(13 days)
The Signature Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
The Signature Orthodontic System (SO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patientmatched orthodontic appliances. The SO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, and modifying cases. Signature Orthodontics' (SO) operators and the orthodontists use the TPS to generate a prescription of their choosing. SO 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 SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.
The provided document is a 510(k) summary for the Signature Orthodontic System, specifically focusing on a software change (replacement of Meshmixer 3.4 with Treatment Planning 3.1). Based on the information presented, here's an analysis of the acceptance criteria and the study proving the device meets them:
Overall Conclusion from the Document:
The document states that the new software component (Treatment Planning 3.1) performs "equivalent" to the previous off-the-shelf software (Meshmixer 3.4) and that the product's indications for use, product codes/regulations, sequence of treatment plan, and manufacturing method are "identical" to the predicate device. The core of the equivalence claim rests on non-clinical performance testing of the software itself. It explicitly states "No clinical performance testing was conducted."
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the demonstration of "equivalence" to the predicate device's software function. The performance is reported as "Equivalent" for all tested functions.
| Function/Workflow | Predicate Device Performance (Meshmixer 3.4) | New Device Performance (TPS 3.1) | Acceptance Criteria Met? |
|---|---|---|---|
| 4.1 Diagnosis - viewing patient's digital impression | Rendering of impression using triangle meshes read from STL files | Rendering of impression using triangle meshes read from STL files | Equivalent (Test Report) |
| 4.1 Diagnosis - successful diagnosis of patient's malocclusion | Hide/show individual arches (requires multiple clicks) | Hide/show individual arches (single click) | Equivalent (Test Report) |
| 4.4 Data Handling - case data delivered securely and un-corrupted | Secure link used to download STL files, then File -> Open in device. | Open secure link in web browser (removes download STL files step) | Equivalent (Test Report) |
| 4.1 Diagnosis - viewing and measuring patient's digital impression | Rotate impression display | Rotate impression display | Equivalent (Test Report) |
| 4.1 Diagnosis - viewing and measuring patient's digital impression | Pan impression display | Pan impression display | Equivalent (Test Report) |
| 4.1 Diagnosis - viewing and measuring patient's digital impression | Zoom impression display | Zoom impression display | Equivalent (Test Report) |
| 4.1 Diagnosis - viewing and measuring patient's digital impression | Point-to-point measurement | N/A (not included in TPS 3.1 requirements specification) | (No direct comparison, but overall equivalence claimed based on other features) |
Note on "Point-to-point measurement": While TPS 3.1 does not include this feature, the overall claim is "equivalence" based on the other listed functions. The rationale for this difference not affecting equivalence is not explicitly detailed but might be because it's considered a minor functional change that doesn't impact the core safety and effectiveness of the device for its stated indications for use, or that other remaining features are sufficient.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of patient data or number of cases for the performance testing. The validation testing was performed "in accordance with SO's design control activities for software and to the software's Test Plan." This suggests software validation processes (e.g., unit testing, integration testing, system testing) rather than a clinical study with a patient cohort.
- Data Provenance: Not applicable, as this was non-clinical software performance testing against functional requirements, not testing with patient data.
- Retrospective/Prospective: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This testing was software performance validation, comparing the functionality of the new software to the old software, not a study requiring expert clinical interpretations or ground truth establishment based on medical images.
4. Adjudication Method for the Test Set
Not applicable. This was software performance validation against functional specifications, not a study requiring adjudication of expert readings.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "No clinical performance testing was conducted on SO System brackets." This implies no human reader studies (with or without AI assistance) were performed. The FDA clearance is based on the substantial equivalence of the software component for its functional performance, not on demonstrating improved human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No. The testing was functional validation of the software itself, akin to software quality assurance (QA) and verification/validation (V&V) activities. It was not a "standalone performance" study in the sense of evaluating an AI algorithm's diagnostic accuracy against a ground truth on a large set of real-world patient data in an isolated fashion. The software (Treatment Planning 3.1) is a tool within a larger system used by human operators and orthodontists.
7. The Type of Ground Truth Used
For the non-clinical performance testing of the software, the "ground truth" was the functional requirements and expected outputs based on the performance of the predicate software (Meshmixer 3.4). The testing aimed to show that the new software performed "equivalent" functions to the previously cleared predicate software.
8. The Sample Size for the Training Set
Not applicable. The document describes a replacement software that was "developed by SO exclusively," implying it's a rule-based or deterministic software, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set for a machine learning model was used.
