The Smylio Nightwear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn at least 9 to 12 hours a day and are to be removed for eating and for cleaning.

Smylio Nightwear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g., dentist or orthodontist). Using the scan, sequential dental models are designed and approved by the treating physician prior to manufacturing.

Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligners are shipped to the treating clinician's office where they are then distributed to the patient in sequential stages. The patients' dental health professional then monitors their treatment of the first aligner to the delivery of the final aligner.

Nightwear Aligners are a sequence of transparent aligners created from a digital orthodontic treatment plan. The Nightwear Aligners are fabricated of a transparent thermoformed polyurethane plastic. Each aligner delivers 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 Nightwear Aligners incorporate 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 text describes the Smylio Nightwear Aligners and its substantial equivalence to a predicate device (iSMILE Aligners K200908). However, it does not contain acceptance criteria or a study designed to explicitly prove the device meets specific performance acceptance criteria in terms of diagnostic accuracy or a quantitative measure of treatment effectiveness with a defined threshold.

Instead, the document focuses on demonstrating substantial equivalence for regulatory clearance based on:

Similarities in Indications for Use: Both devices are indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion.
Similarities in Technological Characteristics: The device description, materials, manufacturing method, and mode of action are compared and found to be "Same" as the predicate device.
Non-clinical performance testing: Durability testing, material property testing (ASTM D638, ASTM D790), and biocompatibility testing (ISO 10993 standards) were performed to ensure the material and manufacturing process are suitable.
Clinical performance testing: An internal clinical study was conducted to demonstrate that tooth alignment may occur with the specified wear time for mild malocclusions. This is a descriptive finding rather than a performance metric against a predefined acceptance criterion.

Therefore, many of the requested items (acceptance criteria table, ground truth establishment, MRMC study, effect size) are not explicitly present or detailed in the provided text because the regulatory submission's goal was substantial equivalence, not necessarily a performance claim against specific quantitative targets.

However, I can extract the information that is present and note where the information is absent according to your request.

Description of Acceptance Criteria and Proving Study (Based on Provided Text)

The provided text focuses on establishing substantial equivalence to a predicate device (iSMILE Aligners, K200908) for regulatory purposes, rather than proving the device meets specific quantitative performance acceptance criteria in terms of treatment efficacy or diagnostic accuracy against a predefined threshold. The "acceptance criteria" can be inferred as successful demonstration of similar indications for use, technological characteristics, and safety and basic functional performance, which collectively support substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (as per text)
Indications for Use: Alignment of permanent teeth during orthodontic treatment of malocclusion.	Smylio Nightwear Aligners: Indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion. Predicate (iSMILE Aligners): Indicated for the alignment of teeth during orthodontic treatment of malocclusion. (Result: Same)
Technological Characteristics: Similar materials, design, manufacturing, and mode of action as predicate.	Smylio Nightwear Aligners: Thermoplastic Polymer, thermoformed, patient-specific, removable, delivers combination of minor forces for tooth movement. Predicate (iSMILE Aligners): Shares these characteristics. (Result: Same for all compared specifications including Regulation Number, Classification Name, Product Code, Classification, OTC or Rx, Material, Material Properties, Biocompatibility, Device Description, Anatomy Location, Size, Manufacturing Method, Patient Removable, Mode of Action.)
Material Properties (Non-clinical): Sufficient tensile strength, elasticity, ductility, chemical resistance, and clarity.	Material property testing performed to investigate elongation, tensile and flexural properties in accordance with ASTM D638 and ASTM D790. Demonstrated sufficient properties.
Manufacturing Process (Non-clinical): Robustness from 3D printing through thermoforming.	Internal manufacturing validation performed; robustness of process demonstrated.
Durability (Non-clinical): Suitable for prescribed period of use in real-world simulation.	Durability testing conducted; ensured suitability.
Biocompatibility (Non-clinical): Meets established standards for patient-contacting material.	Biocompatibility testing for aligner material performed in accordance with ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017.
Clinical Performance: Tooth alignment may occur under specified conditions (for mild malocclusions).	Study demonstrated that tooth alignment may occur for patients with at least 9 to 12 hours of wear time per day for one week prior to moving to the next aligner for patients with mild malocclusions.

