The DailyMate Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.

Device Description

The DailyMate® Orthodontic Aligner System is a series of dental aligners fabricated of clear, plastic removable aligners are designed and custom-made by dental professionals. The aligners are made of aesthetic and medical grade materials. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them, specifically for the DailyMate Orthodontic Aligner System (K212803).

Based on the document, it's clear this is a premarket notification (510(k)) submission for an orthodontic aligner system. The review focuses on substantial equivalence to predicate devices rather than proving specific device performance criteria through clinical studies or AI algorithm validation in the way one might for a diagnostic AI device.

Therefore, the requested information about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in terms of performance metrics for an AI algorithm is largely not applicable in the context of this 510(k) submission. This document describes a medical device, but not an AI/ML powered device that would have the specific types of performance studies (e.g., MRMC, standalone algorithm performance, ground truth establishment by experts) commonly associated with AI/ML medical devices.

The acceptance criteria here are for demonstrating substantial equivalence primarily through comparison of design, materials, indications for use, and a limited set of non-clinical (bench) tests.

Despite the non-applicability to AI/ML device validation, I will extract and present the relevant information that is available in the document, framed within the lens of substantial equivalence.

Overview of "Acceptance Criteria" for K212803 (DailyMate Orthodontic Aligner System)

The "acceptance criteria" for this 510(k) submission are not defined as specific performance metrics of an AI algorithm, but rather as meeting the requirements for substantial equivalence to predicate devices. This is achieved by demonstrating comparable:

Indications for Use
Mechanism of Action
Method of Use
Method of Manufacture
Raw Material (Biocompatibility)
Software Use (for aligner design)
Sterilization (or lack thereof)
And performing specific non-clinical (bench) tests to show material equivalence.

The "study that proves the device meets the acceptance criteria" refers to the entire 510(k) submission package, which includes a comparative analysis table and results from non-clinical bench testing.

Details as per the requested format:

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

Criteria Area (for Substantial Equivalence)	Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance / Comparison
Indications for Use	Substantially equivalent to predicate device (K182329) and reference device (K143630).	DailyMate: "treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force."Predicate (SureCure): Same wording.Reference (Invisalign): "alignment of teeth during orthodontic treatment of malocclusion." Conclusion: "Same as the predicate device" for SureCure. (Slight difference with Invisalign's wording, but considered equivalent for treatment purpose).
Mechanism of Action	Substantially equivalent.	DailyMate: "Based on the clinician's treatment plan, each aligner is used for a defined period of time to exert gentle force to achieve progressive realignment of the teeth. This occurs over time until the final correction has been achieved."Predicate (SureCure): Same wording.Reference (Invisalign): "Sequential aligners apply continuous gentle force to the teeth." Conclusion: "Same." (For SureCure).
Method of Use	Substantially equivalent.	DailyMate: "Each preformed plastic tray is worn by the patient as prescribed by the dental practitioner, usually a few weeks prior to using the next sequential aligner tray."Predicate (SureCure): Same wording.Reference (Invisalign): "Aligners are worn for approximately 2 weeks of 20-22 hours of wear per day, after which it is replaced by the next stage aligners." Conclusion: "Same as the predicate device." (For SureCure).
Method of Manufacture	Substantially equivalent.	DailyMate: "Using software, molds/models are 3D printed based on the treatment plan. Aligners are fabricated on the molds using a thermoforming machine."Predicate (SureCure): Same wording.Reference (Invisalign): Uses 3-D software, scans, generates images of final/intermediate states, practitioner approval, then fabrication. Conclusion: "Same as the predicate device." (For SureCure).
Raw Material Used	Substantially equivalent/similar.	DailyMate: "Thin thermoformed polyurethane."Predicate (SureCure): "Thin thermoformed polyurethane."Reference (Invisalign): "Thin thermoformed polyurethane." Conclusion: "Similar."
Biocompatibility	Materials must be biocompatible for intended use (mucosal membrane contact > 30 days). Tested per ISO 10993 Parts 5 (Cytotoxicity) and 10 (Sensitization, Oral Mucosa Irritation).	Results: "The testing results demonstrate that the material of DailyMate® Orthodontic Aligner System is biocompatible for the intended use."
Non-Clinical Bench Testing (Material)	Demonstrates equivalence in material properties. Tests included pH change, water absorption change, and tensile strength change.	Comparison: Bench tests comparing DailyMate® Orthodontic Aligner System and Invisalign System showed "substantial equivalent" results for pH change, water absorption change, and tensile strength change.
Software Use	Utilizes 510(k) cleared dental software for aligner design and review, similar to predicate.	DailyMate: Uses "3Shape Ortho System" (K152086).Predicate (SureCure): Uses "3Shape Ortho System".Reference (Invisalign): Uses "Invisalign System 3-D software." Conclusion: "Same as the predicate device." (For SureCure, both use the same cleared software).
Regulatory Class/Code/Rx Status	Match predicate device.	All are Class II, Product Code NXC, Rx Use. Conclusion: Same.
Manufacturing Standards	Adherence to Quality System (QS) regulation / GMP standards (e.g., ISO 13485 certification). Mitigation of risks associated with customized treatment plans.	Reported: Manufacturer is "an ISO13485 certified facility which follows GMP standards during the manufacturing processes." Risks mitigated by using 510(k) regulated software and requiring certified dental practitioner approval for every treatment plan.

