothmalocclusion in patients havingpermanent dentition.TheseAligners position teeth by way ofcontinuous gentle force. These arefor self-use by patient withmonitoring of improvement byorthodontists.	The ClearCorrect System isindicated for the treatment oftooth malocclusion in patientswith permanent dentition (i.e.all second molars).The ClearCorrect Systempositions teeth by way ofcontinuous gentle force	Equivalent
Mechanism ofAction	Continuous gentle force tomove the teeth	Continuous gentle force tomove the teeth	Equivalent
Material ofConstruction	Thermoplastic	Thermoplastic	Equivalent
Aligner MaterialThickness(For differentaligner set)	~0.5 mm to ~1.0 mm as pertreatment plan	Soft (0.5 mm)	Equivalent
		Medium (0.62 mm)
		Hard (0.75 mm)Ultra Hard (1 mm)
Biocompatible	Complies with ISO 10993 (FR# 2-248 & 2-296)	ISO 10993-1	Equivalent
PrescriptionSteps	Approximately 7-14 days/alignerset as per prescription	Soft (1 Week)	Equivalent
		Medium (1 Week)
		Hard (1 Week)
Daily Duration ofwear	At least 20-22 hours	17 hours a day	Equivalent
Sterile	Non-Sterile	Non-Sterile	Equivalent
Single-Use	Single User Use	Single User Use	Equivalent

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1* floor, Empire Plaza B Wing, Lal Bahadur Shashtri Marg, Vikhroli (West), Mumbai - 400083

+91 98980000000
K

Info@toothsi.in

www.toothsi.in

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Image /page/5/Picture/0 description: The image shows the word "toothsi" in red font. The "t" in toothsi is stylized with a curved line underneath, resembling a smile. There is a four-pointed star to the right of the "i" in toothsi. The font is rounded and sans-serif.

G. Performance Testing Bench (Non-clinical)

The following bench testing was performed as part of Design Verification with purpose define in column 2 of Table 2 below. The reports are presented in sequence along with data tables and figures as applicable in 018_Performance Testing Bench. No separate annexure has been created for this section.

Table 2: Summary of bench testing performed on design samples of clear dentalaligners			Test Outcome
Sr.No	Purpose of Bench Testing	Report Number
1	Surface finishing after polishing by twomethods	Report No. AO/DV/R1dated 31-12-2021	Accepted
2	Thickness of aligners after thermoformingwith reference to aligner sheets	Report No.: AO/DV/R2Dated 31-12-2021	Accepted
3	Aligner shape accuracy after mimicked usefor 15 days	Report No.: AO/DV/R7Dated 10-01-2022	Accepted
4	3D Model shape accuracy for effectivenessof aligner punching as per treatment plan	Report No.: AO/DV/R3Dated 10-01-2022	Accepted

The above four tests relate to safety (Sr. No 1 & 4) and performance (Sr. No 2, 3 and 4) of the clear aligners. No comparative testing with predicate device was possible since clear dental aligners are patient specific devices made after treatment plan.

H. Substantial Equivalence Discussion

Comparison of specifications with predicate device: The Section F-Table 1 above summarizes the comparison of subject device with predicate device.

a) Similarities: As it emerges from the review of Section F-Table 1 the characteristics related to Intended Use, Mechanism of Action, Material Thickness, Material of Construction, Prescription Steps are equivalent between predicate and subject devices.
b) Differences: The duration of wearing aligner is around 17 hours in predicate device and around 22 hours for subject device. This difference is subjective and does not alter safety and performance of the devices. Such difference majorly emerges from the user actions.

Ver 01 Date 2022-12-20

+91 98980000000

Info@toothsi.in

1st floor, Empire Plaza B Wing, Lal Bahadur Shashtri Marg, Vikhroli (West), Mumbai - 400083

0 www.toothsi.in

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Image /page/6/Picture/0 description: The image shows the word "toothsi" in red font. The "tooth" part of the word is above a curved line, also in red, that resembles a smile. To the right of the "i" is a red star.

c) Standards Testing: AMPA Orthodontics Private Limited has performed biocompatibility testing of the subject device by application of ISO 10993 standards which has also been followed by the predicate device manufacturer.
Conclusions: We, therefore, conclude that Clear Dental Aligner manufactured by AMPA Orthodontics Private Limited have substantial equivalence with ClearCorrect Aligners (K113618) Manufactured by ClearCorrect LLC.

Ver 01 Date 2022-12-20

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1st floor, Empire Plaza B Wing, Lal Bahadur Shashtri Marg, Vikhroli (West), Mumbai - 400083

+91 98980000000 Info@toothsi.in

www.toothsi.in

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.