Who is the manufacturer of Overjet Dental Assist?

Overjet, Inc. filed the 510(k) submission for Overjet Dental Assist (K210187).

What is the FDA product code for Overjet Dental Assist?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Overjet Dental Assist?

510(k) clearance (submission type: Traditional).

Does Overjet Dental Assist use AI or machine learning?

Yes. Overjet Dental Assist (K210187) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Overjet Dental Assist?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Overjet Dental Assist get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Overjet Dental Assist

K210187 · Overjet, Inc. · LLZ · May 19, 2021 · Radiology

Device Facts

Record ID	K210187
Device Name	Overjet Dental Assist
Applicant	Overjet, Inc.
Product Code	LLZ · Radiology
Decision Date	May 19, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Overjet Dental Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, dentists and dental hygienists.

Device Story

Cloud-native software; processes bitewing and periapical dental radiographs. Inputs: digital radiographs imported from radiographic devices or practice management systems. Operation: semi-automated image processing; identifies key anatomical points to measure interproximal bone levels. Output: annotated radiographs with bone level measurements. Usage: clinical setting; operated by dentists or dental hygienists. Workflow: clinician reviews automated annotations, modifies as needed, and integrates findings into diagnostic process. Benefit: provides objective measurements to assist in periodontal assessment and treatment planning; does not replace clinical judgment.

Clinical Evidence

Retrospective study of 161 radiographs (65 bitewing, 96 periapical) from 63 subjects. Ground truth established by three dentists and adjudicated by two dental radiologists. Bitewing performance: 98.7% sensitivity, 95.0% specificity, 0.307mm mean absolute difference. Periapical bone level performance: 88.94% sensitivity, 95.96% specificity, 0.353mm mean absolute difference. Periapical root length performance: 90.9% sensitivity, 97.47% specificity, 0.567mm mean absolute difference. Bench testing on 8,777 radiographs showed 82.3-83.0% average precision and 89.5-90.0% average recall.

Technological Characteristics

Cloud-native software as a medical device (SaMD). Web-based interface (Edge, Chrome, Firefox). Compatible with SQL databases. Supports jpg, png, jfif, eop, etp, jif formats. Performs automated linear distance measurements via keypoint detection. Software level of concern: moderate.

Indications for Use

Indicated for dental professionals to aid in measuring mesial and distal bone levels from bitewing and periapical radiographs. Intended for patients 22 years or older with no remaining primary teeth. Not for use on primary dentition.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

EZOrtho (K192888)

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Submission Summary (Full Text)

