The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.

Device Description

The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The orthodontist uses the TPS (K200148) to select and order the patient-specific orthodontic brackets. The TPS allows the orthodontist to diagnose the patient, plan treatment, and position the orthodontic brackets based on a digital impression of the patient - the outcome of the TPS is a prescription for the patient-specific orthodontic brackets. The LFO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring, and modifying cases. LightForce Orthodontics' (LFO) operators and the orthodontists use the TPS to generate a prescription of their choosing. LFO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The LFO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.

AI/ML Overview

The provided text describes the LightForce Orthodontic System and its claim of substantial equivalence to a predicate device, the Signature Orthodontic System (K181271). However, it does not contain information related to software performance evaluation or clinical studies involving human readers or AI assistance. The document focuses solely on the physical properties and material equivalence of the orthodontic brackets.

Here's an analysis based on the information provided, specifically addressing the questions where applicable:

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

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance testing where the LightForce Orthodontic System (LFO System) brackets were compared to the predicate device, the Signature Orthodontic System. The reported performance is consistently framed as "equivalent to or better than" the predicate device.

Test Type	Acceptance Criteria (Not Explicitly Stated, Implied Comparison)	Reported Device Performance (LightForce Orthodontic System)
Shear Bond Strength	Equivalent to or better than predicate device	Equivalent to or better than the predicate device
Torque Strength	Equivalent to or better than predicate device	Equivalent to or better than the predicate device
Friction (wire drag) Force	Equivalent to predicate device	Equivalent to the predicate device
Tensile Bond Strength	Equivalent to predicate device	Equivalent to the predicate device
Tie-wing Tensile Fracture Strength	Equivalent to predicate device	Equivalent to the predicate device

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the bench tests.
The data provenance is not specified (e.g., country of origin, retrospective or prospective). These were bench tests, so "provenance" might refer to the lab where they were conducted, which is not mentioned.

3. 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)

This question is not applicable as the evaluation involved bench testing of physical properties of orthodontic brackets, not interpretation of data by human experts to establish "ground truth." There was no "test set" in the context of human interpretation or AI performance assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for the same reason as point 3. There was no human interpretation or adjudication involved.

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

The document explicitly states: "No clinical performance testing was conducted on LFO System brackets." Therefore, no MRMC study was performed, and there is no information on human reader improvement with or without AI assistance. The focus of this submission is on the physical properties of the brackets, not on the AI capabilities of the treatment planning software.

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

While the LightForce Orthodontic System includes "treatment planning software (TPS)", the document focuses on the orthodontic appliance system (the brackets). The non-clinical performance testing described is for the brackets themselves, not the standalone performance of the algorithm within the TPS. The document does not provide details on standalone algorithm performance.

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

For the bench tests of the brackets, "ground truth" implicitly refers to the measured physical properties and mechanical performance of the predicate device (Signature Orthodontic Brackets), against which the LFO System brackets were compared. This is a property-based or measurement-based ground truth, not expert consensus or pathology.

8. The sample size for the training set

This question is not applicable as the document describes bench testing of physical orthopedic devices and does not mention any training set for an AI model.

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

This question is not applicable for the same reason as point 8.

Summary

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September 14, 2022

LightForce Orthodontics % Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K222764

Trade/Device Name: LightForce Orthodontic System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NJM, PNN Dated: September 12, 2022 Received: September 13, 2022

Dear Prithul Bom:

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, 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

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Indications for Use

510(k) Number (if known) K22764

Device Name LightForce Orthodontic System

Indications for Use (Describe)

The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 S

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Tab 5

510(k) Summary

510(k) SUMMARY LightForce Orthodontics' LightForce Orthodontic System

Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared LightForce Orthodontics 44 Third Ave Burlington, MA 01803

Phone: 800-481-0185 Email: kelsey@lightforceortho.com

Contact Person: Kelsey Fafara

Date Prepared: August 10, 2022

Name of Device and Name/Address of Sponsor

LightForce Orthodontic System

LightForce Orthodontics 44 Third Ave Burlington, MA 01803

Trade/Proprietary Name of Device: LightForce Orthodontic System

Common or Usual Name: Orthodontic Ceramic Bracket and Accessory

Classification Name: Orthodontic Ceramic Bracket, 21CFR§872.5470

Regulatory Class: II

Product Code: NJM

Predicate Devices:

