The Ensmile is a sequence of transparent aligners created from a digital orthodontic treatment plan. The Ensmile aligner is fabricated of a transparent thermoformed polyurethane plastic. Each aligner delivery a unique combination of minor forces to create the planned tooth movement. The digital orthodontic treatment plan is created by a dental health professional. The Ensmile Aligner incorporates the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn.

AI/ML Overview

The provided document is a 510(k) summary for the Ensmile Dental Plastic Aligners. It describes the device, its intended use, and its substantial equivalence to a predicate device (Invisalign System, K081960).

However, the document does not contain specific information regarding acceptance criteria for a performance study with numerical results, nor does it detail a study that proves the device meets such criteria in the way requested in the prompt.

The "Performance Data" section states that "Ensmile passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device." and lists:

Biocompatibility testing per ISO 10993-1.
Process Flow validation was performed to ensure that the finished device matches the software output specifications. "The output and work model and aligner were tested and compared. Aligners met the specifications of this testing."

It also mentions that "There are no differences between Ensmile and Invisalign System was defined therefore a performance testing was performed to Ensmile to ensure that patients are receiving the aligners as prescribed by the practitioner to move their teeth as intended (final position). The results of this performance testing are accepted according to acceptance criteria and do not raise any additional concerns."

Based on the provided text, I cannot fulfill the request to describe the acceptance criteria and a study that proves the device meets the acceptance criteria with the level of detail requested, as that information is not present in the document. The document primarily focuses on establishing substantial equivalence through comparison of technological characteristics, materials, and mode of action, and high-level statements about passing tests.

Therefore, for each point requested:

A table of acceptance criteria and the reported device performance: This information is not provided in a table format with specific metrics. The document only generically states that the aligners "met the specifications of this testing" for process flow validation and "passed" biocompatibility.
Sample sizes used for the test set and the data provenance: No sample sizes are provided for any performance testing, nor is the data provenance (e.g., country of origin, retrospective/prospective) mentioned for the "Process Flow validation" which is the closest thing to performance testing mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a clinical or performance study involving human experts for ground truth establishment.
Adjudication method for the test set: Not applicable, as no such test set or adjudication process is described.
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. This device is a physical aligner, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "software output specifications" and "Process Flow validation," implying the software's role in creating the aligner design. However, no specific "standalone" performance metrics of the algorithm itself are provided. The "performance testing" mentioned seems to be related to the physical product meeting design specifications rather than the software's interpretive abilities.
The type of ground truth used: For the "Process Flow validation," the ground truth seems to be the "software output specifications" and the "work model." It's about manufacturing accuracy against a digital plan, not a clinical ground truth like pathology or outcomes data.
The sample size for the training set: Not applicable, as there's no mention of an AI model being trained, or a training set being used in the context of device performance. The software mentioned is for design, not for data-driven diagnostic or predictive tasks in the way "training set" usually implies for AI devices.
How the ground truth for the training set was established: Not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 16, 2023

Ensmile Pvt Ltd Mirza Rehman Head of Firm Main Canal RD, No. 2 Block H Johar Town, Lahore 54000 PAKISTAN

Re: K222619

Trade/Device Name: Ensmile Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: February 13, 2023 Received: February 13, 2023

Dear Mirza Rehman:

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,

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222619

Device Name Ensmile

Indications for Use (Describe)

Ensmile Dental Plastic Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

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 contains the logo for "ensmile Invisible Dental Aligners". The logo features the word "ensmile" in a bold, blue sans-serif font. Below "ensmile" is the text "Invisible Dental Aligners" in a smaller, lighter blue font. Above the word "ensmile" are two curved, yellow lines that resemble a smile.

510(k) Summary

510(k) SUMMARY Ensmile Pvt Ltd's Ensmile 510K Number: K222619

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

COMPANY'S NAME AND ADDRESS

Ensmile Pvt Ltd Main Canal RD, No. 2 Block H Johar Town Lahore Pakistan 54000

Phone: +92 42 111 321 111

Contact Person: Mirza Gohar Rehman Date Prepared: March 16, 2023

Name of Device and Name/Address of Sponsor

Name of Device:	Ensmile
Common or Usual Name:	Dental Plastic Aligners
Classification Name:	Orthodontic Plastic Brackets - Sequential Aligners (21 CFR 892.5470)
Regulatory Class:	II
Product Code:	NXC

Primary Predicate Devices

Invisalign System	K081960
Align Technology, Inc.

Intended Use / Indications for Use

The Ensmile is intended to be used for the alignment of teeth during orthodontic treatment of malocclusion.

The Ensmile is indicated for use in alignment of teeth during orthodontic treatment of malocclusion.

Technological Characteristics

The Ensmile Aligners that are produced have the same technological characteristics as the primary 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.

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Image /page/4/Picture/0 description: The image shows the logo for Ensmile Invisible Dental Aligners. The logo features two curved yellow lines above the word "ensmile" in blue. Below "ensmile" is the text "Invisible Dental Aligners" in a smaller blue font. The logo is simple and modern, with a focus on the brand name and product.

