Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

Device Description

Insignia Digicast is a software product and service that creates digital models of patients' teeth, which are used primarily to record the status of a patients' dentition prior to treatment. Clinicians may also use the digital model to support their diagnosis. The Insignia Digicast system scans a traditional impression, processes the scan, and electronically delivers a digital study model to the dental professional. The dental professional may view, measure, and analyze the Insignin Digicast three dimensional viewer software. The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements. There are no accessories or patient contacting components of Insignia Digicast.

AI/ML Overview

The provided document describes the Insignia Digicast, a software product and service that creates digital models of patients' teeth for orthodontic diagnostics.

Here's an analysis of the acceptance criteria and study data:

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy thresholds for measurements). Instead, it relies on demonstrating substantial equivalence to predicate devices (OrthoCAD iQ and Lava Digital Models) through qualitative comparisons of features and mode of use, and quantitative comparisons of measurement accuracy.

Feature/Measurement	Acceptance Criteria (Implied by Substantial Equivalence)	Insignia Digicast Performance (Reported)
Teeth Width	Functionally equivalent to predicates	Bench tested, successfully validated
Space	Functionally equivalent to predicates	Bench tested, successfully validated
T-J Moyers Analysis	Functionally equivalent to predicates	Bench tested, successfully validated
Bolton Analysis	Functionally equivalent to predicates	Bench tested, successfully validated
Arch Measurements	Functionally equivalent to predicates	Bench tested, successfully validated
Overbite/Overjet	Functionally equivalent to predicates	Bench tested, successfully validated
Overall Performance	Substantially equivalent to predicate devices	Deemed substantially equivalent

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided document. The document states "data from bench testing" was used, but does not quantify the number of cases or models tested.
- Data Provenance: Not explicitly stated. Given it's bench testing, it's likely synthetic data, cadaver models, or a collection of patient impressions, but the origin (e.g., country) is not mentioned. It is a retrospective evaluation against existing (presumably traditional) measurements.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not specified. The document indicates that bench testing was used to "evaluate the performance characteristics... compared to the predicate device." It doesn't mention expert involvement in establishing a separate ground truth for the test set beyond the comparisons made with the predicate device's established performance.
Adjudication Method for the Test Set:
- Not specified. This information is typically relevant for human-reader evaluations, which did not occur for this device.
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 comparative effectiveness study was done. The document explicitly states: "Clinical testing has not been conducted on this product."
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone evaluation was performed. The "Non-Clinical Performance Data" section describes "bench testing" to evaluate the "performance characteristics of Insignia Digicast," which is an algorithm-only assessment. The software was "successfully validated to confirm the performance of the device."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical performance evaluation was based on comparisons to the predicate device, OrthoCAD iQ, for characteristics such as teeth width, space, and various analyses (T-J Moyers, Bolton, Arch, Overbite/Overjet). This implies the predicate device's measurements served as the reference or accepted standard.
The sample size for the training set:
- Not specified. The document does not provide any details regarding the training data or its size.
How the ground truth for the training set was established:
- Not specified. Since no information on the training set is provided, the method for establishing its ground truth is also unknown.

Summary

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K123118

Image /page/0/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo consists of the letters "sds" in a bold, sans-serif font, with a curved line above the letters. Below the letters, the words "Sybron Dental Specialties" are written in a smaller, sans-serif font. The logo is simple and modern, and the use of bold fonts makes it easily recognizable.

MAR 2 6 2013

510K SUMMARY

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: March 2013

. Trade name - Insignia Digicast
Common name -Digital Study Model
Classification name Orthodontic Plastic Bracket (21 CFR§872.5470) .
- Product Codes DYW (Orthodontic Plastic Bracket)
  - (Orthodontic Metal Bracket) EJF
  - NJM (Orthodontic Ceramic Bracket)

Device for Which Substantial Equivalence is Claimed:

. Lava Digital Models, Marketed by 3M Unitek Class | Exempt Product Code: LMD (21CFR§892.2020)
OrthoCAD iQ, Marketed by Cadent, Inc. ● Class II Study model described within K082207 DYW (Orthodontic Plastic Bracket, 21CFR§872.5470) Product Code: EJF (Orthodontic Metal Bracket, 21CFR§872.5410) NJM (Orthodontic Ceramic Bracket, 21CFR§872.5470)

Summary

Device Description

Insignia Digicast is a software product and service that creates digital models of patients' teeth, which are used primarily to record the status of a patients' dentition prior to treatment.

