(30 days)
The LightForce Orthodontic System is a treatment planning software (TPS) and Orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
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 LFO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring,modifying cases and submitting orders. 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.
The change is to upgrade LFO System's Treatment Planning Software (TPS) from version 3.1 to version 4.0. TPS version 3.1 was originally cleared in K183542 and the LFO System was originally cleared in K181271. TPS version 4.0 provides improved software architecture, updated hosting infrastructure and improvements to the user interface to better match the intended use of the product based on customer feedback and validation input.
A comparison of TPS 3.1 and TPS 4.0 shows that both software provide the same features and functional workflows is evidence of substantial equivalence. The replacement software is identical in performance and function to the previously used software.
The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system designed to correct malocclusions using patient-matched orthodontic appliances. The current submission (K200148) focuses on an upgrade to the Treatment Planning Software (TPS) from version 3.1 to version 4.0.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly define quantitative "acceptance criteria" with specific thresholds that the device must meet for performance metrics. Instead, the study aims to demonstrate equivalence between the new TPS version 4.0 and the previously cleared TPS version 3.1. The performance criteria are functional aspects of the software, and the reported performance is simply "Equivalent (Test Report)".
| Functional Area | Acceptance Criteria (Implied) | Reported Device Performance (LFO System TPS 4.0) |
|---|---|---|
| 4.1 Diagnosis - Viewing | Viewing of patient's digital impression is identical to TPS 3.1. | Equivalent (Test Report) |
| 4.1 Diagnosis - Successful Diagnosis | Successful diagnosis of patient's malocclusion is identical to TPS 3.1. | Equivalent (Test Report) |
| 4.2 Planning - Successful Movement (Teeth) | Successful movement of patient's teeth (within software) is identical to TPS 3.1 or improved. | Equivalent (Test Report) and "Improved movement accuracy by moving around desired axis" for TPS 4.0 compared to TPS 3.1 in Feature Comparison table. |
| 4.3 Planning - Successful Movement (Brackets) | Successful movement of brackets is identical to TPS 3.1. | Equivalent (Test Report) |
| 4.4 Data Handling - Case Delivery | Case delivered securely and uncorrupted is identical to TPS 3.1. | Equivalent (Test Report) |
| Software Features (e.g., Rotate, Zoom, Pan Impression, Hide/Show arches) | These basic user interface functionalities are identical to TPS 3.1. | Identical (in feature comparison table) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific "sample size" for the test set used to validate TPS 4.0. The validation activities are described as "Validation testing of the TPS was performed in accordance with LFO's design control activities for software and to the software's Test Plan."
The data provenance (country of origin, retrospective/prospective) is not mentioned. Given it's a software upgrade validation, it's likely internal testing rather than clinical study data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the software validation. The testing seems to be internal validation against a "Test Plan" and comparison to functionality of the previous software version.
4. Adjudication method for the test set
The document does not describe an adjudication method for the test set results. The determination of "equivalence" likely relied on direct comparison of functionalities and outputs against predefined test cases within the "Test Plan."
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 multi-reader multi-case (MRMC) comparative effectiveness study was done or reported in this submission. The submission is focused on a software upgrade for a treatment planning system and does not involve AI assistance for human readers in a diagnostic capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation of the algorithm (TPS 4.0) against its predecessor (TPS 3.1) was performed. "Validation testing of the TPS was performed in accordance with LFO's design control activities for software and to the software's Test Plan." The results in Table 6-1 compare the performance of TPS 4.0 directly to TPS 3.1 across various functional areas. This is essentially a standalone comparison of the software versions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the software validation appears to be the expected functional behavior and outputs as defined by the "Test Plan" for the software, and by direct comparison to the performance of the legally marketed predicate software (TPS 3.1). For example, the software's ability to "view patient's digital impression," "move patient's teeth," or "deliver case securely" would be verified against predetermined correct outcomes or the established behavior of the prior version. It is not based on expert consensus on clinical cases, pathological findings, or patient outcomes data.
8. The sample size for the training set
This submission pertains to the validation of a software upgrade (TPS 4.0 to TPS 3.1). It is not a submission for a de novo AI/ML algorithm that requires a training set in the traditional sense. The software's development would have involved internal testing and refinement, but a specific "training set" for an AI model is not applicable here as the primary claim is functional equivalence and improvement of an existing treatment planning software.