{0}------------------------------------------------ May 19, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Overjet, Inc. % Mr. Adam Heroux Head of Regulatory Affairs 560 Harrison Ave, Unit 403 BOSTON MA 02118 Re: K210187 Trade/Device Name: Overjet Dental Assist Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 12, 2021 Received: April 21, 2021 Dear Mr. Heroux: 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/cfpmp/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 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 {1}------------------------------------------------ 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 Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K210187 Device Name Overjet Dental Assist Indications for Use (Describe) Overjet Dental Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, dentists and dental hygienists. Intended Patient Population: The intended patient population of the device is patients living in the United States, who are 22 years old or older, and that do not have any remaining primary teeth. Overjet has not evaluated the performance of the device on primary dentition. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | <svg fill="none" height="16px" viewbox="0 0 16 16" width="16px" xmlns="http://www.w3.org/2000/svg"> <path d="M13.25 3.34L5.92 10.67L2.75 7.5L1.92 8.33L5.92 12.33L14.08 4.17L13.25 3.34Z" fill="black"></path> <rect height="15" rx="3.5" stroke="black" width="15" x="0.5" y="0.5"></rect> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | | | <svg fill="none" height="16px" viewbox="0 0 16 16" width="16px" xmlns="http://www.w3.org/2000/svg"> <rect height="15" rx="3.5" stroke="black" width="15" x="0.5" y="0.5"></rect> </svg> 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 of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary (K210187) This summary of 510(k) information is being submitted in accordance with the requirements of 21CFR Part 807.92 - 1. Date 4/12//2021 - 2. Applicant Overjet, Inc. 560 Harrison Ave Unit 403 Boston, MA 02118 Contact Person: Adam Heroux Email: adam@overjet.ai - 3. Trade Name Overjet Dental Assist - 4. Common Name Dental Imaging Software - 5. Classification System, Imaging processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology) - 6. Device Description Overjet Dental Assist developed by Overjet Inc, is a radiological semi automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Overjet Dental Assist is a cloud native Software as a Medical Device that allows users to automate the measurement of interproximal bone levels for bitewing and periapical radiographs, review associated radiographs, view annotations, modify annotations. - 7. Indications for Use Overjet Dental Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. {4}------------------------------------------------ lt should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, dentists and dental hygienists. Intended Patient Population: The intended patient population of the device is patients living in the United States, who are 22 years old or older, and that do not have any remaining primary teeth. Overjet has not evaluated the performance of the device on primary dentition. - 8. Predicate Device Device - EZOrtho Manufacturer - Ewoosoft Co., Ltd. 510k - K192888 - 9. Substantial Equivalence | Device | Ewoosoft EZOrtho v1.0 (predicate) | Overjet Dental Assist (proposed) | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510k | K192888 | K210187 | | Indications | EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists | Overjet Dental Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, dentists and dental hygienists | | Patient Population | Patients receiving dental care | Patients receiving dental care | | Platform | IBM-compatible PC or PC network | Web - Edge, Chrome, Firefox | | OS | Microsoft Window 7, 8, 10 | any | | User Interface | Mouse, Keyboard | Mouse, Keyboard, Trackpad | | Image Input Sources | Images can be scanned, loaded from digital cameras or card readers, or imported from a radiographic imaging device | Images imported from the radiographic device, or from the practice management system | | Image format | DICOM, BMP, JPG, PNG, TIF | jpg, png, jfif, eop, etp, jif | | Patient Database Compatibility | SQL | SQL | | Includes Image Measurement tools | Linear distance, angle | Linear distance | | Image viewing | Full, side by side, thumbnail | Full, Thumbnail | | Image manipulation | Grayscale, invert, emboss, brightness, contrast, gamma, sharpen, median, despeckle, hue, saturation, equalize flip, mirror, masking, rotate, annotation, cephalometric tracing, implant simulations | annotation | | Cephalometric tracing | In addition to the user-configured analysis, standard orthodontic tracing analysis include: Downs Jarabek McNamara Ricketts Jefferson | n/a | | Implant module | Generic | n/a | | 3D imaging capability | None | none | | Image annotation | Text, paint, ellipse, pointer, select, draw, magnify, line, rectangle, ruler, protractor, brush, select region, copy / paste | Line | {5}------------------------------------------------ Overjet Dental Assist is determined to be substantially equivalent to the Ewoosoft EZ Ortho cleared as K192888. Both systems are software intended to support dental professionals in their diagnosis and treatment planning for their dental patients. {6}------------------------------------------------ Both software systems automatically annotate dental radiographs for the dentist. EZ Ortho places calibration points within a radiograph for orthodontic planning, while the Overjet Dental Assist utilizes key points to measure interproximal bone levels. Both systems allow users to visualize the radiograph with the annotations, add their own annotations, and use the information as part of their diagnostic process. Other similarities include both systems have no direct contact with the patient, both systems evaluate oral cavity radiographs, both systems utilize standard image types, and both systems connect to practice management systems. Some differences between the systems include the location of the software, the user interface, and the availability of additional features. A primary difference is the EZ Otho is a local software while Overjet Dental Assist is a cloud native application. While EZ Ortho and Overjet Dental Assist have different user interfaces, both are accessed by computer and are intended for dental professionals to review annotations on dental radiographs. The EZ Ortho software contains additional annotation features that are not required for the Overjet Dental Assist use case. Overjet does not feel that the differences raise a concern of substantial equivalence and these differences do not interfere with the ability of the Overjet software to achieve its intended use. - 10. Performance Testing ## Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. ## Bench Testing Bench testing included evaluation of performance based upon a ground truth data set utilizing Object Keypoint Similarity assessment, Overiet Dental Assist was evaluated with two datasets of 2234 bitewing radiographs, and 6543 periapical radiographs and evaluated the precision and recall against the labeled keypoints within those radiographs. The Overjet met acceptable performance criteria with the following results: | Metric | Bitewing | Periapical | |-------------------|----------|------------| | Average Precision | 82.3% | 83.0% | | Average Recall | 89.5% | 90.0% | {7}------------------------------------------------ #### Clinical Testing Clinical testing of the Overjet Dental Assist software was performed utilizing retrospective clinical subject data from 65 bitewing and 96 periapical radiographs from 63 subjects. The demographics of the data set was as follows: | Subject Age | Count (%) | |----------------------------|-----------| | under 30 | 15 (24%) | | 30-40 | 9 (14%) | | 40-50 | 8 (13%) | | 50-60 | 12 (19%) | | 60-70 | 6 (10%) | | 70 + | 12(19%) | | no information provided | 1 (1%) | | Subject Gender | Count (%) | |----------------|-----------| | F | 46 (73%) | | M | 17 (27%) | No information about ethnicity was available from the dental radiographs. Overjet utilized three US licensed dentists to label interproximal bone levels using the measurement tool in Dexis Webview software for all of the radiographs. These measurements were then adjudicated by two US Dental Radiologists, The final adjudicated measurements were compared against the Overjet Dental Assist predicted measurements. The Overjet Dental Assist software met the prespecified acceptance criteria of >85% sensitivity and specificity when compared to the ground truth, and accuracy of <1.5mm mean absolute difference versus ground truth. The Overjet Dental Assist software demonstrated a modeled 98.7% sensitivity value and 95.0% specificity value, and a mean absolute difference from the ground truth of 0.307mm for measurement of interproximal bone levels in bitewing radiographs. In interproximal bone levels in periapical radiographs, Overjet Dental Assist scored 88.94% sensitivity, 95,96% specificity, and 0,353mm mean absolute difference, Performance of measurement of Periapical Root Length was measured at 90.9% sensitivity, 97.47% specificity, and 0.567mm mean absolute difference. The interproximal bone level value in periapical images while meeting the performance acceptance criteria, did not meet the alpha value of <0.05. The alpha for the hypothesis test was 0.083. Analysis of this data indicated that 33% of the false negatives were {8}------------------------------------------------ related to anatomical overlap that obstructed the CEJ point. In this case human readers were more prone to estimate a bone level point that was obscured. The overall sensitivity of 88% was consistent with the performance of the three ground truth dentists. No adverse effects or complications were recorded associated with this study as all radiographs were retrospective and no treatment decisions were made. All testing demonstrated that the Overjet Dental Assist software met prespecified performance requirements when evaluated against human labeling. #### 11. Conclusion Overjet Dental Assist is substantially equivalent to the predicate device, EZ Ortho. Differences do not raise any concerns about the safety or efficacy of the device.