(114 days)
Not Found
Yes
The description mentions "semi-automated image processing software" and "automate the measurement of interproximal bone levels," which strongly suggests the use of AI/ML for image analysis and feature detection, even though the terms "AI" or "ML" are not explicitly used. The performance metrics (precision, recall, sensitivity, specificity, mean absolute difference) are also typical of evaluations for AI/ML-based image analysis systems.
No
The device is described as an image processing software intended to aid in measurements from radiographs, not to directly treat a condition.
No.
The device aids in measurements but explicitly states it "should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis." This indicates it is not a diagnostic device itself, but rather a tool to assist professionals who perform diagnostics.
Yes
The device is explicitly described as "radiological semi-automated image processing software device" and "cloud native Software as a Medical Device". There is no mention of accompanying hardware components required for its primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: Overjet Dental Assist processes radiological images (bitewing and periapical radiographs). These are images taken of the inside of the body, not samples taken from the body.
- Intended Use: The intended use is to aid dental professionals in measuring bone levels from radiographs. This is an image analysis task, not a diagnostic test performed on a biological sample.
Therefore, while it is a medical device used in a healthcare setting, it does not fit the definition of an In Vitro Diagnostic.
No
The provided text does not contain explicit language stating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / 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.
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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
bitewing and periapical radiographs
Anatomical Site
Teeth (specifically mesial and distal bone levels associated with each tooth)
Indicated Patient Age Range
22 years old or older, and that do not have any remaining primary teeth.
Intended User / Care Setting
Trained professionals including, but not limited to, dentists and dental hygienists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench testing:
Sample Size: 2234 bitewing radiographs, and 6543 periapical radiographs
Data Source: Not explicitly stated, but "ground truth data set"
Annotation Protocol: evaluated the precision and recall against the labeled keypoints within those radiographs.
Clinical Testing:
Sample Size: 65 bitewing and 96 periapical radiographs from 63 subjects.
Data Source: retrospective clinical subject data
Annotation Protocol: 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing:
Study Type: Software verification and validation testing
Sample Size: Not specified for this section.
Key Results: 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:
Study Type: Bench testing (evaluation of performance based upon a ground truth data set utilizing Object Keypoint Similarity assessment)
Sample Size: 2234 bitewing radiographs, and 6543 periapical radiographs
Key Results: 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%
Clinical Testing:
Study Type: Clinical testing
Sample Size: 65 bitewing and 96 periapical radiographs from 63 subjects.
Key Results:
The Overjet Dental Assist software met the prespecified acceptance criteria of >85% sensitivity and specificity when compared to the ground truth, and accuracy of
§ 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).
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
(K210187)
This summary of 510(k) information is being submitted in accordance with the requirements of 21CFR Part 807.92
-
- Date 4/12//2021
-
- Applicant
Overjet, Inc. 560 Harrison Ave Unit 403 Boston, MA 02118 Contact Person: Adam Heroux Email: adam@overjet.ai
-
- Trade Name Overjet Dental Assist
-
- Common Name Dental Imaging Software
-
- Classification System, Imaging processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology)
-
- 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.
-
- 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.
- Indications for Use
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.
-
- Predicate Device
Device - EZOrtho Manufacturer - Ewoosoft Co., Ltd. 510k - K192888
- Predicate Device
-
- 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.
-
- 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