The DigiLine Direct Print Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The DigiLine Direct Print Aligner System repositions teeth by way of continuous gentle force.

Device Description

The Proposed Device, DigiLine Direct Print Aligner System consists of multiple stages of 3D printed plastic aligners designed to be worn in sequence to facilitate the movement of a patient's teeth to the final desired treatment position. The sequential stages of aligners introduce incremental movements that move teeth by way of gentle continuous force to achieve a more optimal bite profile. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning.

The Proposed Device is designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential stages of dental models are designed and approved by a physician prior to physical manufacturing. Once the treatment plan is reviewed and approved by a dental health professional, each aligner stage is fabricated by additive manufacturing, specifically 3D printing. The 3D printed aligner then undergoes post-processing and cleaning prior to packaging for patient use. DigiLine Direct Print Aligner System are direct-printed using DigiLine Direct Print Resin. DigiLine Direct Print Resin is a light-cured, methacrylate-based resin. Methacrylate-based resins are commonly used for the production of dental structures.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Device Name: DigiLine Direct Print Aligner System
Regulation Name: Orthodontic Plastic Bracket
Product Code: NXC
Predicate Device: Tera Harz Clear (K223355)
Reference Device: LuxCreo Clear Aligner (K212680)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for device performance (e.g., a specific percentage of dimensional accuracy or a force measurement). Instead, it describes general compliance with standards and internal specifications. The performance is assessed by demonstration of manufacturing validation and material testing meeting requirements.

Acceptance Criteria Category	Specific Acceptance Criteria (as implied)	Reported Device Performance
Manufacturing Validation	Capable of successfully fabricating the device; dimensional accuracy and quality of aligners meet pre-established criteria.	Manufacturing validation was performed, demonstrating the additive manufacturing process is capable of successfully fabricating the DigiLine Direct Print Aligner System. The dimensional accuracy and quality of the aligners resulting from the process met the pre-established acceptance criteria.
Material Testing	Meet internal design specifications and applicable performance standards (specifically ISO 20795-2:2013).	Material testing was conducted on the aligner material, meeting internal design specifications and the applicable performance standard ISO 20795-2:2013.
Biocompatibility	Meet requirements of ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process."	Biocompatibility testing was conducted for the aligner material (the only patient-contacting aspect) in accordance with ISO 10993-1. All testing met the requirements of the applicable standard.
Clinical Equivalence	The device is as safe, as effective, and performs as well as or better than legally marketed devices.	The conclusion from the non-clinical testing (manufacturing, material, biocompatibility) is that the DigiLine Direct Print Aligner System is as safe, as effective, and performs as well as or better than the legally marketed predicate and reference devices. Clinical testing was not required.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for any test sets.
Data Provenance: The document does not provide information about the country of origin of the data or whether the studies were retrospective or prospective. Given that no clinical studies were performed, this information is not applicable to patient data. The non-clinical tests would have been performed in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This submission relies on non-clinical performance testing (manufacturing validation, material testing, biocompatibility) against established standards rather than clinical data requiring expert review for ground truth.

4. Adjudication Method for the Test Set

Not applicable. As no clinical studies requiring expert review for ground truth were conducted, there was no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states, "Clinical Testing was not required for the Predicate Device or the DigiLine Direct Print Aligner System."
Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. The device is a physical orthodontic aligner system, not an AI software.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The DigiLine Direct Print Aligner System is a physical orthodontic device manufactured using 3D printing. It is not an algorithm or AI software for which standalone performance would be measured. While a "digital scan" is used for design, the core device under review is the physical aligner.

7. Type of Ground Truth Used

The "ground truth" for proving the device meets acceptance criteria is based on engineering standards, internal design specifications, and quality control metrics established for manufacturing, materials, and biocompatibility.
Specifically:
- Compliance with ISO 20795-2:2013 for material performance.
- Compliance with ISO 10993-1 for biocompatibility.
- Demonstration of successful fabrication and meeting pre-established dimensional accuracy and quality criteria during manufacturing validation.

8. Sample Size for the Training Set

Not applicable. This section relates to the training of an AI algorithm. The DigiLine Direct Print Aligner System is a physical medical device. The "design" phase involves digital scans and physician approval, but this is distinct from a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no AI algorithm training set for this physical device.