Primary Predicate: Signature Orthodontics' Signature Orthodontic System (K181271)

Trade/Proprietary Name of Device: Signature Orthodontic System

Common or Usual Name: Orthodontic Ceramic Bracket and Accessory

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Classification Name: Orthodontic Ceramic Bracket, 21CFR§872.5470, Product code: NJM

Device Description

Intended Use / Indications for Use

The indications for use are the same between this submission and the primary predicate K181271.

The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patient-matched orthodontic appliances.

The LightForce Orthodontic System in the primary predicate (K181271) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. This current submission provides hardware updates to the hardware delivered in the primary predicate.

Technological Characteristics

LightForce Orthodontic System is similar to other legally marketed devices - while the patient-specific ceramic brackets are equivalent to the Signature Orthdontic Brackets of K181271. Table 6-1 provides a comparison of the LFO System to the predicate devices.

The LFO System patient-specific brackets, like its predicate Signature Orthodontic, are composed of a polycrystalline alumina with a twin bracket design consisting of tie-wings for ligation, a primary arch wire slot and auxiliary slots. There are rounded corners and edges along with a rounded hook on the distal-gingival tie wing of canine brackets to accommodate accessories during orthodontic treatment. These design features allow a ligature wire, in tension, to move the bonded brackets along a designated path until the desired tooth position is

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achieved. The brackets are non-self-ligating with a mechanical locking base design and built through additive manufacturing methods.

Non-clinical Performance Testing

Bench testing was performed to ensure that the patient-specific brackets were similar to the LFO System predicate, Signature Orthodontic System. Performance testing consisted of shear bond strength and torque strength. Tensile testing, wire friction testing and bracket strength (fracture) testing were also completed as comparison tests.

1. Shear bond strength is the load per unit area required to remove a bonded bracket from a tooth when a shear force is applied in the occlusal-gingival direction. The shear bond strength of LFO System brackets is equivalent to or better than the predicate device.
1. Torque strength is the torque exerted on the bracket at fracture, when subjected to arch wire torsion. The torque strength of LFO System brackets is equivalent to or better than the predicate device.
1. Friction (wire draq) force is the force required to drag a ligated stainless-steel wire through the primary slot of the bracket. The friction (wire drag) force of the LFO System brackets is equivalent to the predicate device.
1. Tensile bond strength is the load per unit area required to remove a bonded bracket from a tooth when a tensile force is applied to a stainless-steel wire ligated to the primary slot of the bracket. The tensile bond strength of LFO System brackets is equivalent to the predicate device.
1. Tie-wing tensile fracture strength is the fracture strength of the tie-wing complex when a tensile load is placed directly under the tie wing. The tie wing tensile fracture strength of LFO System brackets is equivalent to the predicate device.

Clinical Performance Testing

No clinical performance testing was conducted on LFO System brackets.

Device Comparison Tables

The following table, Table 5-2, provide a comparison of the device features, functions, and performance characteristics between the LightForce Orthodontic System (LFO System) and its predicate devices.

