eXceed Computerized Precision Bracket Placement Solution is a software system intended for use as an aid in orthodontic treatment planning to correct Malocclusions in Orthodontic Patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. eXceed Computerized Precision Bracket Placement Solution is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the Dental professional to place multiple brackets at the same time.

Device Description

The device consists of proprietary software that calculates the ideal position of the dental brackets based on the dental impressions and or 3D models supplied by the patients Orthodontist. Commercially available brackets are used as part of the system. Using the images provided by the Dental Professional, the software creates a 3D model and identifies the ideal placement of the brackets. The file is sent to the Dental Professional for review and approval. The Dental Professional may adjust the final position of the bracket if desired. A 3D model is printed, and the brackets are placed on the model in the prescribed location, approved by the Orthodontist. An indirect bonding tray is fabricated with the brackets in place. The tray and brackets are sent to the Dental professional. The Dental Professional places the indirect tray using their chosen commercially available bracket adhesive.

AI/ML Overview

The provided text describes the "eXceed Computerized Precision Bracket Placement Solution" and its substantial equivalence to a predicate device, Ortho CADiQ. However, the document does not contain details about specific acceptance criteria, a detailed study that proves the device meets specific performance metrics, or the other requested information such as sample sizes, expert qualifications, or adjudication methods for performance studies.

The text focuses on demonstrating substantial equivalence based on intended use, technological characteristics, and principles of operation, rather than providing granular performance data from a specific study against predefined acceptance criteria.

The only mention of "Performance Data" is:
"The software is verified and validated by the digital model generated, matching the 3D model and bracket placement locations prescribed and approved by the Orthodontist."

This statement is very general and does not provide quantifiable acceptance criteria or detailed study results. The document notes: "As confirmed in comparative testing, the visual guidance system used by the subject device is accurate, in the sense that it corresponds exactly with the virtual coordinates dictated by the approved placement plan, thus enabling the technician to place the brackets on the working model precisely according to that plan." Again, this is a general statement without specific metrics or details of the comparative testing.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to answer the questions based only on the available information:

A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in measurable terms in the provided document. The general criteria seem to be that the visual guidance system is "accurate" and "corresponds exactly with the virtual coordinates dictated by the approved placement plan."
Reported Device Performance: "the visual guidance system used by the subject device is accurate, in the sense that it corresponds exactly with the virtual coordinates dictated by the approved placement plan, thus enabling the technician to place the brackets on the working model precisely according to that plan."

Acceptance Criteria (inferred)	Reported Device Performance
Visual guidance system for bracket placement is accurate and corresponds exactly with approved virtual placement plan coordinates.	"the visual guidance system used by the subject device is accurate, in the sense that it corresponds exactly with the virtual coordinates dictated by the approved placement plan, thus enabling the technician to place the brackets on the working model precisely according to that plan."

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
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 specified. The ground truth seems to be "the approved placement plan" from the orthodontist.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 is mentioned. The document describes "comparative testing" of the visual guidance system's accuracy, but not a study of human readers’ improvement with AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The "performance data" describes the software generating a digital model and bracket placement, which is then verified against the orthodontist's prescription. This implies a standalone assessment of the software's output matching the desired plan. However, the exact methodology and metrics of this "verification and validation" are not detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the device's accuracy appears to be the "approved placement plan" or "virtual coordinates dictated by the approved placement plan" supplied and approved by the "Dental Professional" or "Orthodontist."
The sample size for the training set
- Not specified. (This device is described as software that calculates ideal positions based on dental impressions/3D models and an orthodontist's plan, rather than a deep learning AI model that would typically have a specific training set size).
How the ground truth for the training set was established
- Not applicable/Not specified. The document does not describe a machine learning model that would require a ground-truthed training set in the conventional sense. The "ground truth" (the approved placement plan) is established by the dental professional for each case being processed by the system.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a wing-like shape above them.

