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 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria	Reported Performance (Bitewing Radiographs)	Reported Performance (Periapical Radiographs)
Sensitivity	>85%	98.7%	88.94%
Specificity	>85%	95.0%	95.96%
Mean Absolute Difference (Bone Level Measurement)	<1.5mm	0.307mm	0.353mm
Mean Absolute Difference (Periapical Root Length Measurement)	<1.5mm (implied, as it's a measurement)	Not applicable	0.567mm

Note regarding "Periapical Root Length": While the acceptance criteria for sensitivity, specificity, and mean absolute difference are explicitly stated for bone level measurements, the document also reports performance for "Periapical Root Length" with similar metrics and a mean absolute difference. It's reasonable to infer a similar acceptance criterion for MAE for this measurement type.

2. Sample Sizes and Data Provenance

Test Set (Clinical Testing):
- Sample Size: 65 bitewing and 96 periapical radiographs from 63 subjects.
- Data Provenance: Retrospective clinical subject data from patients in the United States, 22 years old or older, without primary teeth. No information about ethnicity was available.
Test Set (Bench Testing):
- Sample Size: 2234 bitewing radiographs and 6543 periapical radiographs.
- Data Provenance: Not explicitly stated, beyond being "ground truth data set utilizing Object Keypoint Similarity assessment." The context suggests this is also retrospective imaging data.
Training Set (not explicitly called out as such here, but implied as distinct from the validation sets):
- Sample Size: Not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated.

3. Number of Experts to Establish Ground Truth for Test Set & Qualifications

Number of Experts: 3 US licensed dentists for initial labeling, plus 2 US Dental Radiologists for adjudication.
Qualifications of Experts: US licensed dentists; US Dental Radiologists. No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

Clinical Testing: The adjudication method was "initial measurements by three US licensed dentists, which were then adjudicated by two US Dental Radiologists." This can be interpreted as a form of expert consensus and review. It's not a standard 2+1 or 3+1, but a multi-expert review process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No explicit MRMC comparative effectiveness study was done to quantify the improvement of human readers with AI assistance versus without. The study focuses on standalone performance against expert-derived ground truth. The document does state, "The overall sensitivity of 88% was consistent with the performance of the three ground truth dentists," which indirectly compares the device's sensitivity to human performance on a specific metric, but this is not a formal MRMC study of human reading with and without AI.

6. Standalone Performance Study

Yes, a standalone study was done. The entire "Clinical Testing" section describes the device's performance (sensitivity, specificity, mean absolute difference) when compared against an expert-established ground truth. The device results are reported directly without human intervention in the reported metrics.

7. Type of Ground Truth Used

Expert Consensus. For the clinical testing, the ground truth was established by three US licensed dentists using a measurement tool, whose measurements were then adjudicated by two US Dental Radiologists. For the bench testing, it mentions "labeled keypoints," implying expert labeling.

8. Sample Size for the Training Set

Not explicitly stated in the provided text. The document refers to "the Overjet met acceptable performance criteria with the following results:" and then lists results for "Bench Testing" and "Clinical Testing," which are typically considered validation/test sets, not the training set itself.

9. How Ground Truth for Training Set Was Established

Not explicitly stated in the provided text, as the size and provenance of the training set itself are not detailed. It can be inferred that similar expert labeling processes would have been used to establish ground truth for training data, but this is not confirmed.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K210187

Device Name

Overjet Dental Assist

Indications for Use (Describe)

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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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
1. Applicant

Overjet, Inc. 560 Harrison Ave Unit 403 Boston, MA 02118 Contact Person: Adam Heroux Email: adam@overjet.ai

1. Trade Name Overjet Dental Assist
1. Common Name Dental Imaging Software
1. Classification System, Imaging processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology)
1. Device Description

1. 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.

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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:

1. Predicate Device
  Device - EZOrtho Manufacturer - Ewoosoft Co., Ltd. 510k - K192888
1. Substantial Equivalence

Device	EwoosoftEZOrtho v1.0(predicate)	Overjet Dental Assist(proposed)
510k	K192888	K210187
Indications	EzOrtho is a softwareindicated for use by dentistswho provide orthodontictreatment for image analysis,simulation, profilogram,VTO/STO and patientconsultation. Resultsproduced by the software'sdiagnostic, treatment planningand simulation tools aredependent on theinterpretation of trained andlicensed practitioners ordentists	Overjet Dental Assist is aradiological semi-automatedimage processing software deviceintended to aid dentalprofessionals in themeasurements of mesial anddistal bone levels associated witheach tooth. It should not be usedin-lieu of full patient evaluation orsolely relied upon to make orconfirm a diagnosis. The systemis to be used by trainedprofessionals including, but notlimited to, dentists and dentalhygienists
PatientPopulation	Patients receiving dental care	Patients receiving dental care
Platform	IBM-compatible PC or PCnetwork	Web - Edge, Chrome, Firefox
OS	Microsoft Window 7, 8, 10	any
User Interface	Mouse, Keyboard	Mouse, Keyboard, Trackpad
Image InputSources	Images can be scanned,loaded from digital camerasor card readers, or importedfrom a radiographic imagingdevice	Images imported from theradiographic device, or from thepractice management system
Image format	DICOM, BMP, JPG, PNG, TIF	jpg, png, jfif, eop, etp, jif
Patient DatabaseCompatibility	SQL	SQL
Includes ImageMeasurementtools	Linear distance, angle	Linear distance
Image viewing	Full, side by side, thumbnail	Full, Thumbnail
Imagemanipulation	Grayscale, invert, emboss,brightness, contrast, gamma,sharpen, median, despeckle,hue, saturation, equalize flip,mirror, masking, rotate,annotation, cephalometrictracing, implant simulations	annotation
Cephalometrictracing	In addition to theuser-configured analysis,standard orthodontic tracinganalysis include: DownsJarabek McNamara RickettsJefferson	n/a
Implant module	Generic	n/a
3D imagingcapability	None	none
Image annotation	Text, paint, ellipse, pointer,select, draw, magnify, line,rectangle, ruler, protractor,brush, select region, copy /paste	Line

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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.

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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.

1. 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%

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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 informationprovided	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

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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.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).