STR8 Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth 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 20 to 22 hours a day and are to be removed for eating and for cleaning.

STR8 Clear Aligners are designed from digital scans of a patient's dentition. Using the scan, specialized orthodontic CAD/CAM software will be used to develop the treatment plans that consist of sequential dental models wherein the teeth are gradually realigned with each step. For this 510(k), ArchForm Treatment Planning System (K213916) will be used for this application. ArchForm is approved for use in the management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.

Once the treatment plan is reviewed and approved by a STR8 Oral Care 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 then provided to the patient by the prescribing dental professional group.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "STR8 Clear Aligners." It is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study showcasing AI model performance.

Therefore, the document does not contain the specific information required to answer your questions about acceptance criteria for an AI model, the study proving it meets those criteria, sample sizes, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.

The document discusses the following:

Device Description: STR8 Clear Aligners are thermoformed plastic aligners for orthodontic treatment.
Comparison to Predicate Device: The document extensively compares the STR8 Clear Aligners to a predicate device (uLab Systems Dental Aligner Kit, K211510) across various specifications like regulation, classification, materials, indications for use, and manufacturing process. The goal is to show the new device is "substantially equivalent."
Non-Clinical Performance Testing: This section mentions durability testing and an internal manufacturing validation to ensure dimensional accuracy (measurements within 0.3 mm of target).
Biocompatibility Testing: Conducted according to ISO 10993-1 and ISO 10993-5.
Clinical Performance Testing: States that no clinical studies were deemed necessary because of the similarities to the predicate device.

To directly answer your questions based only on the provided text, the answer for almost all points is that this information is not present or not applicable to an AI model evaluation.

Here's why, addressing each of your points:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for the 510(k) process: The primary acceptance criterion here is "substantial equivalence" to a legally marketed predicate device. This is demonstrated by showing similar indications for use, technological characteristics, and materials.
- Reported Device Performance: The document reports that for non-clinical performance testing, "All measurements were within 0.3 mm of the target input value" for manufacturing accuracy, and "no performance, cosmetic, or other detectable issues were identified" during qualitative assessment. Biocompatibility testing was also conducted and presumably met relevant standards.
- No AI-specific acceptance criteria or performance metrics are provided.
Sample sized used for the test set and the data provenance: Not applicable. This document describes a 510(k) submission for a physical aligner, not an AI test set. The manufacturing validation involved assessing intraoral scans, digital models, 3D printed molds, and thermoformed aligners, but specific sample sizes for this internal validation are not detailed beyond "All measurements."
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. "Ground truth" in the context of an AI model assessment is not relevant to this submission. The "ground truth" for the device's function is its ability to align teeth as prescribed, which is assumed to be similar to the predicate based on design and materials.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human expert review/adjudication of an AI model's output is mentioned.
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 submission does not involve an AI assistant for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. The device relies on a "specialized orthodontic CAD/CAM software" (ArchForm Treatment Planning System, K213916) for treatment planning, which itself has a 510(k) clearance, but this document does not evaluate its standalone performance, only its use as a tool in the aligner's manufacturing process.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the manufacturing validation, the "ground truth" was the "target input value" from the digital treatment plan. For the overall device, the implicit "ground truth" for showing substantial equivalence is the established safety and effectiveness of the predicate device (uLab Systems Dental Aligner Kit).
The sample size for the training set: Not applicable. This is not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a regulatory filing for a physical medical device (clear aligners) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information related to the rigorous testing and validation of an AI model.

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 24, 2023

STR8 Oral Care % Elisabeth Miller Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043

Re: K223141

Trade/Device Name: STR8 Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: February 21, 2023 Received: February 21, 2023

Dear Elisabeth Miller:

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)

K223141

Device Name STR8 Clear Aligners

Indications for Use (Describe)

The STR8 Clear Aligner is indicated for the aligment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

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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Section 5. 510(k) Summary

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

Submitter:	STR8 Oral Care
Company Contact Person:Address:Phone:Email:	Misee Harris217 E Cherry Ave Jonesboro, AR 72401931-797-1821miseeharris@cdcjonesboro.com
Submission Correspondent:Address:Phone:Email:	Elisabeth Miller, Regulatory Affairs Consultant1321 Upland Dr. Suite 6792 Houston, TX 77043(586) 242-7718emiller@primepathmedtech.com
Date Prepared:	September 2022
Proprietary Name:	STR8 Clear Aligners
Common Name:	Sequential Clear Aligner
Product Code:	NXC – Orthodontic plastic bracket
Device Classification:	Class II, 21 CFR 872.5470
Predicate Device:	uLab Systems Dental Aligner (K211510)
Classification Name:	Aligner, Sequential

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Device Description:

Indications for Use:

The STR8 Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

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Comparison to Predicate Devices:

STR8 Clear Aligners are functionally equivalent to the following predicate device: uLab Systems Dental Aligner Kit (K211510).