9. How the ground truth for the training set was established
As noted above, this submission does not involve a "training set" for an AI/ML algorithm in the context of establishing ground truth for training. The software's capabilities are based on its design and implementation for treatment planning, not on learning from a labeled dataset.
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February 21, 2020
LightForce Orthodontics % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K200148
Trade/Device Name: LightForce Orthodontic System (LFO System) Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: PNN, NJM Dated: January 21, 2020 Received: January 22, 2020
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.
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
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gencies. You must comply with all the Act's
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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 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-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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K200148
Device Name
LightForce Orthodontic System
Indications for Use (Describe)
The LightForce Orthodontic System is a treatment planning software (TPS) 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 Subpart C) |
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TAB 6 - 510(k) Summary
K200148 - 510(k) SUMMARY
LightForce Orthodontics' LightForce Orthodontic System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
LightForce Orthodontics 1035 Cambridge Street Cambridge, MA 02141
Phone: 800-481-0185 Facsimile: N/A Email: amos@lightforceortho.com
Contact Person: Amos N Benninga
Date Prepared: February 20, 2020
Name of Device and Name/Address of Sponsor
LightForce Orthodontic System LightForce Orthodontics 1035 Cambridge Street Cambridge, MA 02141
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
Primary Predicate: LightForce Orthodontics' LightForce Orthodontic System (K183542) Reference Device: LightForce Orthodontics' LightForce Orthodontic System (K181271)
(Note: Previously known as Signature Orthodontic System)
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Device Description and Justification
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 LFO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring,modifying cases and submitting orders. 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.
The change is to upgrade LFO System's Treatment Planning Software (TPS) from version 3.1 to version 4.0. TPS version 3.1 was originally cleared in K183542 and the LFO System was originally cleared in K181271. TPS version 4.0 provides improved software architecture, updated hosting infrastructure and improvements to the user interface to better match the intended use of the product based on customer feedback and validation input.
A comparison of TPS 3.1 and TPS 4.0 shows that both software provide the same features and functional workflows is evidence of substantial equivalence. The replacement software is identical in performance and function to the previously used software.
Indications for Use
The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patient-matched orthodontic appliances.
Comparison to Primary Predicate and Reference Device
The LightForce Orthodontic System in the primary predicate (K183542) 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 software updates to the software delivered in the primary predicate.
The LightForce Orthodontic System in the reference predicate (K181271) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
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Note: this current submission (the subject device) is leveraging performance testing such as shear bond strength, torque strength, tensile strength, wire drag force, etc. of the brackets in the reference device, which remain identical in the subject's predicate device, and the subject device. The current submission only differs from the reference device in the software component (Treatment Planning Software / TPS) which has changed. The changes are described and documented in this submission.
Non-clinical Performance Testing
Validation testing of the TPS was performed in accordance with LFO's design control activities for software and to the software's Test Plan. Validation results, Table 6-1, show that the version of the TPS tested performed equivalent to the software component of the primary predicate (K183542).
| Table 6-1 - LFO System TPS Performance Testing | ||||
|---|---|---|---|---|
| LFO System(K181271) | LFO System TPS3.1(K183542) | LFO System TPS4.0 (currentsubmission) | Equivalence Result | |
| 4.1 Diagnosis -viewing of patient'sdigital impression | 4.1 Diagnosis -viewing of patient'sdigital impression | 4.1 Diagnosis -viewing of patient'sdigital impression | Equivalent (TestReport) | |
| 4.1 Diagnosis -successful diagnosisof patient'smalocclusion | 4.1 Diagnosis -successful diagnosisof patient'smalocclusion | 4.1 Diagnosis -successful diagnosisof patient'smalocclusion | Equivalent (TestReport) | |
| 4.2 Planning -successful movementof patient's teeth(within the software) | 4.2 Planning -successful movementof patient's teeth(within the software) | 4.2 Planning -successful movementof patient's teeth(within the software) | Equivalent (TestReport) | |
| 4.3 Planning -successful movementof brackets | 4.3 Planning -successful movementof brackets | 4.3 Planning -successful movementof brackets | Equivalent (TestReport) | |
| 4.4 Data Handling -case deliveredsecurely anduncorrupted | 4.4 Data Handling -case deliveredsecurely anduncorrupted | 4.4 Data Handling -case deliveredsecurely anduncorrupted | Equivalent (TestReport) |
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Clinical Performance Testing
No clinical performance testing was conducted on LFO System brackets.