Clinicians may also use the digital model to support their diagnosis. The Insignia Digicast system scans a traditional impression, processes the scan, and electronically delivers a digital study model to the dental professional.

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KI 23118

The dental professional may view, measure, and analyze the Insignin Digicast three dimensional viewer software. The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements.

There are no accessories or patient contacting components of Insignia Digicast.

Indications for Use of the Device

Technological Characteristics Compared to Predicate

Features	Insignia Digicast	OrthoCAD iQ	Lava Digital Model
	Insignia Digicast is a computeraided system intended for useas an aid in orthodonticdiagnostics for use by dentalprofessionals trained inorthodontic treatmentincluding radiographic analysesand diagnostics.	Ortho CAD iQ is acomputer-guided systemintended for use as an aidin orthodontic treatmentplanning for use by dentalprofessionals trained inorthodontic treatmentincluding radiographicanalyses and treatmentplanning. OrthoCAD iQ isintended for use withcommercially-availablebrackets and wires thatapply continuous gentleforce to reposition theteeth. It also uses indirectbonding trays to affix thebrackets in position.	Lava Digital Models isa software productthat allows cliniciansto display and interactwith digital studymodels for patientconsultations. LavaDigital Models scans atraditional impression,processes the scanand electronicallydelivers the digitalstudy model to thedental professional.The dentalprofessional mayview, measure andanalyze the digitalstudy model.
Indications forUse
Features (cont.)	Insignia Digicast	OrthoCAD iQ	Lava Digital Model
Mode of Use	The Insignia Digicast systemscans a traditional impression,processes the scan, andelectronically delivers a digitalstudy model to the dentalprofessional.	The OrthoCAD iQ systemscans a traditionalimpression, processes thescan, and electronicallydelivers a digital studymodel to the dentalprofessional.	The Lava DigitalModels system scansa traditionalimpression, processesthe scan, andelectronically deliversa digital study modelto the dentalprofessional.
	ManufacturingMethod	A dental professional takes analginate or PVS impression ofthe patient's teeth. Theimpression is then scanned andconverted into a digital model.This model is then uploaded foruse by the practitioner.	A dental professionaltakes an alginate or PVSimpression of thepatient's teeth Theimpression is thenscanned and convertedinto a digital model. Thismodel is then uploadedfor use by thepractitioner.	A dental professionaltakes an alginate orPVS impression of thepatient's teeth Theimpression is thenscanned andconverted into adigital model. Thismodel is thenuploaded for use bythe practitioner.
		AnalysesAvailable	The following analyses areavailable for use by the dentalpractitioner: Bolton Analysis,Tanaka-Johnston/MoyersAnalysis, Space Analysis, andABO Discrepancy Index Scoring.	The following analyses areavailable for use by thedental practitioner:Bolton Analysis, Tanaka-Johnston/MoyersAnalysis, Space Analysis,and ABO DiscrepancyIndex Scoring	Instantly obtain point-to-pointmeasurements withautomatic calculationsand auto-sums(Bolton analysis, archlength, overbite andoverjet)

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Non-Clinical Performance Data

This 510(k) submission includes data from bench testing used to evaluate the performance characteristics of Insignia Digicast compared to the predicate device, OrthoCAD iQ. The characteristics evaluated include, but were not limited to, teeth width, space, T-J Moyers, Bolton, Arch and Overbite/Overjet.

The Insignia Digicast software has been successfully validated to confirm the performance of the device.

Clinical Testing

Clinical testing has not been conducted on this product.

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Conclusion

Based upon the similar technological/performance characteristics as compared to the predicate devices, and successful validation of the Insignia Digicast software, the performance of the Insignia Digicast is deemed to be substantially equivalent to the OrthoCAD iQ and Lava Digital Models. Additionally, there are no functional differences between the devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 26, 2013

Ormeo Corporation C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties 1717 West Collins Avenue ORANGE CA 92867

Re: K123118

Trade/Device Name: INSIGNIA DIGICAST Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW, NJM, EJF Dated: February 22, 2013 Received: February 25, 2013

Dear Ms. Garman:

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.

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Page 2 - Ms. Garman

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer -S
for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K123118

Indications for Use

510(k) Number (if known):

Device Name: INSIGNIA DIGICAST

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Andrew I. Steen Concurrence of Collige of Concerner ation (ODE)

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K123118 510(k) Number:

004_Indications for Use - Page 2 of 2

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.