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Signature Orthodontics % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313
Re: K183542
Trade/Device Name: Signature Orthodontic System Regulation Number: 21 CFR Orthodontic Plastic Bracket Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: December 17, 2018 Received: December 20, 2018
Dear Mark Job:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
January 2, 2019
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Marv S. Mary S. Runner -S3 Runner -S3 Date: 2019.01.02
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Signature Orthodontic System
Indications for Use (Describe)
The Signature Orthodontic System is a treatment planning software and orthodonic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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TAB 6
510K SUMMARY
510(k) SUMMARY
Signature Orthodontics' Signature Orthodontic System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Signature Orthodontics 1035 Cambridge Street Cambridge, MA 02141
Phone: 540-229-1236 Facsimile: N/A Email: alfred@soiboston.com
Contact Person: Alfred Charles Griffin III
Date Prepared: November 13, 2018
Name of Device and Name/Address of Sponsor
Signature Orthodontic System
Signature Orthodontics 1035 Cambridge Street Cambridge, MA 02141
Trade/Proprietary Name of Device: Signature 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)
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Device Description and Justification
The Signature Orthodontic System (SO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patientmatched orthodontic appliances. The SO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, and modifying cases. Signature Orthodontics' (SO) operators and the orthodontists use the TPS to generate a prescription of their choosing. SO 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 SO 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 replace Meshmixer 3.4 as the software component of the SO System with Treatment Planning 3.1 The software component of the SO System was originally cleared in K181271. Meshmixer is Off-the-Shelf (OTS) Software, the new software has been developed by SO exclusively. The functional requirements of the software component are unchanged. A comparison of Treatment Planning 3.1 and Meshmixer 3.4 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.
Intended Use / Indications for Use
The indications for use are the same between this submission and the primary predicate K181271.
The Signature Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patient-matched orthodontic appliances.
The Signature Orthodontic System (K181271) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patient-matched orthodontic appliances.
Non-clinical Performance Testing
Validation testing of the TPS was performed in accordance with SO'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 (K181271).
| Primary PREDICATE K181271Signature Orthodontic System;TPS Off-the-shelf | Signature Orthodontic System;TPS 3.1 | Equivalence Result |
|---|---|---|
| 4.1 Diagnosis - viewing patient'sdigital impression | 4.1 Diagnosis - viewing patient'sdigital impression | Equivalent (TestReport) |
| 4.1 Diagnosis - successful diagnosisof patient's malocclusion | 4.1 Diagnosis - successful diagnosisof patient's malocclusion | Equivalent (TestReport) |
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| 4.4 Data Handling - case datadelivered securely and un-corrupted | 4.4 Data Handling - case datadelivered securely and un-corrupted | Equivalent (TestReport) |
|---|---|---|
| 4.1 Diagnosis - viewing andmeasuring patient's digital impression | 4.1 Diagnosis - viewing andmeasuring patient's digital impression | Equivalent (TestReport) |
Clinical Performance Testing
No clinical performance testing was conducted on SO System brackets.
Device Comparison Tables
The following tables, Tables 6-2 and 6-3, provide a comparison of the device features, functions, and performance characteristics between the Signature Orthodontic System and its predicate devices.