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

Test Set Sample Size: Not applicable in the context of an AI/ML test set. The "testing" referred to is biocompatibility testing (material samples) and non-clinical bench testing (device material samples). No human patient "test set" was used for performance evaluation.
Data Provenance: The document does not specify the country of origin for the non-clinical testing data. The biocompatibility and bench testing data would be from laboratory experiments rather than patient data. The manufacturer is 3D Global Biotech Inc. from Taiwan. The correspondent contact is in California, USA.
Retrospective/Prospective: Not applicable, as no clinical study on patient data was performed. The non-clinical tests are prospective laboratory studies.

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

Not applicable. There was no AI/ML test set requiring expert-established ground truth. The "ground truth" equivalent for this device is the established safety and efficacy profiles of the predicate devices and the physical/chemical properties of the materials and device.

4. Adjudication method for the test set

Not applicable. No expert adjudication was relevant or required for this type of submission.

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

No. An MRMC study was not performed, as this is not an AI/ML assistance device for human readers.

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

No. This is not a standalone AI algorithm device. The device itself is the physical aligner system. The software mentioned (3Shape Ortho System) is separate, already 510(k) cleared software used in the design process of the aligners and is human-in-the-loop (dental practitioner reviews and approves).

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

For biocompatibility and material equivalence, the "ground truth" is established laboratory testing standards (e.g., ISO 10993) and the known properties/performance of the predicate device materials. There is no "truth" in the diagnostic sense (like pathology or outcomes data).

8. The sample size for the training set

Not applicable. This device does not involve a training set for an AI/ML algorithm.

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

Not applicable. As there is no AI/ML training set, no ground truth needed to be established for it.

Summary regarding AI/ML related criteria:

The provided document describes a 510(k) submission for a physical medical device (orthodontic aligners). While software (3Shape Ortho System) is used in the design and manufacturing process of the aligners, the submission emphasizes that this software is already 510(k) cleared (K152086) and is used by a human dental practitioner who reviews and approves the treatment plan. Therefore, the DailyMate Orthodontic Aligner System itself is not an AI/ML-powered diagnostic or therapeutic device requiring validation studies typical for AI/ML products (e.g., MRMC, standalone algorithm performance, specialized ground truth establishment). The "acceptance criteria" and "proof" in this context are solely related to demonstrating substantial equivalence to predicate devices through design comparison, material testing, and adherence to manufacturing standards.

Summary

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3D Global Biotech Inc % Diana Lam Regulatory Affairs Specialist 370 W Grand Blvd #110 Corona, California 92882

Re: K212803

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

Dear Diana Lam:

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 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

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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,

For 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) K212803

Device Name DailyMate Orthodontic Aligner System

Indications for Use (Describe)

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 3D Global Biotech. The logo consists of the number "3D" in green on the left, and the words "GLOBAL BIOTECH" in gray on the right. The words "GLOBAL" and "BIOTECH" are stacked on top of each other.