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

March 24, 2016

Great Lakes Orthodontics, Ltd. Mr. Dave Graver Director of Logistics 200 Cooper Ave. Tonawanda, New York 14150

Re: K150702

Trade/Device Name: eXceed Computerized Precision Bracket Placement Solution Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW, NJM, EJF Dated: February 19, 2016 Received: February 23, 2016

Dear Mr. Graver:

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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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 devicerelated adverse events) (21 CFR 803); good 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang -S

for Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K150702
Device Name	eXceed Computerized Precision Bracket Placement Solution
Indications for Use (Describe)	eXceed Computerized Precision Bracket Placement Solution is a software system intended for use as an aid in orthodontic treatment planning to correct Malocclusions in Orthodontic Patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. eXceed Computerized Precision Bracket Placement Solution is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the Dental professional to place multiple brackets at the same time.
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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
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information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for Great Lakes Orthodontics, LTD. The logo features a stylized map of the Great Lakes region of the United States, surrounded by the words "Great Lakes Orthodontics." Below the logo, the company's name is written in a larger font, followed by the tagline "An Employee Owned Company."

Our Vision "Delight our customers. Respect and help our co-workers"

K150702 510K Summary

Submitter's name, address, phone, and contact person:

Great Lakes Orthodontics, Ltd. (Registration# 1316408)

200 Cooper Ave.

Tonawanda, NY 14150

Phone 716-319-1250 (direct)

Fax 716-871-0550

Contact person: Dave Graver

Email: dgraver@greatlakesortho.com

Date summary prepared: March 24, 2016

Trade / Proprietary Name of Device:

Exceed Computerized Precision Bracket Placement Solution

Common name of device:

Accessory to Orthodontic Brackets

Device classification name:

Orthodontic Plastic Bracket (Class II)

Classification regulation: 21CFR 872.5470

Product codes: DYW (Orthodontic plastic bracket), NJM (Orthodontic Ceramic Bracket), and ELF (Orthodontic Metal Bracket)

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200CooperAvenue · P.O. Box5111 · Tonawanda, New York 14151-5111 716-871-1161 • 800-828-7626 • Fax:(716) 871-0550 e-mail info@greatlakesortho.com • Website: www.greatlakesortho.com

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Image /page/4/Picture/0 description: The image shows the logo for Great Lakes Orthodontics, LTD. The logo includes a map of the Great Lakes region of the United States, surrounded by the words "Great Lakes Orthodontics." Below the logo, the words "Great Lakes Orthodontics, LTD." are written in a larger font. Underneath that, it says "An Employee Owned Company".

Our Vision "Delight our customers. Respect and help our co-workers"

Predicate Device:

Ortho CADiQ (510k # K082207)

Intended use/Indications for use

Technological Characteristics

Principals of operation

Using the images provided by the Dental Professional, the software creates a 3D model and identifies the ideal placement of the brackets. The file is sent to the Dental Professional for review and approval. The Dental Professional may adjust the final position of the bracket if desired. A 3D model is printed, and the brackets are placed on the model in the prescribed location, approved by the Orthodontist. An indirect bonding tray is fabricated with the brackets in place. The tray and brackets are sent to the Dental professional. The Dental Professional places the indirect tray using their chosen commercially available bracket adhesive.

While the subject and predicate devices do not have identical Indications for Use statements, they share the same intended use. Both are intended for use as aids in orthodontic treatment planning for use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. Both are intended for use with commercially-available brackets.

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200CooperAvenue · P.O.Box5111 · Tonawanda, New York 14151-5111 716-871-1161 · 800-828-7626 · Fax:{716}671-0550 Email: info@greatlakesortho.com Website: www.greatlakesortho.com

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Image /page/5/Picture/0 description: The image is a logo for Great Lakes Orthodontics. The logo features a map of the United States with the Great Lakes highlighted in white. The words "GREAT LAKES" are written in a circular fashion above the map, and the word "ORTHODONTICS" is written in a circular fashion below the map. The logo is simple and clean, and it effectively communicates the company's name and location.

Great Lakes Orthodontics,LTD.

An Employee Owned Company

Our Vision " Delight our customers. Respect and Help our co-worlters"

The operating principle for Exceed Computerized Precision Bracket Placement Solution and OrthoCAD iQ is identical, with the exception of the guidance method used by the technician in the manufacturing facility when pasting the brackets to the working model, prior to tray fabrication. The difference between the Subject and predicate devices is that the subject device employs a different guidance method for placing the brackets on the working model prior to trays' fabrication. Exceed Computerized Precision Bracket Placement Solution includes visual/physical frames on its models, while OrthoCAD provides virtual visual quidance only.