Specification	Subject Device:	Predicate Device:	Comparison Result
	STR8 Clear Aligners	uLab Systems Dental Aligner Kit (K211510)
Regulation Number	21 CRF 872.5470	21 CRF 872.5470	Same
Classification Name	Aligner, Sequential	Aligner, Sequential	Same
Product Code	NXC	NXC	Same
Classification	Class II	Class II	Same
OTC or Rx	Rx	Rx	Same
Material	Zendura FLX (copolyester and polyurethane composite)	Zendura A (thin thermoformed polyurethane) or Zendura FLX (copolyester and polyurethane composite)	Similar (Zendura A) or Same (Zendura FLX)
Biocompatible	Yes	Yes	Same
Sterile	No	No	Same
Device Description	A series of customized removable clear plastic orthodontic aligners that sequentially position teeth by way of continuous gentle force.	A series of customized removable clear plastic orthodontic aligners that sequentially position teeth by way of continuous gentle force.	Same
Patient Removable?	Yes	Yes	Same
Indication for Use	The STR8 Clear Aligner is indicated for the alignment of teeth during	The uLab Systems Dental Aligner is indicated for the alignment of teeth during	Same
	orthodontic treatment ofmalocclusions by way ofcontinuous gentle forces.	orthodontic treatment ofmalocclusions by way ofcontinuous gentle forces.
Intended Use	Orthodontic ToothMovement	Orthodontic ToothMovement	Same
Principles ofOperation	Each preformed plastictray is worn in sequenceby the patient asprescribed by the dentalpractitioner. Orthodonticmovement occurs throughcontinuous gentle forcesapplied to the dentition aseach tooth follows theprogrammeddisplacement based onthe doctor's prescription.	Each preformed plastictray is worn in sequenceby the patient asprescribed by the dentalpractitioner. Orthodonticmovement occurs throughcontinuous gentle forcesapplied to the dentition aseach tooth follows theprogrammeddisplacement based onthe doctor's prescription.	Same
Aligner DesignProcess	Standard dental softwarefor tooth alignment usesdigital scan (untreatedstate) to generate theimage of a final,provisional treated stateand then interprets aseries of images thatrepresent intermediateteeth states. The dentalpractitioner then reviewsthese images and has theoption to reject or requestmodifications to the set-up prior to approving foraligner fabrication. Oncethe dental practitionerapproves the treatmentplan, the softwareconverts the files toproduce a series 3Dmodels used to producethermoformed aligners.	Standard dental software,including the uLabSystems uDesign.K171295, for toothalignment uses digitalscan (untreated state) togenerate the image of afinal, provisional treatedstate and then interpretsa series of images thatrepresent intermediateteeth states. The dentalpractitioner then reviewsthese images and has theoption to reject, make orrequest modifications tothe set-up prior toapproving it for alignerfabrication. Once thedental practitionerapproves the treatmentplan, the softwareconverts the files toproduce the series of 3Dmodels used to producethermoformed aligners.	Same

Table 1. Predicate Device Comparison

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Comparison for Indications for the Use to Predicate Device:

Based on the above comparison, the indications for use of the STR8 Clear Aligners in this submission is the same as the uLab Systems Dental Aligner Kit (K211510) as they are both indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces. Thus, the STR8 Clear Aligners can be considered substantially equivalent to its predicate device.

Comparison of Technical Characteristics to Predicate Device

Based on the above comparison, the design, construction, and performance characteristics of the STR8 Clear Aligners is similar to that of the uLAB Systems Dental Aligner Kit (K211510).

The only difference between the subject device (STR8 Clear Aligner) and predicate device (uLab Systems Dental Aligner Kit) is the material differences come from the additional material (Zendura A) used for the predicate device. The expansion of material does not increase the risk associated with manufacturing, and the subject device and predicate device do share an exact material, Zendura FLX.

Thus, the STR8 Clear 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. However, durability testing was completed on these 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.

An internal manufacturing validation was performed to establish the dimensional accuracy of the manufacturing process for the STR8 Clear Aligners. The submitted intraoral scans, digital dentition models, from treatment planning, 3D printed molds and the final thermoformed aligners were all assessed quantitatively in the validation. Thus, the robustness of the process was demonstrated from 3D printing through thermoforming.

All measurements were within 0.3 mm of the target input value, the predefined tolerance of the manufacturing process. Furthermore, throughout the qualitative assessment of the aligners no performance, cosmetic, or other detectable issues were identified. This validation has met the pre-established acceptance criteria to demonstrate that the STR8 manufacturing process yields dimensional accurate products that meet product specifications.

The dental thermoplastic material used for STR8 Clear Aligners is a well-establish and commonly used thermoplastic, Zendura FLX. Biocompatibility testing for the aligner

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material, the only patient contacting material, was conducted by the manufacturer in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on final manufactured STR8 Clear Aligners.

Clinical Performance Testing

The technical characteristics, indications for use, material, manufacturing, and sterilization processes are the same to the predicate device and therefore, no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device.

Conclusion

Based on the similarities in indications for use, technological characteristics, and materials the STR8 Clear Aligners are substantially equivalent to the uLab Systems Dental Aligner Kit (K211510)

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.