510(k) Summary K212803

Applicant:

3D Global Biotech Inc.

Address: 21F.-3, No.99, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City 221, Taiwan .
Contact: Dr. Keng-Liang Ou, President .
Telephone: +886-2-26971270

Correspondent Contact:

Diana Lam,

370 W. Grand Blvd, Suite 110, Corona, CA 92882

Date Summary Prepared:

May 6th, 2022

DEVICE NAME: DailyMate® Orthodontic Aligner System

TRADE NAME: DailyMate® Orthodontic Aligner System

COMMON NAME: Aligner, Sequential

DEVICE CLASSIFICATION Name: Orthodontic Plastic Bracket

CLASSIFICATION REGULATION NUMBER: 21 CFR 872.5470 DEVICE CLASSIFICATION: CLASS II CLASSIFICATION PRODUCT CODE: NXC

Predicate Device

Primary	SureCure OrthodonticAligner System	K182329	Digital OrthodonticCare
Predicate
ReferenceDevice	Invisalign System	K143630	Align Technology, Inc.
ReferenceDevice	3Shape Ortho SystemTM	K152086	3Shape A/S

Indications for Use

The DailyMate® Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.

Description of Device

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Image /page/4/Picture/0 description: The image shows the logo for Global Biotech. The logo consists of a green stylized "3D" on the left, followed by the words "GLOBAL" and "BIOTECH" stacked on top of each other in gray. The "3D" is a stylized design, with the "3" and "D" connected.

Substantial equivalence

The DailyMate® Orthodontic Aligner System is substantially equivalent to the predicate device and the reference device with respect to indications for use, mechanism of action and materials...... as demonstrated in the comparison table below.

Item Name	Subject device	Predicate Device	Predicate Device	SubstantialequivalenceAnalysis
Device name	DailyMate®OrthodonticAligner System	SureCureOrthodontic AlignerSystem	InvisalignSystem
Manufacturer	3D GlobalBiotech Inc.	Digital OrthodonticCare	AlignTechnology, Inc.
510(K) No.	K212803	K182329	K143630	-
RegulationNo.	21 CFR 872.5470	21 CFR 872.5470	21 CFR 872.5470	Same
ClassificationName	OrthodonticPlastic Bracket	Orthodontic PlasticBracket	OrthodonticPlastic Bracket	Same
RegulatoryClass	Class II	Class II	Class II	Same
Product Code	NXC	NXC	NXC	Same
Indicationsforuse/Intendeduse	The DailyMateOrthodonticAligner System isindicated for thetreatment of toothmalocclusion inpatients withpermanentdentition. Thealigner systemrepositions teethby way ofcontinuous gentleforce.	The SureCureOrthodontic AlignerSystem is indicatedfor the treatment oftooth malocclusionin patients withpermanent dentition.The aligner systemrepositions teeth byway of continuousgentle force.	The InvisalignSystem is indicatedfor the alignment ofteeth duringorthodontictreatment ofmalocclusion	Same as thepredicatedevice
Mechanism ofAction	Based on theclinician'streatment plan,each aligner isused for adefined period oftime to exert	Based on theclinician's treatmentplan, each aligner isused for a definedperiod of time toexert gentle force toachieve progressive	Sequential alignersapply continuousgentle force to theteeth	Same
	gentle force toachieveprogressiverealignment ofthe teeth. Thisoccurs over timeuntil the finalcorrection hasbeen achieved.	realignment of theteeth. This occursover time until thefinal correction hasbeen achieved.
Method ofUse	Each preformedplastic tray isworn by thepatient asprescribed by thedentalpractitioner,usually a fewweeks prior tousing the nextsequential alignertray.	Each preformedplastic tray is wornby the patient asprescribed by thedental practitioner,usually a few weeksprior to using thenext sequentialaligner tray.	Aligners are worn forapproximately 2weeks of 20-22hours of wear perday, after which it isreplaced by the nextstage aligners. Thisisrepeated for durationas prescribed by theDentalPractitioner	Same as thepredicatedevice
Method ofManufacture	Using software,molds/models are3D printed basedon the treatmentplan. Alignersare fabricated onthe molds using athermoformingmachine.	Using software,molds/models are3D printed based onthe treatment plan.Aligners arefabricated on themolds using athermoformingmachine.	The Align 3-DSoftware uses ascan of a PVSimpressionor a digital scan(which representsan untreatedstate) togenerate theimage of a final,treated state andthen interprets aseries of imagesthat representintermediate teethstates. The dentalpractitioner thenreviews theseimages and hasthe option toreject or requestmodifications tothe set-up prior toapproving it foralignerfabrication. Oncethe dentalpractitioner	Same as thepredicatedevice
			approves thetreatment plan,the softwareconverts the filesto produce theseries of custom-made aligners
Raw MaterialUsed	Thinthermoformedpolyurethane	Thin thermoformedpolyurethane	Thinthermoformedpolyurethane	Similar
OTC or Rx	Rx	Rx	Rx	Same
Software Use	3Shape OrthoSystem	3Shape OrthoSystem	InvisalignSystem 3-Dsoftware	Same as thepredicatedevice
Sterilization	No	No	No	Same