2. Sample size used for the test set and the data provenance

Sample Size (Clinical): 20 patients
Data Provenance: The study was conducted internally under an FDA cleared IDE application (G200298). The country of origin is not specified but it is an internal clinical performance test. The study is prospective in nature as it is a "clinical performance testing" that "was conducted".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: The clinical performance was determined "as determined by the treating dentist." No further specific qualifications (e.g., years of experience, specialization) are provided for these dentists.

4. Adjudication method for the test set

Adjudication Method: Not specified. The outcome was "as determined by the treating dentist," implying a single determination, not a consensus or adjudicated process among multiple experts.

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

MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is an orthodontic aligner, not an AI-powered diagnostic tool, so such a study would not be applicable. The text does not mention AI assistance.

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

Standalone Performance: Not applicable. This device is a physical orthodontic aligner, not an algorithm or AI system.

7. The type of ground truth used

Type of Ground Truth: The "ground truth" for the clinical performance was the observation that "tooth alignment may occur for patients with mild malocclusions as determined by the treating dentist." This appears to be a clinical assessment/outcome, not pathology, imaging, or universally accepted objective ground truth.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This refers to a physical medical device, not a machine learning algorithm that requires a training set. The "design" (digital models) is approved by the treating physician, but this is not a training set in the context of AI.

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

Ground Truth for Training Set: Not applicable (as above, no training set for an algorithm). The device design process involves digital scans and sequential dental models designed and approved by the treating physician, which would be the "input" for manufacturing, not a training set with established ground truth for an algorithm.

Summary

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April 5, 2023

Smylio Inc. % Jennifer Day Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043

Re: K221537

Trade/Device Name: Nightwear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 26, 2022 Received: May 27, 2022

Dear Jennifer Day:

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 -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) K221537

Device Name Nightwear Aligners

Indications for Use (Describe)

Nightwear Aligners are indicated for the alignment of permanent 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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Attachment A: 510(k) Summary

510(k) SUMMARY

A summary of 510(k) safety and effectiveness information for this submission in accordance with the requirements of 21 CFR 807.92.

Submitter:	Smylio Inc.48890 Milmont DrSuite 101DFremont CA, 94538
Company Contact Person:	Ren Menon, CEO
Phone:	510-868-2184
Email:	rmenon@orthofx.com
Submission Correspondent:	Jennifer Day, Regulatory Affairs ConsultantBreanne Butler, PhD
Company:	Prime Path Medtech Inc.
Address:	1321 Upland Dr, Ste 6792 Houston, TX 77043
Phone:	860-810-5594
Email:	jday@primepathmedtech.com
Date Prepared:	May 26, 2022
Proprietary Name:	Smylio Nightwear Aligners
Common Name:	Orthodontic plastic bracket.
Product Code:	NXC – Orthodontic plastic bracket.
Device Classification:	Class II, 21 CFR 872.5470
Primary Predicate Device:	iSMILE Aligners (K200908)
Reference Predicates:	Smylio Invisible Clear Aligners (K212660)Smylio Invisible Clear Aligners (K172784)

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Device Description:

Indications for Use:

Nightwear Aligners are indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion.

Comparison to Predicate Devices:

Smylio Nightwear Aligners are functionally equivalent to the following predicate device: iSMILE Aligners (K200908). The following table demonstrates the functional specifications of Smylio Nightwear Aligners are substantially equivalent to the predicate devices.

Specification	Subject Device: SmylioNightwear Aligners	Predicate Device: iSMILEAligners (K200908)	ComparisonResult
RegulationNumber	21 CFR 872.5470	21 CFR 872.5470	Same
ClassificationName	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket	Same
Product Code	NXC	NXC	Same
Classification	Class II	Class II	Same