Device Comparison Tables
The following tables, Table 6-2 and 6-3, provide a comparison of the device features, functions, and performance characteristics between the LightForce Orthodontic System (LFO System) and its predicate devices.
| Table 6-2 - LFO System TPS Feature Comparison | |||||
|---|---|---|---|---|---|
| WorkflowFunction | LFO System(K181271) | LFO System v3.1(K183542) | LFO System v4.0(currentsubmission) | Similarities | Differences |
| Indicationsfor Use | The LightForceOrthodonticSystem (K183542)is a treatmentplanning softwareand orthodonticappliance systemused to correctmalocclusions inorthodonticpatients usingpatient-matchedorthodonticappliances. | The LightForceOrthodonticSystem (K183542)is a treatmentplanning softwareand orthodonticappliance systemused to correctmalocclusions inorthodonticpatients usingpatient-matchedorthodonticappliances. | The LightForceOrthodonticSystem is atreatment planningsoftware andorthodonticappliance systemused to correctmalocclusions inorthodonticpatients usingpatient-matchedorthodonticappliances. | Identical | |
| 4.1 Diagnosis- viewingpatient'sdigitalimpression | Rendering ofimpression using3D files | Rendering ofimpression using3D files | Rendering ofimpression using3D files | Identical | |
| 4.1 Diagnosis- viewingpatient'sdigital | Rotate impressiondisplay | Rotate impressiondisplay | Rotate impressiondisplay | Identical | |
| impression | |||||
| 4.1 Diagnosis- viewingpatient'sdigitalimpression | Zoom impressiondisplay | Zoom impressiondisplay | Zoom impressiondisplay | Identical | |
| 4.1 Diagnosis- viewingpatient'sdigitalimpression | Pan impressiondisplay | Pan impressiondisplay | Pan impressiondisplay | Identical | |
| 4.1 Diagnosis- successfuldiagnosis ofpatient'smalocclusion | Hide/Showindividual arches | Hide/Showindividual arches | Hide/Showindividual arches | Identical | |
| 4.2 Planning -move teethbased ondesired finallocation | Rotate & translatearound tooth X,Y,Z | Rotate & translatearound tooth X,Y,Z | Rotate & translatearound tooth X,Y,Zas well as Jaw andTMJ axis | Improvedmovementaccuracybymovingarounddesiredaxis. | |
| 4.3 Planning -movebracketsbased ondesired finallocation | Move bracketscontrols | Move bracketscontrols | Move bracketscontrols | Identical | |
| 4.4 DataHandling -case datadeliveredsecurely anduncorrupted | Impression datatransmitted overHTTPS | Impression datatransmitted overHTTPS | Impression datatransmitted overHTTPS | Identical |
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| Table 6-3 - Device Comparison | ||||
|---|---|---|---|---|
| Item | Reference PredicateK181271 LightForceOrthodontic System; | Primary PredicateK183542 LightForceOrthodontic System;TPS 3.1 | LightForceOrthodontic System;TPS 4.0 | Comments |
| Description | The LightForceOrthodontic System(LFO System) is atreatment planningsoftware (TPS) andorthodontic appliancesystem used to correctmalocclusions inorthodontic patientsusing patient-matchedorthodontic appliances.The SO Systemconsists ofpatient-specific ceramicbrackets, patient-specific bracketplacement jigs, archwire templates, and aTPS for viewing,measuring, andmodifying cases.LightForceOrthodontics' (SO)operators and theorthodontists use theTPS to generate aprescription of theirchoosing. SO thenmanufactures thepatient-specificbrackets and placementjigs using proprietaryadditive manufacturingtechniques. Theorthodontist then bondsthe brackets to theteeth using the optionalplacement jig andligates wires to enable | The LightForceOrthodontic System(LFO System) is atreatment planningsoftware (TPS) andorthodontic appliancesystem used to correctmalocclusions inorthodontic patientsusing patient-matchedorthodontic appliances.The SO Systemconsists ofpatient-specific ceramicbrackets, patient-specific bracketplacement jigs, archwire templates, and aTPS for viewing,measuring, andmodifying cases.LightForceOrthodontics' (SO)operators and theorthodontists use theTPS to generate aprescription of theirchoosing. SO thenmanufactures thepatient-specific bracketsand placement jigsusing proprietaryadditive manufacturingtechniques. Theorthodontist then bondsthe brackets to the teethusing the optionalplacement jig andligates wires to enable | The LightForceOrthodontic System(LFO