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.

Device Description

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.

AI/ML Overview

The document provided focuses on the substantial equivalence of the "Signature Orthodontic System" to predicate devices, primarily through non-clinical performance testing. It does not contain information about a study proving the device meets acceptance criteria in the way this request is typically framed for AI/algorithm performance (e.g., sensitivity, specificity, or reader study metrics).

Instead, the provided text describes bench testing to demonstrate performance equivalence of orthodontic brackets, which is a different type of "acceptance criteria" and "study."

Here's an analysis based on the provided text, addressing the points where information is available or noting where it is not:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)

Acceptance Criteria (Measured Performance Aspect)	Reported Device Performance (Signature Orthodontic System)	Related Predicate Device Performance	Conclusion (Signature Orthodontic System vs. Predicate)
Shear Bond Strength	Higher average value	Lower average value	Equivalent to or better than predicate
Torque Strength	Slightly higher average value	Slightly lower average value	Equivalent to predicate (no statistically significant difference)
Friction (Wire Drag) Force	Slightly lower average value	Slightly higher average value	Equivalent to predicate (no statistically significant difference)
Tensile Bond Strength	Higher average value	Lower average value	Equivalent to or better than predicate
Tie-wing Tensile Fracture Strength	Slightly lower average value	Slightly higher average value	Equivalent to predicate (no statistically significant difference)
ISO 27020 Compliance	Evaluated for compliance	N/A	Compliant
Biocompatibility (ISO 10993-1)	Evaluated for biocompatibility	N/A	Biocompatible (based on risk assessment and specific tests: genotoxicity, cytotoxicity (agarose and elution), sensitization, oral toxicity, irritation, chemical characterization)

Note: The above criteria are for the physical properties and biocompatibility of the orthodontic brackets, not for the performance of a software algorithm in terms of diagnostic accuracy or reader improvement.

Additional Information based on the provided text:

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each bench test. The text mentions "average value" and "statistically significant differences," implying multiple units were tested in each category.
- Data Provenance: Not applicable in the context of bench testing for physical devices. The testing was non-clinical.
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)
- Not applicable. The ground truth for bench tests is the physical measurement based on standardized testing procedures, not expert consensus interpreting data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as this refers to human review of diagnostic data.
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 MRMC study was done. The document explicitly states: "No clinical performance testing was conducted on SO System brackets." The "Signature Orthodontic System" includes "treatment planning software," but the performance testing described only relates to the physical brackets.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not described as such. The "treatment planning software" is mentioned as part of the system, but its standalone performance (e.g., accuracy of treatment planning suggestions) is not detailed or evaluated in the provided performance data. The performance section focuses exclusively on the physical brackets.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Test Measurements: The "ground truth" for the physical bracket tests would be the direct measurements obtained using calibrated instrumentation according to standardized test methods (e.g., for shear bond strength, torque strength, tensile strength, friction, and fracture strength). For biocompatibility, it's compliance with ISO 10993-1.
The sample size for the training set
- Not applicable. This device is a physical orthodontic system and associated software, not an AI model requiring a training set in the typical sense of machine learning. The software aids in treatment planning but is not described as a learning algorithm that undergoes "training."
How the ground truth for the training set was established
- Not applicable, as there is no "training set" for an AI algorithm described in this context.

Summary

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Signature Orthodontics % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K181271

Trade/Device Name: Signature Orthodontic System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NJM Dated: May 11, 2018 Received: May 14, 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. 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 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); good

June 13, 2018

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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,

Mary S. Runner -S

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) K181271

Device Name Signature Orthodontic System

Indications for Use (Describe)

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.

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 (K181271)

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Signature Orthodontics 16 Miner Street, Suite 406 Boston, MA 02215

Phone: 540-229-1236 Facsimile: N/A Email: alfred@soiboston.com

Contact Person: Alfred Charles Griffin III

Date Prepared: June 13, 2018

Name of Device and Name/Address of Sponsor

Signature Orthodontic System

Signature Orthodontics 16 Miner Street, Suite 406 Boston, MA 02215

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: TOMY Orthodontic Ceramic Brackets 1.1 (K160615)

Reference Predicate: Insignia Digicast (K123118)

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Device Description

Intended Use / Indications for Use

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

The differences in the SO System indication for use from its predicates does not affect the equivalence of the devices when used as labeled. The treatment planning software refers to the computer aided system which aids orthodontic diagnostics and treatment within the Insignia Digicast indication. The patient-matched orthodontic appliances and correction of malocclusions relate to the ceramic brackets and orthodontic movement discussed in the TOMY indication. The patient-matched brackets do not raise any levels of concern or efficacy as shown through the substantially equivalent performance tests completed between the SO System brackets and the TOMY brackets.