Ensmile Pvt Ltd

510(k) Summary

In both devices, the aligners are created by thermoforming commercially available plastic material. The Ensmile Aligners are thermoformed by Ensmile Pvt Ltd and in the case of the primary predicate device; the aligners are thermoformed by an outside laboratory.

The Ensmile Aligner incorporates the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn.

Performance Data

As part of demonstrating safety and effectiveness of Ensmile and in showing substantial equivalence to the primary predicate device that are subject to this 510(k) submission, Ensmile Pvt Ltd completed a number of non-clinical performance tests. Ensmile 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.

Ensmile passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

Biocompatibility testing per ISO 10993-1 passed cytotoxicity, sensitization, irritation, Acute Systemic Toxicity, Mutagenicity, and Subacute Toxicity for the used thermoforming sheets.
Process Flow validation was performed to ensure that the finished device matches the software output specifications. The output and work model and aligner were tested and compared. Aligners met the specifications of this testing.

In all instances, the Ensmile functioned and Biocompatibility Testing, and Process Flow Validation observed was as expected.

Feature	Proposed DeviceEnsmile	Primary Predicate DeviceInvisalign System
K Number	K222619	K081960
Manufacturer	Ensmile Pvt Ltd	Align Technology, Inc.
RegulationNumber	21 CFR 872.5470	21 CFR 872.5470
DeviceClassificationName	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket
Product Code	NXC	NXC
Device Class	Class II	Class II
Indications forUse	Ensmile is indicated for the alignmentof teeth during orthodontic treatmentof malocclusion.	The Invisalign System is indicated forthe alignment of teeth duringorthodontic treatment of malocclusion.
Feature	Proposed Device	Primary Predicate Device
K Number	EnsmileK222619	Invisalign SystemK081960
Device Description	The Ensmile is a sequence oftransparent aligners created from adigital orthodontic treatment plan.The Ensmile aligner is fabricated of atransparent thermoformedpolyurethane plastic. Each alignerdelivery a unique combination of minorforces to create the planned toothmovement.The digital orthodontic treatment planis created by a dental healthprofessional.The Ensmile Aligner incorporates theuse of attachments to create spacesand force points in order to causeminor tooth movement. These forcepoints are located in specific areas andpositioned in such a way that theyprovide a continuous force whichslowly dissipates over time on the toothto be moved for as long as the aligner isworn.	The current Invisalign system is a seriesof clear plastic aligners that are used toreplace traditional orthodontic wiresand brackets for the alignment ofmaloccluded or misaligned teeth.This series of aligners moves the teethgently, and in small increments, fromtheir original to their final treatedposition for improved dentalalignment.
Mode ofAction	Orthodontic toothmovement occurs throughforces applied by theappliance to the dentitionas each tooth follows theprogrammed displacementbased on a doctor'sprescription	Orthodontic toothmovement occurs throughforces applied by theappliance to the dentitionas each tooth follows theprogrammed displacementbased on a doctor'sprescription
Anatomy Location	Mouth; mucosal	Mouth; mucosal
Size	Patient specific	Patient specific
ManufacturingMethod	Thermoforming	Thermoforming
Material	Thermoplastic Polymer	Thermoplastic Polymer
MaterialProperties	Demonstrates sufficienttensile strength, elasticity,ductility, chemical resistance,and clarity for use as a cleartray aligner.	Demonstrates sufficienttensile strength, elasticity,ductility, chemical resistance,and clarity for use as a cleartray aligner.
Software Used	Yes	Yes
Feature	Proposed DeviceEnsmile	Primary Predicate DeviceInvisalign System
K Number	K222619	K081960
Workflow
Design	Image: Ensmile aligner	Image: Invisalign aligner

Substantial Equivalence

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Image /page/5/Picture/0 description: The image contains the logo for "ensmile Invisible Dental Aligners". The logo features two curved yellow lines above the word "ensmile", which is written in blue. Below "ensmile" is the text "Invisible Dental Aligners", also in blue.

Ensmile Pvt Ltd

510(k) Summary

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Image /page/6/Picture/0 description: The image contains the logo for "ensmile Invisible Dental Aligners". The logo features two curved yellow lines above the word "ensmile", which is written in blue. Below "ensmile" is the text "Invisible Dental Aligners", also in blue.

Ensmile Pvt Ltd

510(k) Summary

Ensmile has the same intended uses and similar indications, technological characteristics, Manufacturing Method, Material Used and principles of operation as its primary predicate device. Ensmile is substantial equivalent to the Invisalign System.

There are no differences between Ensmile and Invisalign System was defined therefore a performance testing was performed to Ensmile to ensure that patients are receiving the aligners as prescribed by the practitioner to move their teeth as intended (final position). The results of this performance testing are accepted according to acceptance criteria and do not raise any additional concerns.

Conclusions

Ensmile Aligners moves teeth by way of continuous gentle force through a sequence of clear aligners that follow the treatment plan developed by the clinician as does the primary predicate device, Invisalign System.

The conclusions drawn from the data included in this submission, demonstrates that the Ensmile Aligner is substantially equivalent to the primary predicate devices cleared under premarket notification K081960 (Primary Predicate Device) in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.

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.