The difference in operating principle is minor, and does not render the subject device substantially different from the predicate device for the following reasons:

· The intended use of the different guidance method is the same as in the predicate device, providing the technician at the manufacturing facility clear and unequivocal guidance regarding where the brackets are to be placed on the working model, based on the approved placement plan.
As confirmed in comparative testing, the visual guidance system used by the subject ● device is accurate, in the sense that it corresponds exactly with the virtual coordinates dictated by the approved placement plan, thus enabling the technician to place the brackets on the working model precisely according to that plan. As such, it is as safe and effective as the predicate and does not raise any new concerns.

Performance Data

The software is verified and validated by the digital model generated, matching the 3D model and bracket placement locations prescribed and approved by the Orthodontist.

Substantial Equivalence

Great Lakes Orthodontics Ltd has demonstrated that, for the purposes of FDA's regulation of medical devices, the Exceed Computerized Precision Bracket Placement Solution is substantially equivalent to the predicate device in terms of intended use, indications, technical characteristics, and principles of operation.

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200CooperAvenue · P.O.Box5111 · Tonawanda,New York 14151-5111 716-871-1161 · 800-828-7626 · Fax:{716}671-0550 Email: info@greatlakesortho.com Website: www.greatlakesortho.com

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Image /page/6/Picture/0 description: The image is a logo for Great Lakes Orthodontics. The logo features a map of the United States with the Great Lakes highlighted in white. The words "GREAT LAKES" are written in a semi-circle above the map, and the word "ORTHODONTICS" is written in a semi-circle below the map. The logo is simple and clean, and it effectively communicates the company's name and focus.

Great Lakes Orthodontics, LTD.

An Employee Owned Company

Our Vision " Delight our customers. Respect and Help our co-worlters"

TECHNOLOGICAL CHARACTERISTICS

(Similarities & Differences)

	Exceed Computerized Precision BracketPlacement Solution	Ortho CAD iQ
Indications forUse	eXceed Computerized Precision BracketPlacement Solution is a software system intendedfor use as an aid in orthodontic treatment planningto correct Malocclusions in Orthodontic Patients.For use by dental professionals trained inorthodontic treatment, including radiographicanalyses and treatment planning. eXceedComputerized Precision Bracket PlacementSolution is intended for use with commerciallyavailable brackets currently used in standardorthodontic treatment. The end product is anindirect bonding tray for use by the Dentalprofessional to place multiple brackets at the sametime.	Ortho CAD iQ is a computer-guided systemintended for use as an aid in orthodontictreatment planning for use by dentalprofessionals trained in orthodontic treatmentincluding radiographic analyses andtreatment planning. OrthoCAD iQ is intendedfor use with commercially-available bracketsand wires that apply continuous gentle forceto reposition the teeth. It also uses indirectbonding trays to affix the brackets in position.
Key Records	A 3D model is generated from scanned analogimpressions ordirectly from an intra-oral scan	A 3D model is generated fromscanned analog impressions or directly froman intra-oral scan
AdditionalRecords	A panoramic X-ray, facial and intra- oral images	A panoramic X-ray, facial and intra-oralimages
Treatment Plan	A detailed treatment plan is provided by theclinician as part of case submission.	A detailed treatment plan is provided by theclinician as part of case submission.
Virtual BracketPlacementPlan	Using the submitted records and the prescribedtreatment plan, a suggested placement plan isgenerated and sent for review by the clinician. TheClinician utilizes the eXceed software to adjust theplan and later have it approved.	Using the submitted records and theprescribed treatment plan, a suggestedplacement plan is generated and sent forreview by the clinician. The Clinician utilizesthe OrthoCAD software to adjustthe plan and later have it approved.
Manufacturing	A working pre-treatment model, which includestooth and bracket-specific landmarks depicting theposition of the brackets based on the approvedplan, is printed. Brackets are bonded by atechnician within the landmarks.	A working pre-treatment model is printed. Atechnician bonds the brackets to the workingmodel using a pen-like device for steeringthe appliances on the surface of the tooth anda computerized silhouette screened on thetooth depicting the approved bracket position.
FinishedProduct	Vacuum forming then follows to produce patient-specific bracket transfer trays.	Vacuum forming then follows to producepatient-specific bracket transfer trays.

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200CooperAvenue · P.O.Box5111 · Tonawanda,New York 14151-5111 716-871-1161 • 800-828-7626 • Fax:{716) 671-0550 Email: info@greatlakesortho.com _Website= www.greatlakesortho.com

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.