System) is atreatment planningsoftware (TPS) andorthodontic appliancesystem used to correctmalocclusions inorthodontic patientsusing patient-matchedorthodontic appliances.The SO Systemconsists ofpatient-specific ceramicbrackets, patient-specific bracketplacement jigs, archwire templates, and aTPS for viewing,measuring, andmodifying cases.LightForceOrthodontics' (SO)operators and theorthodontists use theTPS to generate aprescription of theirchoosing. SO thenmanufactures thepatient-specific bracketsand placement jigsusing proprietaryadditive manufacturingtechniques. Theorthodontist then bondsthe brackets to the teethusing the optionalplacement jig andligates wires to enable | Identical |
| tooth movement. The SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth. | tooth movement. The SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth. | tooth movement. The SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth. | ||
| Product Codes /Regulations | NJM (Orthodontic Ceramic Bracket, 21CFR§872.5470) | NJM (Orthodontic Ceramic Bracket, 21CFR§872.5470) | NJM (Orthodontic Ceramic Bracket, 21CFR§872.5470) | Identical |
| Indications for Use | 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. | 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. | 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. | Identical |
| Sequence of Treatment Plan or Mode of Use | LightForce Orthodontics (LFO) receives the patient's digital data via commercially available communications tools from the DDS/DMD. LFO prepares a final tooth setup and bracket placement plan and returns the digital data back to the DDS/DMD. The orthodontist can then view, measure and modify the case using the TPS. Once approved, brackets and jigs are manufactured and shipped to the DDS/DMD. | LightForce Orthodontics (LFO) receives the patient's digital data via commercially available communications tools from the DDS/DMD. LFO prepares a final tooth setup and bracket placement plan and returns the digital data back to the DDS/DMD. The orthodontist can then view, measure and modify the case using the TPS. Once approved, brackets and jigs are manufactured and shipped to the DDS/DMD. | LightForce Orthodontics (LFO) receives the patient's digital data via commercially available communications tools from the DDS/DMD. LFO prepares a final tooth setup and bracket placement plan and returns the digital data back to the DDS/DMD. The orthodontist can then view, measure and modify the case using the TPS. Once approved, brackets and jigs are manufactured and shipped to the DDS/DMD. | Identical |
| ManufacturingMethod | Final desiredarrangement of teeth,brackets, wires and jigsare designed with theguidance of LFOinternal computersoftware using a 3-Dmodel of the patient.The TreatmentPlanning Softwareallows the clinician toreview, measure, andmodify the case.Internal LFO softwaregenerates the 3Dimage file thatproprietary additivemanufacturingequipment uses tocreate the brackets andindirect bonding (IDB)tray. | Final desiredarrangement of teeth,brackets, wires and jigsare designed with theguidance of LFOinternal computersoftware using a 3-Dmodel of the patient.The Treatment PlanningSoftware allows theclinician to review,measure, and modifythe case. Internal LFOsoftware generates the3D image file thatproprietary additivemanufacturingequipment uses tocreate the brackets andindirect bonding (IDB)tray. | Final desiredarrangement of teeth,brackets, wires and jigsare designed with theguidance of LFOinternal computersoftware using a 3-Dmodel of the patient.The Treatment PlanningSoftware allows theclinician to review,measure, and modifythe case. Internal LFOsoftware generates the3D image file thatproprietary additivemanufacturingequipment uses tocreate the brackets andindirect bonding (IDB)tray. | Identical |
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Conclusion
The LightForce Orthodontics' LightForce Orthodontics System presented in this 510(k) submission and its primary predicate the LightForce Orthodontic System (K183542) and its reference predicate the LightForce Orthodontics System (K181271) are substantially equivalent in intended use and technological characteristics.
§ 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.