Who is the manufacturer of Videa Perio Assist?

Videahealth, Inc. filed the 510(k) submission for Videa Perio Assist (K223296).

What is the FDA product code for Videa Perio Assist?

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

What is the regulatory pathway for Videa Perio Assist?

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

Does Videa Perio Assist use AI or machine learning?

Yes. Videa Perio Assist (K223296) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Videa Perio Assist?

Overjet Dental Assist (K210187).

Who can help prepare an FDA 510(k) submission like Videa Perio 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 Videa Perio 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.

Videa Perio Assist

K223296 · Videahealth, Inc. · QIH · Feb 6, 2023 · Radiology

Device Facts

Record ID	K223296
Device Name	Videa Perio Assist
Applicant	Videahealth, Inc.
Product Code	QIH · Radiology
Decision Date	Feb 6, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device, Pediatric

Intended Use

Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Measurements are made available as linear distances or relative percentages. 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

Videa Perio Assist is a cloud-based, AI-powered software accessed via API through a dental image viewer. It processes bitewing and periapical radiographs to automatically measure interproximal alveolar bone levels. The device identifies landmarks to calculate linear distances (mm) and percentages of root length, outputting these as visual lines and numerical data on the radiograph. Used by dentists and dental hygienists in clinical settings to assist in periodontal assessment. It does not replace clinical diagnosis; it provides objective measurements to aid decision-making. If no teeth are detected, the system notifies the user. The device is intended for patients with permanent dentition.

Clinical Evidence

Clinical study evaluated 189 radiographs (2,350 lines) labeled by US licensed dentists and adjudicated by periodontists. Performance on bitewing radiographs: 92.8% sensitivity, 89.4% specificity, and mean absolute error below 1.5mm. Performance on periapical radiographs: 88.3% sensitivity, 87.0% specificity, and mean absolute error below 1.5mm. Bench testing on 996 radiographs (16,131 landmarks) confirmed performance requirements. Generalizability analysis across sensor manufacturers and age groups showed no outliers impacting safety or effectiveness.

Technological Characteristics

Cloud-based software-only device; API-based deployment. Uses AI algorithms for automated landmark detection and linear measurement on dental radiographs (bitewing/periapical). Supports DICOM, rvg, png, tiff, jpg, jpeg, and dex formats. No patient-contacting components; no electrical/EMC requirements. Software level of concern: moderate.

Indications for Use

Indicated for patients ≥12 years of age with permanent dentition present in the radiograph, undergoing routine dental visits or suspected of having interproximal bone level concerns.

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

Overjet Dental Assist (K210187)