| Table 6-2 - SO System TPS Feature Comparison | ||||
|---|---|---|---|---|
| WorkflowFunction | SO System TPS -Off-the-shelf | SO System TPS -TPS 3.1 | Similarities | Differences |
| 4.1 Diagnosis -viewing patient'sdigitalimpression | Rendering ofimpression usingtriangle meshesread from STLfiles | Rendering ofimpression usingtriangle meshesread from STLfiles | Identical | |
| 4.1 Diagnosis -successfuldiagnosis ofpatient'smalocclusion | Hide/showindividual arches | Hide/showindividual arches | Identical | TPS 3.1 enableshide/show archeswith a singleclick. OTSrequires multipleclicks. |
| 4.4 DataHandling - casedata deliveredsecurely and un-corrupted | Secure link usedto download STLfiles, then File ->Open in device. | Open secure linkin web browser. | Secure linkcommunicatedusing theorthodontist'sconfirmed e-mail addressesImpression datatransmitted overHTTPs | TPS 3.1 removesthe downloadSTL files stepand integratesthe transfer withthe loading of thesoftware by theuser's webbrowser. |
| 4.1 Diagnosis -viewing andmeasuringpatient's digitalimpression | Rotate impressiondisplay | Rotate impressiondisplay | Identical | |
| Pan impressiondisplay | Pan impressiondisplay | Identical | ||
| Zoom impressiondisplay | Zoom impressiondisplay | Identical |
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| Point-to-pointmeasurement | N/A | The requirementsspecification forTPS 3.1 does notinclude point-to-pointmeasurement. | |
|---|---|---|---|
| -- | ------------------------------- | ----- | --------------------------------------------------------------------------------------------------------- |
| Table 6-3 - Device Comparison | ||||
|---|---|---|---|---|
| ITEM | Primary PREDICATE K181271Signature OrthodonticSystem; TPS Off-the-shelf | Signature OrthodonticSystem; TPS 3.1 | Comments | |
| Description | The Signature OrthodonticSystem (SO System) is atreatment planning software(TPS) and orthodonticappliance system used tocorrect malocclusions inorthodontic patients usingpatient-matched orthodonticappliances. The SO Systemconsists of patient-specificceramic brackets, patient-specific bracket placement jigs,arch wire templates, and a TPSfor viewing, measuring, andmodifying cases. SignatureOrthodontics' (SO) operatorsand the orthodontists use theTPS to generate a prescriptionof their choosing. SO thenmanufactures the patient-specific brackets andplacement jigs using proprietaryadditive manufacturingtechniques. The orthodontistthen bonds the brackets to theteeth using the optionalplacement jig and ligates wiresto enable tooth movement. TheSO System does not containcommercially-available orpatient-specific shaped archwires, ligatures, or adhesivesthat affixes the brackets to theteeth. | The Signature OrthodonticSystem (SO System) is atreatment planning software(TPS) and orthodonticappliance system used tocorrect malocclusions inorthodontic patients usingpatient-matched orthodonticappliances. The SO Systemconsists of patient-specificceramic brackets, patient-specific bracket placementjigs, arch wire templates, anda TPS for viewing,measuring, and modifyingcases. SignatureOrthodontics' (SO) operatorsand the orthodontists use theTPS to generate aprescription of their choosing.SO then manufactures thepatient-specific brackets andplacement jigs usingproprietary additivemanufacturing techniques.The orthodontist then bondsthe brackets to the teethusing the optional placementjig and ligates wires to enabletooth movement. The SOSystem does not containcommercially-available orpatient-specific shaped archwires, ligatures, or adhesivesthat affixes the brackets tothe teeth. | Identical | |
| Product Codes/Regulations | NJM (Orthodontic CeramicBracket, 21CFR§872.5470) | NJM (Orthodontic CeramicBracket, 21CFR§872.5470) | Identical | |
| Indications forUse | The Signature OrthodonticSystem is a treatment planningsoftware and orthodonticappliance system used tocorrect malocclusions inorthodontic patients usingpatient-matched orthodonticappliances. | The Signature OrthodonticSystem is a treatmentplanning software andorthodontic appliance systemused to correct malocclusionsin orthodontic patients usingpatient-matched orthodonticappliances. | Identical | |
| Sequence ofTreatment Planor Mode of Use | Signature Orthodontics (SO)receives the patient's digitaldata via commercially availablecommunications tools from theDDS/DMD. SO prepares a finaltooth setup and bracketplacement plan and returns thedigital data back to theDDS/DMD. The orthodontistcan then view, measure andmodify the case using the TPS.Once approved, brackets andjigs are manufactured andshipped to the DDS/DMD. | 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 andshipped to the DDS/DMD. | Identical | |
| ManufacturingMethod | Final desired arrangement ofteeth, brackets, wires and jigsare designed with the guidanceof SO internal computersoftware using a 3-D model ofthe patient. The TreatmentPlanning Software allows theclinician to review, measure,and modify the case. InternalSO software generates the 3Dimage file that proprietaryadditive manufacturingequipment uses to create thebrackets and indirect bonding(IDB) tray. | Final desired arrangement ofteeth, brackets, wires and jigsare designed with theguidance of SO internalcomputer software using a 3-D model of the patient. TheTreatment Planning Softwareallows the clinician to review,measure, and modify thecase. Internal SO softwaregenerates the 3D image filethat proprietary additivemanufacturing equipmentuses to create the bracketsand indirect bonding (IDB)tray. | Identical |
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Conclusion
The Signature Orthodontics' Signature Orthodontic System presented in this 510(k) submission and its predicate the Signature Orthodontic System (K181271) are substantially equivalent in materials, performance and safety 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.