Technological Characteristics

Signature Orthodontic System is substantially equivalent to two other legally marketed devices. The TPS has similar functionally and intended for the same use as Insignia Digicast (K123118) while the patient-specific ceramic brackets are equivalent to the TOMY Orthodontic Ceramic Brackets 1.1 (K160615). Table 6-1 provides a comparison of the SO System to the predicate devices.

The SO System patient-specific brackets, like its predicate TOMY Orthodontic Ceramic Brackets 1.1, 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 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 substantially equivalent to the SO System predicate, TOMY Orthodontic Ceramic Brackets 1.1. Performance testing consisted of shear bond strength and torque strength. Tensile testing and bracket strength (fracture) testing were also completed as comparison tests.

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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 SO System brackets is equivalent to or better than the predicate device because the average value of the SO System brackets' shear bond strength was statistically significantly higher than that of 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 SO System brackets is equivalent to the predicate device because there were no statistically significant differences between the two groups. The average value of the SO System brackets' torque strength was slightly higher than that of the predicate device.
1. Friction (wire drag) 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 SO System brackets is equivalent to the predicate device because there were no statistically significant differences between the two groups. The average value of the SO System brackets' friction (wire drag) force was slightly lower than that of 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 SO System brackets is equivalent to or better than the predicate device because the average value of the SO System brackets' tensile bond strength was statistically significantly higher than that of 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 tensile fracture strength of SO System brackets is equivalent to the predicate device because there were no statistically significant differences between the two groups. The average value of the SO System brackets' tie wing fracture strength was slightly lower than that of the predicate device.

Due to the different methods of manufacturing from its predicate, the SO System brackets were evaluated for ISO 27020: "Dentistry - Brackets and Tubes for Use in Orthodontics" compliance and biocompatibility using standard risk assessment techniques and guidelines according to ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process". Biocompatibility testing performed included genotoxicity, cytotoxicity (agarose and elution methods), sensitization, oral toxicity, irritation, and chemical characterization.

Clinical Performance Testing

No clinical performance testing was conducted on SO System brackets.

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Traditional 510(k) Tab 6 — 510(k) Summary