Table 5-2: Comparison of LFO System and Predicate Devices
ITEM	PRIMARY PREDICATESignature OrthodonticSystem K181271	LightForce OrthodonticSystem	Similaritiesordifferences
Description	The Signature OrthodonticSystem (SO System) is atreatment planning software(TPS) and orthodonticappliance system used tocorrect malocclusions inorthodontic patients usingpatient-matchedorthodontic appliances.The SO Systemconsists of patient-specificceramic brackets, patient-specific bracket placementjigs, arch wire templates, anda TPS for viewing, measuring,and modifying cases.SignatureOrthodontics' (SO) operatorsand the orthodontists use theTPS to generate a prescriptionof their choosing. SO thenmanufactures thepatient-specific brackets andplacement jigs usingproprietary additivemanufacturing techniques. Theorthodontist then bondsthe brackets to the teeth usingthe optional placement jig andligates wires to enable toothmovement. The SO Systemdoes not containcommercially-available orpatient-specific shaped archwires, ligatures, or adhesivesthat affixes the brackets to theteeth.	The LightForce OrthodonticSystem (LFO System) is atreatment planning software(TPS) and orthodonticappliance system used tocorrect malocclusions inorthodontic patientsusing patient-matchedorthodontic appliances.The LFO Systemconsists of patient-specificceramic brackets, patient-specific bracket placementjigs, arch wire templates, anda TPS for viewing, measuring,and modifying cases.LightForceOrthodontics' (LFO) operatorsand the orthodontists use theTPS to generate a prescriptionof their choosing. LFO thenmanufactures thepatient-specific brackets andplacement jigs usingproprietary additivemanufacturing techniques. Theorthodontist then bondsthe brackets to the teeth usingthe optional placement jig andligates wires to enable toothmovement. TheLFO System does not containcommercially-available orpatient-specific shaped archwires, ligatures, or adhesivesthat affixes the brackets to theteeth.	Identical
ProductCodes /Regulations	NJM (Orthodontic CeramicBracket, 21CFR§872.5470)	NJM (Orthodontic CeramicBracket, 21CFR§872.5470)	Identical
Indicationsfor Use	The Signature OrthodonticSystem is a treatment planningsoftware and orthodonticappliance system used tocorrect malocclusions inorthodontic patients using	The LightForce OrthodonticSystem is a treatment planningsoftware and orthodonticappliance system used tocorrect malocclusions inorthodontic patients using	Identical
	patient-matched orthodonticappliances.	patient-matched orthodonticappliances.
SequenceofTreatmentPlan orMode ofUse	Signature Orthodontics (SO)receives the patient's digitaldata via commerciallyavailable communicationstools from the DDS/DMD. SOprepares a final tooth setupand bracket placement planand returns the digital databack to the DDS/DMD. Theorthodontist can then view,measure and modify the caseusing the TPS. Onceapproved, brackets and jigsare manufactured and shippedto the DDS/DMD.	LightForce Orthodontics (LFO)receives the patient's digitaldata via commerciallyavailable communicationstools from the DDS/DMD. LFOprepares a final tooth setupand bracket placement planand returns the digital databack to the DDS/DMD. Theorthodontist can then view,measure and modify the caseusing the TPS. Onceapproved, brackets and jigsare manufactured and shippedto the DDS/DMD.	Identical
BracketMaterial	Polycrystalline AluminaCeramic	Ceramic	Identical
Manufacturing Method	3D printed	3D Printed	Identical
AnalysisMethods	N/A	N/A	Identical
Non-sterile,single use	Yes	Yes	Identical
BracketBase	Mechanical Lock Base	Mechanical Lock Base	Identical
BracketDesign	Arch wire slot, tie wings forligature, and identificationmarks for placement. Hooksfor ligation, for additional toothmovement. Printed ceramicbody with rounded corners andedges. Slot to hold orthodonticwires. Non-self-ligating	Arch wire slot, tie wings forligature, and identificationmarks for placement. Hooksfor ligation, for additional toothmovement. Printed ceramicbody with rounded corners andedges. Slot to hold orthodonticwires. Non-self-ligating	Identical

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Substantial Equivalence

The LightForce Orthodontic System (LFO System) is the same as the predicate device; Signature Orthodontic Brackets. The LFO System has the same intended uses/indication for uses, technological characteristics, and principles of operation as its predicate devices. The performance data provided above demonstrates that the LFO System performs at an equivalent

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or better level compared to Signature Orthodontic Brackets. The minor technological differences between the LFO System and the predicate device, Signature Orthodontic brackets, raise no new issues. There are no alterations in the intended use or the underlying technology or science involved. Thus, the LightForce Orthodontic System is the same as its predicates.

Conclusion

Additionally, the LFO System has the same intended use, composition, design, function, physical properties and performance as its predicate devices. As shown in our performance data, the difference in manufacturing method does not impact the device's intended use and performance. The results from the nonclinical performance testing and the biocompatibility assessment demonstrate that LFO System brackets, along with the appropriate arch wires, constitute standard orthodontic appliances which are equivalent to existing appliances used in the clinical environment.

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.