Pearl Clear Aligner by Pearl Digital Inc.

Pearl Clear Aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to align teeth during the orthodontic treatment of malocclusions. They are made of biocompatible thermoplastic polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides a digital file (scan) of the patient's teeth to Pearl Digital. Based on the dental health professional's treatment plan, Pearl Digital develops a digital plan using commercially available treatment planning software. Upon approval by the dental health professional, molds are created with 3D-printing technology and the clear aligners are vacuum formed on the molds. The finished, customized aligners are provided to the dental health care professional who delivers the aligners to the patients in sequential stages checking for fit and function.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Pearl Clear Aligner. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria for the new device.

Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth for a performance study is not available within this document. The document mainly discusses the technical characteristics and biocompatibility testing of the Pearl Clear Aligner and compares them to the predicate device.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, specific quantitative acceptance criteria for the device's performance (e.g., accuracy of tooth movement, treatment success rates) are not detailed. The performance aspects highlighted are related to the manufacturing process validation and the general concept of applying forces for tooth alignment.

Acceptance Criteria (Implied/General)	Reported Device Performance (Summary)
Biocompatibility	Met requirements for ISO 10993 (Cytotoxicity, Oral Mucosal Irritation, Skin Sensitization, Acute Systemic Toxicity, Implantation, Subacute Systemic Toxicity, Subchronic Toxicity). Pyrogen Testing performed according to USP 45/NF40 <151>.
Manufacturing Process Accuracy	Bench testing performed to validate the manufacturing process to ensure the accuracy of the final aligners compared to the initial digital scans. A final report was part of the 510(k) package. (No specific metrics provided in this document)
Intended Use	"The Pearl Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by continuous gentle forces." (This is a statement of intended use, not a performance metric.)
Mode of Action	"The removable appliance applies continuous gentle forces on teeth according to the plan prescribed by the doctor." (Description of how it works, not a performance metric.)

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

The document mentions "Bench testing was performed to validate the manufacturing process to ensure the accuracy of the final aligners compared to the initial digital scans." However, the sample size for this test set is not specified.
Data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The manufacturing process validation likely involved internal technical experts, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

This information is not provided in the document.

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:

An MRMC comparative effectiveness study is not mentioned for this device. The device itself (Pearl Clear Aligner) is an orthodontic appliance, not a diagnostic AI system with human-in-the-loop interaction for interpretation. The "treatment planning software" is mentioned as a reference device, but no MRMC study involving it is described here.

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

This information is not applicable in the context of an orthodontic aligner device. While an algorithm is used for treatment planning (referencing PlaniMax Orthodontic Software, K201036), this document is for the aligner itself, and no standalone algorithm performance study for the aligner's effectiveness is detailed. The closest would be the "bench testing" to ensure manufacturing accuracy, which is a validation of the physical product, not a standalone algorithm performance.

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

For the "bench testing" of manufacturing accuracy, the "initial digital scans" (likely of the patient's teeth or desired final positions) served as the reference or ground truth against which the final aligners were compared.

8. The sample size for the training set:

The document implies that "commercially available treatment planning software is used" (referencing PlaniMax Orthodontic Software, K201036). If this software utilized a training set (as AI/ML software often does), its sample size is not specified in this document, as the document focuses on the aligner device.

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

As the document references an already cleared "commercially available treatment planning software," how its training set's ground truth was established is not detailed in this 510(k) submission for the Pearl Clear Aligner. That information would typically be part of the 510(k) for the software itself (K201036).

Summary

{0}------------------------------------------------

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.

January 16th, 2025

Pearl Digital Inc. % Patsv Trisler Regulatory Consultant Pear Digital Inc. 2975 Scott Blvd., Ste 110 Santa Clara, California 95054

Re: K242715

Trade/Device Name: Pearl Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: December 12, 2024 Received: December 12, 2024

Dear Patsy Trisler:

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.

{1}------------------------------------------------

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" (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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

{2}------------------------------------------------

assistance/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 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

{3}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242715

Device Name

Pearl Clear Aligner

Indications for Use (Describe)

The Pearl Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Submitter: Pearl Digital, Inc.

Pearl Clear Aligner K242715 Traditional Premarket Notification 510(k) SUBMITTER Name: Pearl Digital, Inc. 2975 Scott Blvd STE 110 Address: Santa Clara, CA 95054 Contact Person: | Henry H. Cao, CEO