Related Devices

K232440 — Adravision Perio · Adra Corporation · Dec 5, 2023
K210187 — Overjet Dental Assist · Overjet, Inc. · May 19, 2021
K230144 — Denti.AI Detect · Denti.Ai Technology, Inc. · Oct 6, 2023
K251002 — Videa Dental AI · Videahealth, Inc. · Sep 19, 2025
K243230 — Second Opinion® BLE · Pearl, Inc. · May 9, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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. February 6, 2023 VideaHealth, Inc. % Adam Foresman Director of Quality & Regulatory Affairs 179 South Street. Floor 5 BOSTON MA 02111 Re: K223296 Trade/Device Name: Videa Perio Assist Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: January 5, 2023 Received: January 6, 2023 Dear Adam Foresman: 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/cfpmn/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 {1}------------------------------------------------ 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 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 mediation-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, Lu Jiang 2023.02.06 09:34:26 -05'00' Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K223296 Device Name Videa Perio Assist ### Indications for Use (Describe) Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Measurements are made available as linear distances or relative percentages. 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. 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 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}------------------------------------------------ In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for the Videa Perio Assist device is provided below. #### 1. SUBMITTER | Applicant: | VideaHealth, Inc. 179 South Street, Floor 5 Boston, MA, 02111 +1 617-340-9940 florian@videa.ai | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------| | Contact & Submission Correspondent: | Adam Foresman Director of Quality & Regulatory Affairs VideaHealth, Inc. +1 617-340-9940 adam@videa.ai | | Date Prepared: | October 14, 2022 | #### DEVICE 2. | Device Trade Name: | Videa Perio Assist | |-------------------------------------|------------------------------------------------| | Device Common Name: | Interproximal bone level measurement | | Classification Name | Medical image management and processing system | | Classification Regulation Number | 21 CFR 892.2050 | | Device Class: | 2 | | Product Code: | QIH | #### PREDICATE DEVICE 3. | Predicate Device: | K210187 Overjet Dental Assist (Overjet, Inc.) | |-------------------|-----------------------------------------------| |-------------------|-----------------------------------------------| {4}------------------------------------------------ #### DEVICE DESCRIPTION 4. Videa Perio Assist (VPA) software is a cloud-based AI-powered medical device for the automatic measurement of tooth interproximal alveolar bone level in dental radiographs. The device itself is available as an API (Application Programming Interface) behind a firewalled network. The device returns 1) a series of points with connecting lines measuring the mesial and distal alveolar bone levels associated with each tooth 2) this distance expressed in millimeters and/or as a percentage of the root length. Videa Perio Assist is accessed by the trained professional through their image viewer. From within the image viewer the user can upload a radiograph to Videa Perio Assist and then review the results. The device outputs a line to identify these points which calculate the interproximal bone level. The device output will show all applicable measurements from one radiograph regardless of the number of teeth present. If no teeth are present the device outputs a clear indication that there are no identifiable teeth to calculate the interproximal bone level. The intended users of Videa Perio Assist are trained professionals such as dentists and dental hygienists. The intended patients of Videa Perio Assist are patients 12 years and above with permanent dentition undergoing routine dental visits or suspected of having interproximal bone level concerns. Videa Perio Assist may only be used with patients with permanent dentition present in the radiograph. #### INTENDED USE/INDICATIONS FOR USE ડ. Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Measurements are made available as linear distances or relative percentages. 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. #### SUBSTANTIAL EQUIVALENCE 6. # Comparison of Indications Overjet Dental Assist and Videa Perio Assist both analyze dental radiographs and measure interproximal bone level. Both devices are only intended as an aid to the trained professional and are not intended to replace the diagnosis by the physician. Both devices are intended to assist dental professionals by identifying and measuring interproximal bone levels on dental radiographs. Videa Perio Assist's Indication For Use includes additional description on the output of the device which is not a safety or efficacy concern. {5}------------------------------------------------ The difference in patient ages does not constitute a safety or efficacy concern as both devices limit use to permanent dentition patients, Videa Perio Assist artificial intelligence algorithm was trained with that patient population and the Videa Perio Assist testing has shown to be safe and effective for patients between the ages of 12 and 22 years of age with permanent dentition present in the radiograph. Likewise the image format differences are not a safety or efficacy concern as Videa Perio Assist has performed all required training and testing with the image formats listed