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Image /page/5/Picture/0 description: The image contains a logo with the text "3D GLOBAL BIOTECH". The "3D" is in green, while "GLOBAL BIOTECH" is in gray. The "3D" is a stylized graphic, and the text is aligned horizontally.

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Image /page/6/Picture/0 description: The image contains the logo for Global Biotech. On the left side of the logo is a green graphic that appears to be the number 3 with a circle attached to the right side of the number. To the right of the graphic is the text "GLOBAL BIOTECH" in gray. The text is stacked, with "GLOBAL" on top of "BIOTECH".

The DailyMate® Orthodontic Aligner System is substantially equivalent to the predicate device and the reference device. Both the subject and predicate devices use the same 510(k) cleared dental software 3Shape Ortho System (K152086) to translate tooth movements in developing the model schemes and allow the dental practitioner to review and approve the model schemes before aligner fabrication.

The bench tests using both the DailyMate® Orthodontic Aligner System and the Invisalign System were performed, the results of pH change test, water absorption change test and tensile strength change test showed that the DailyMate® Orthodontic Aligner System and the Invisalign System were substantial equivalent.

The differences among the subject device, the predicate device and the reference device lie in the variances in the aligner treatment plans which were customized for each individual patient. The associated risks have been mitigated by (1) A 510(k) requlated broadly recognized dental software, 3Shape Ortho System, is used for aligner design and review. (2) Every treatment plan receives a certified dental practitioner' approvals before aligners were manufactured. (3) The manufacturer is an ISO13485 certified facility which follows GMP standards during the manufacturing processes.

Non-Clinical performance Data

The DailyMate® Orthodontic Aligner System uses polyurethane as the raw material, same as the predicate device and reference device. The DailyMate® Orthodontic Aligner System is a device contacts mucosal membrane for a duration of greater than 30 days. The biocompatibility testing for the aligner materials was completed in accordance with ISO 10993 per the following:

Part 5: Cytotoxicity Test .
. Part 10: Sensitization Test
Part 10: Oral Mucosa Irritation Test ●

The testing results demonstrate that the material of DailyMate® Orthodontic Aligner System is biocompatible for the intended use.

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Image /page/7/Picture/0 description: The image shows the logo for Global Biotech. The logo consists of a green stylized "3D" on the left, followed by the words "GLOBAL" and "BIOTECH" stacked on top of each other in gray. The logo is simple and modern, and the use of green and gray gives it a clean and professional look.

The laboratory testing data was provided to confirm the quality of the DailyMate® Orthodontic Aligner System. A manufacturing validation report was also included to assure the substantial equivalence of the DailyMate® Orthodontic Aligner System.

Clinical performance Data

No clinical data was provided in this submission

Conclusion

The data included in this submission demonstrates that the DailyMate® Orthodontic Aligner System is substantially equivalent to the predicate device and the reference device in indications for use, mechanism of action, aligner design process, raw material and manufacturing fabrication process.

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.