Contact Person:	Henry H. Cao, CEO
Email:	henrycao@pearl-digital.com
Date Prepared:	December 12, 2024
DEVICE Trade Name:	Pearl Clear Aligners
Common Name:	Aligner, Sequential (Clear Braces)
Classification Name	Orthodontic Plastic Bracket
Number	21 CFR 872.5470
Product Code	NXC
Regulatory Class	2
Review Panel	Dental
PRIMARY PREDICATE:	K211510, uLab Systems Dental Aligner Kit, uLab Systems, Inc.
REFERENCE DEVICE:	K201036, PlaniMax Orthodontic Software, Choice Biotech Inc.
DEVICE DESCRIPTION	Pearl Clear Aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to align teeth during the orthodontic treatment of malocclusions. They are made of biocompatible thermoplastic polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides a digital file (scan) of the patient's teeth to Pearl Digital. Based on the dental health professional's treatment plan, Pearl Digital develops a digital plan using commercially available treatment planning software. Upon approval by the dental health professional, molds are created with 3D-printing technology and the clear aligners are vacuum formed on the molds. The finished, customized aligners are provided to the dental health care professional who delivers the aligners to the patients in sequential stages checking for fit and function.
MECHANISM OF ACTION	Each aligner in the set is used for the specified period of time, usually 1-2 weeks, to exert gentle forces to achieve progressive realignment of the teeth until the planned correction has been achieved. The daily treatment time is approximately 22 hours, or except during eating, based on the clinician's prescribed treatment plan. The aligner trays are held in place by pressure and can be removed by the patients at any time.
SUMMARY OFTECHNOLOGICALCHARACTERISTICS	The thermoplastic polyurethane material used for themanufacture of the Pearl Clear Aligner is similar to the materialused to make the predicate aligners.The treatment planning software system used is ChoiceBiotech, Inc's. PlaniMax Orthodontic Software, K201036(Reference device).
INDICATIONS FORUSE STATEMENT	The Pearl Clear Aligner is indicated for the alignment of teethduring orthodontic treatment of malocclusions by continuousgentle forces.
SAFETY TESTING	Testing according to ISO 10993, Biological evaluation ofmedical devices – Part 1: Evaluation and testing within a riskmanagement system, was performed by a GLP-certifiedcontract research laboratory:In vitro Cytotoxicity (Part 5) Oral Mucosal Irritation (Part 10) Skin Sensitization (Part 10) Acute Systemic Toxicity (Part 11) Implantation (Part 6) Subacute Systemic Toxicity (Part 11) Subchronic Toxicity (Part 11) Pyrogen Testing was performed according to USP 45/NF40<151>.
OTHER TESTING	Bench testing was performed to validate the manufacturingprocess to ensure the accuracy of the final aligners comparedto the initial digital scans. A final report was part of the 510(k)package.In vivo Animal and Human Clinical performance testing are notrequired for this device category.
COMPARISON TOTHE PREDICATEDEVICE	The Pearl Digital Aligners device has the same intended use asthe predicate device. The thermoplastic polymer material issimilar and the aligners are designed by commercially availabletreatment planning software (Reference Device). Theprocesses for fabrication of the clear aligners, while proprietaryto each manufacturer, make use of similar, industry-standardprocesses using similar machines and materials.Any differences in the materials, treatment planning softwareand specific manufacturing processes do not raise newquestions of safety and effectiveness.
SUBSTANTIALEQUIVALENCECONCLUSION	The information and data provided in this 510(k) establish thatthe Pearl Digital Aligners device is substantially equivalent tothe predicate device in the intended use, design, principle ofoperation, technology, including use of similar thermoplasticpolymer materials used to make the aligners. See the followingSE Comparison table.

{5}------------------------------------------------

{6}------------------------------------------------

Submitter: Pearl Digital, Inc.

510(k) Number	Proposed DeviceK242715	Predicate #1K211510	SE Comparison
Device Name	Pearl Clear Aligner	uLab Systems Dental AlignerKit	N/A
Manufacturer	Pearl Digital, Inc.	uLab Systems, Inc.	N/A
ClassificationRegulation	21 CFR 872.5470	21 CFR 872.5470	Same
NameProduct CodeClass	Orthodontic Plastic BracketNXC2	Orthodontic Plastic BracketNXC2
Indications forUse	The Pearl Clear Aligner isindicated for the alignment ofteeth during orthodontictreatment of malocclusions bycontinuous gentle forces.	The uLab Systems DentalAligner is indicated for thealignment of teeth duringorthodontic treatment ofmalocclusions by way ofcontinuous gentle forces.	Substantiallyequivalentintended use andIndications forUse statement
Mode of Action	The removable applianceapplies continuous gentleforces on teeth according tothe plan prescribed by thedoctor.	The removable applianceapplies continuous gentleforces on teeth according tothe plan prescribed by thedoctor.	Both applycontinuous gentleforces to achieveteeth realignment
Description ofUse	Each removable preformedplastic tray, prescribed by theDr, is worn by the patientusually for 1-2 weeks, prior tousing the next sequentialaligner tray according to Dr'sdirection.	Each removable preformedplastic tray, prescribed by theDr, is worn by the patientusually for 1-2 weeks, prior tousing the next sequentialaligner tray according to Dr'sdirection.	Wear time perday and persequential set issimilar.
Material	Thermoplastic polyurethane	Thermoplastic polyurethane	Both arethermoplasticsheets
ManufacturingProcess	Forming of plastic sheets onSD printed dental modelsdesigned with use of thetreatment planning software	Forming of plastic sheets onSD printed dental modelsdesigned with use of thetreatment planning software	Processes aredifferent(proprietary) butsimilar andaccording toindustrystandards.
Software	Commercially availabletreatment planning software isused.	Commercially availabletreatment planning software isused.	Software isdifferent but bothare commerciallyavailable fororthodontictreatmentplanning.
Prescription Use	Rx	Rx	Both requireprescription.
Biocompatibility	Testing to meet requirementsfor Category C	Testing to meet requirementsfor Category C	Standard ISO10993 testingconducted on thethermoplasticmaterials.
ProcessValidationTesting	Performed	Performed	Similar testingperformed.

Substantial Equivalence Comparison Table

{7}------------------------------------------------

Submitter: Pearl Digital, Inc.

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.