Table 6-1: Comparison of SO System and Predicates
ITEM	Primary PREDICATE K160615TOMY Orthodontic CeramicBrackets 1.1	Reference PREDICATEK123118 Digital Study Model(Insignia Digicast)	Signature Orthodontic System
Description	Orthodontic Ceramic Brackets1.1 are designed to move teethto improve their alignment.Orthodontic Ceramic Brackets1.1 are bonded to natural teethby dental professionals toconnect with orthodontic wiresto cause tooth movement to amore preferred position.	Insignia Digicast is a softwareproduct and service that createsdigital models of patients' teeth,which are used primarily to recordthe status of a patients' dentitionprior to treatment. Clinicians mayalso use the digital model tosupport their diagnosis. TheInsignia Digicast system scans atraditional impression, processesthe scan, and electronically deliversa digital study model to the dentalprofessional. The dentalprofessional may view, measure,and analyze the study model usingthe Insignia Digicast three-dimensional viewer software. Themain analysis tools include TJMoyers, Bolton analyses, ABOscoring, and Arch andOverbite/Overjet measurements.There are no accessories or patientcontacting components of InsigniaDigicast.	The Signature Orthodontic System (SOSystem) is a treatment planning software(TPS) and orthodontic appliance systemused to correct malocclusions inorthodontic patients using patient-matched orthodontic appliances. The SOSystem consists of patient-specificceramic brackets, patient-specific bracketplacement jigs, arch wire templates, anda TPS for viewing, measuring, andmodifying cases. Signature Orthodontics'(SO) operators and the orthodontists usethe TPS to generate a prescription oftheir choosing. SO then manufacturesthe patient-specific brackets andplacement jigs using proprietary additivemanufacturing techniques. Theorthodontist then bonds the brackets tothe teeth using the optional placement jigand ligates wires to enable toothmovement. The SO System does notcontain commercially-available or patient-specific shaped arch wires, ligatures, oradhesives that affixes the brackets to theteeth.
ProductCodes/Regulations	NJM (Orthodontic CeramicBracket, 21CFR§872.5470)	DYW (Orthodontic Plastic Bracket,21CFR§872.5470)EJF (Orthodontic Metal Bracket,21CFR§872.5410)	NJM (Orthodontic Ceramic Bracket,21CFR§872.5470)
		NJM (Orthodontic Ceramic Bracket,21CFR§872.5470)
Indications for Use	Orthodontic Ceramic Brackets1.1 are indicated for orthodonticmovement of natural teeth.	Insignia Digicast is a computeraided system intended for use asan aid in orthodontic diagnostics foruse by dental professionals trainedin orthodontic treatment includingradiographic analyses anddiagnostics.	The Signature Orthodontic System is atreatment planning software andorthodontic appliance system used tocorrect malocclusions in orthodonticpatients using patient-matchedorthodontic appliances.
Sequence ofTreatment Plan orMode of Use	The Orthodontic CeramicBrackets 1.1 are bonded tonatural teeth by dentalprofessionals to connect withorthodontic wires to cause toothmovement to a more preferredposition.	Scans a traditional impression,processes the scan, andelectronically delivers a digital studymodel to the dental professional	Signature Orthodontics (SO) receives thepatient's digital data via commerciallyavailable communications tools from theDDS/DMD. SO prepares a final toothsetup and bracket placement plan andreturns the digital data back to theDDS/DMD. The orthodontist can thenview, measure and modify the case usingthe TPS. Once approved, brackets andjigs are manufactured and shipped to theDDS/DMD.
Bracket Material	Polycrystalline AluminaCeramic	N/A	Polycrystalline Alumina Ceramic
ManufacturingMethod	Ceramic Injection Molded	A orthodontal professional takes animpression of the patient's teeth byalginate or PVS. The impression isscanned and converted to a digitalmodel. This model is thenuploaded for use by thepractitioner.	Final desired arrangement of teeth,brackets, wires and jigs are designedwith the guidance of SO internalcomputer software using a 3-D model ofthe patient. The Treatment PlanningSoftware allows the clinician to review,measure, and modify the case. InternalSO software generates the 3D image filethat proprietary additive manufacturing
			equipment uses to create the bracketsand indirect bonding (IDB) tray.
Analysis Methods	N/A	Bolton analysis, Tanaka-JohnsonMoyers Analysis, Space Analysis,and ABO Discrepancy IndexScoring	N/A
Non-sterile, singleuse	Yes	N/A	Yes
Bracket Base	Mechanical Lock Base	N/A	Mechanical Lock Base
Bracket Design	Arch wire slot, tie wings forligature, and identificationmarks for placement. Hooks forligation, for additional toothmovement. Molded ceramicbody with rounded corners andedges. Slot to hold orthodonticwires. Non-self-ligating andself-ligating	N/A	Arch wire slot, tie wings for ligature, andidentification marks for placement. Hooksfor ligation, for additional toothmovement. Printed ceramic body withrounded corners and edges. Slot to holdorthodontic wires. Non-self-ligating

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Substantial Equivalence

The Signature Orthodontic System) is substantially equivalent to the predicate devices; Insignia Digicast, and TOMY Orthodontic Ceramic Brackets 1.1. The SO 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 SO System performs at an equivalent or better level compared to Insignia Digicast, and TOMY Orthodontic Ceramic Brackets 1.1. The minor technological differences between the SO System and the predicate devices, Insignia Digicast, and TOMY Orthodontic Ceramic Brackets 1.1, raise no new issues. There are no alterations in the intended use or the underlying technology or science involved. Thus, the Signature Orthodontic System is substantially equivalent to its predicates.

Conclusion

The difference between the SO System and its predicates is the manufacturing method. Additionally, the SO 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 SO 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.

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)

Additional Information based on the provided text:

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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TAB 6

510K SUMMARY

510(k) SUMMARY

Signature Orthodontics' Signature Orthodontic System (K181271)

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Name of Device and Name/Address of Sponsor

Device Description

Intended Use / Indications for Use

Technological Characteristics

Non-clinical Performance Testing

Clinical Performance Testing

Traditional 510(k) Tab 6 — 510(k) Summary

Substantial Equivalence

Conclusion

§ 872.5470 Orthodontic plastic bracket.

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