Summary

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April 5, 2024

Park Dental Research Corporation % Logan Simmons Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043

Re: K233935

Trade/Device Name: DigiLine Direct Print Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: March 19, 2024 Received: March 19, 2024

Dear Logan Simmons:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 E. Adjodha, M. ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and

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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

Submission Number (if known)

K233935

Device Name

DigiLine Direct Print 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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K233935

510(k) Summary

Prepared on: 2024-03-19

Contact Details	21 CFR 807.92(a)(1)
-----------------	---------------------

Applicant Name	Prime Path MedTech
Applicant Address	1321 Upland Drive Suite 6792 Houston TX 77043 United States
Applicant Contact Telephone	440-387-9788
Applicant Contact	Mrs. Logan Simmons
Applicant Contact Email	lsimmons@primepathmedtech.com

Device Name	21 CFR 807.92(a)(2)
-------------	---------------------

Device Trade Name	DigiLine Direct Print Aligner System
Common Name	Orthodontic plastic bracket
Classification Name	Aligner, Sequential
Regulation Number	872.5470
Product Code	NXC

Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
------------------------------------	---------------------

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K223355	Tera Harz Clear	NXC
K212680	LuxCreo Clear Aligner	NXC

Device Description Summary	21 CFR 807.92(a)(4)
----------------------------	---------------------

The Proposed Device, DigiLine Direct Print Aligner System consists of multiple stages of 3D printed plastic
aligners designed to be worn in sequence to facilitate the movement of a patient's teeth to the final
desired treatment position. The sequential stages of aligners introduce incremental movements that
move teeth by way of gentle continuous force to achieve a more optimal bite profile. The aligners are to
be worn 20 to 22 hours a day and are to be removed for eating and for cleaning.

The Proposed Device is designed from digital scans of a patient's dentition submitted by a dental health
professional (e.g. dentist or orthodontist). Using the scan, sequential stages of dental models are designed
and approved by a physician prior to physical manufacturing. Once the treatment plan is reviewed and
approved by a dental health professional, each aligner stage is fabricated by additive manufacturing,
specifically 3D printing. The 3D printed aligner then undergoes post-processing and cleaning prior to packaging for patient use. DigiLine
Direct Print Aligner System are direct-printed using DigiLine Direct Print Resin. DigiLine Direct Print Resin is a light-cured, methacrylate-
based resin. Methacrylate-based resins are commonly used for the production of dental structures.

Intended Use/Indications for Use	21 CFR 807.92(a)(5)
----------------------------------	---------------------

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

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The Proposed Device in this submission is the Predicate Device (Tera Harz Clear, K223355) as they are both indicated for use in the alignment of teeth through orthodontic treatment of malocclusion. It can be used permanent dentition with a wear time 20 to 22 hours a day for 1-2 weeks or as prescribed by the treating physician.The indications for use of the Proposed Device, Predicate Device (Tera Harz Clear, K223355), and the previously cleared Reference Device (LuxCreo Clear Aligner, K22680) do not raise questions of substantial equivalence. The Proposed Device guides patients' teeth to their desired treated position by way of continuous gentle forces in sequential aligner stages. The Predicate Device (Tera Harz Clear, K223355) indication does not differ from the Proposed device in the

functionality of the device. The Predicate (Tera Harz Clear, K223355) also lists compatible orthodontic software, 3D printers and curing units. The indications for use is the exact same as the Reference Device (LuxCreo Clear Aligner, K212680). Thus, the Proposed Device can be considered substantially equivalent to the Predicate Device (Tera Harz Clear, K223355) and Reference Device (LuxCreo Clear Aligner, K212680).

Technological Comparison

21 CFR 807.92(a)(6)

The technological characteristics of DigiLine Direct Print Aligner System is the Tera Harz Clear (K223355). Both products are fabricated from a methacrylate-based resin that undergoes to harden the appliance. Thus, DigiLine Direct Print Aligner System can be considered substantially equivalent to its predicate device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Performance Testing was conducted in accordance with ISO 20795-2:2013.

A manufacturing validation was performed to demonstrate that the additive manufacturing process is capable of successfully fabricating DigiLine Direct Print Aligner System. The dimensional accuracy of the manufacturing process and the quality of the aligners resulting from the pre-established acceptance criteria.

Additionally, material testing was conducted on the aligner material according to internal design specification and with the applicable performance standards (ISO 20795-2:2013). Biocompatibility testing for the aligner material, the only patient contacting aspect, was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." All testing met the requirements of the applicable standard.

Clinical Testing was not required for the Predicate Device or the DigiLine Direct Print Aligner System.

Testing has demonstrated that the DigiLine Direct Print Aligner System is as safe, as effective, and performs as well as or better than the legally marketed devices referenced above.

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.