Table 1. Predicate Device Comparison Table

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Specification	Subject Device: SmylioNightwear Aligners	Predicate Device: iSMILEAligners (K200908)	ComparisonResult
OTC or Rx	Rx	Rx	Same
Material	Thermoplastic Polymer	Thermoplastic Polymer	Same
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.	Same
Biocompatible	Yes	Yes	Same
Specification	Subject Device: SmylioNightwear Aligners	Predicate Device: iSMILEAligners (K200908)	ComparisonResult
DeviceDescription	Nightwear Aligners are asequence of transparentaligners created from adigital orthodontic treatmentplan. The Nightwear Alignersare fabricated of atransparent thermoformedpolyurethane plastic. Eachaligner delivers a uniquecombination of minor forcesto create the planned toothmovement. The digitalorthodontic treatment planis created by a dental healthprofessional.The Nightwear Alignersincorporate the use ofattachments to create spacesand force points in order tocause minor toothmovement. These forcepoints are located in specificareas and positioned in sucha way that they provide acontinuous force whichslowly dissipates over timeon the tooth to be moved foras long as the aligner is worn.	The iSMILE is a sequence oftransparent aligners createdfrom a digital orthodontictreatment plan. The iSMILEaligner is fabricated of atransparent thermoformedpolyurethane plastic. Eachaligner delivers a uniquecombination of minor forcesto create the planned toothmovement. The digitalorthodontic treatment planis created by a dental healthprofessional.The iSMILE Alignerincorporates the use ofattachments to create spacesand force points in order tocause minor toothmovement. These forcepoints are located in specificareas and positioned in sucha way that they provide acontinuous force whichslowly dissipates over timeon the tooth to be moved foras long as the aligner is worn.	Same
AnatomyLocation	Mouth; mucosal	Mouth; mucosal	Same
Size	Patient Specific	Patient Specific	Same
Specification	Subject Device: SmylioNightwear Aligners	Predicate Device: iSMILEAligners (K200908)	ComparisonResult
ManufacturingMethod	Thermoforming	Thermoforming	Same
PatientRemovable?	Yes	Yes	Same
Indication forUse	Nightwear Aligners areindicated for the alignmentof permanent teeth duringorthodontic treatment ofmalocclusion.	iSMILE is indicated for thealignment of teeth duringorthodontic treatment ofmalocclusion.	Same
Mode ofAction	Orthodontic toothmovement occurs throughforces applied by theappliance to the dentition aseach tooth follows theprogrammed displacementbased on a doctor'sprescription	Orthodontic toothmovement occurs throughforces applied by theappliance to the dentition aseach tooth follows theprogrammed displacementbased on a doctor'sprescription	Same

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Comparison of Indications for Use to Predicate Devices:

The indications for use of the Smylio Nightwear Aligners are the iSMILE Aligners (K200908) as they are both indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces. Thus, the Smylio Nightwear Aligners can be considered substantially equivalent to its predicate device.

Comparison of Technological Characteristics to Predicate Devices:

Based on the above comparison, the design, construction, and performance characteristics of the Smylio Nightwear Aligners is similar to that of the iSMILE Aligners (K200908). Thus, the Smylio Nightwear Aligners can be considered substantially equivalent to its predicate device.

Non-clinical performance testing:

The use of thermoplastic materials for sequential aligners intended to treat malocclusions has been well documented in scientific literature regarding incremental tooth moving forces.

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However, durability testing was conducted on the Smylio Nightwear Aligners Real world use was simulated to ensure that the aligner material and manufacturing process produced aligners that were suitable for their prescribed period of use.

Material property testing was performed to investigate elongation, tensile and flexural properties of the material in accordance with ASTM D638 and ASTM D790.

An internal manufacturing validation was performed to test the manufacturing process for Smylio Nightwear Aligners. The robustness of the process was demonstrated from 3D printing through thermoforming.

The thermoplastic material used for Smylio Nightwear Aligners is broadly used in many aligners. Biocompatibility testing for the aligner material, the only patient contacting material, was in accordance with the International Standard "Biological evaluation of medical devices" ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-10:2010, and ISO 10993-11:2017.

Clinical performance testing:

Clinical performance testing was conducted on 20 patients for the Smylio Nightwear Aligners under an FDA cleared IDE application (G200298). The study results demonstrated that tooth alignment may occur for patients with at least 9 to 12 hours of wear time per day for one week prior to moving to the next aligner for patients with mild malocclusions as determined by the treating dentist.

Conclusion:

Based on similarities in indications for use, technological characteristics, non-clinical performance testing, and clinical performance testing, Smylio Nightwear Aligners are substantially equivalent to the iSMILE Aligners (K200908).

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.