in Table 1. ### Technological Comparisons Table 1 compares the key technological feature of the subject devices to the predicate device (Overjet Inc., K210187). | | Proposed Device | Predicate Device | |---------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | 510(k) Number | TBD | K210187 | | Applicant | VideaHealth, Inc. | Overjet, Inc. | | Device Name | Videa Perio Assist | Overjet Dental Assist | | Classification Regulation | 892.2050 | 892.2050 | | Product Code | QIH | LLZ | | Image Modality | X-Ray | X-Ray | | Study Type | Bitewing and periapical Images | Bitewing and periapical Images | | Patient Population | Patients ≥12 years of age with permanent dentition present in the radiograph | Adults ≥ 22 years of age | | OS | Any | Any | | Intended User | Dentists and dental hygienists | Dentists and dental hygienists | | Image Input Source | Images imported from the radiographic device, or from the practice management system | Images imported from the radiographic device, or from the practice management system | Table 1: Device Comparison Table {6}------------------------------------------------ | | Proposed Device | Predicate Device | |-------------------------------------|---------------------------------------|-------------------------------| | Image Format | DICOM, rvg, png, tiff, jpg, jpeg, dex | jpg, png, jfif, eop, etp, jif | | Includes Image Measurement tools | Linear distance | Linear distance | #### 7. PERFORMANCE DATA ### Biocompatibility, Sterilization, and Reprocessing Not applicable. The subject device is a software-only device. There are no direct or indirect patient-contacting components of the subject device. There are no sterile or reprocessed components. # Electrical Safety and Electromagnetic Compatibility (EMC) Not applicable. The subject device is a software-only device. It contains no electric components, generates no electrical emissions, and uses no electrical energy of any type. ## 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. # Bench Testing Non-clinical bench testing was performed on 996 radiographs and 16,131 landmarks. Bitewing and periapical radiographs were ground truth labeled across two phases. The Videa Perio Assist measurement results where scored versus ground-truthed landmarks. Bench testing demonstrated that the Videa Perio Assist meets performance requirements. The acceptance criteria was as follows: - A recall greater than 82% ● - A precision greater than 82% ● VPA met pre-specified acceptance criteria on bitewing radiographs with a recall of 94.4% and precision of 84.3%. VPA met pre-specified acceptance criteria on periapical radiographs with a recall of 91.9%. In the CEJ-ABL subgroup study, participants were more likely to estimate an obscured interproximal bone level point on overlapping teeth and the precision was 79.1%. Bench testing has sensor manufacturer and patient age subgroup analysis for generalizability in a similar method as described in the clinical study generalizability section below. The sensor manufacturer and patient age did not have any outliers in the bench study. {7}------------------------------------------------ ## Animal Testing Not applicable. Animal studies are not necessary to establish the substantial equivalence. ## Clinical Testing Clinical testing was performed on 189 radiographs and analyzed over 2.350 lines. US licensed dentists labeled data across two phases, and two US licensed periodontists adjudicated those labels to establish a reference standard for the study. These final results were analyzed against the Videa Perio Assist predictions. | Subject Age | Percentage | |-------------|------------| | 12 - 21 | 31% | | 22 - 40 | 35% | | 41 - 60 | 21% | | 61 - 75 | 9% | | 75 + | 4% | Table 2: Demographic breakdown by age ### Table 3: Demographic breakdown by gender | Subject Gender | Percentage | |----------------|------------| | Male | 47% | | Female | 53% | ### Table 4: Intraoral sensor breakdown by manufacturer | Sensor Manufacturer | Percentage | |------------------------|------------| | Dentsply Sirona | 13% | | KaVo Kerr | 48% | | Carestream Dental | 39% | There were seven intraoral sensor models across these three manufacturers. Ethnicity data was not available for the radiographs. The acceptance criteria was as follows: - A sensitivity greater than 82% ● - A specificity greater than 81% . - A mean absolute error less than 1.5mm ● {8}------------------------------------------------ VPA met pre-specified acceptance criteria on bitewing radiographs with a sensitivity of 92.8%, specificity of 89.4% and mean absolute error below the thresholds. VPA met pre-specified acceptance criteria on periapical radiographs with a sensitivity of 88.3%, specificity of 87.0% and mean absolute error below the thresholds. All subgroups except for perianical CEJ-ABL, where study participants were more likely to estimate an obscured interproximal bone level point on overlapping teeth, met the pre-specified acceptance criteria. | Radiographic View Type | Line Type | Sensitivity (%) | Specificity (%) | Mean Absolute Error (mm) | |---------------------------|-----------|----------------------------|-------------------------------------|-----------------------------| | Bitewing | CEJ->ABL | Met acceptance criteria | Met acceptance criteria | Met acceptance criteria | | Periapical | All | Met acceptance criteria | Met acceptance criteria | Met acceptance criteria | | | CEJ->ABL | Met acceptance criteria | Did not meet acceptance criteria | Met acceptance criteria | | | CEJ->RT | Met acceptance criteria | Met acceptance criteria | Met acceptance criteria | | | ABL->RT | Met acceptance criteria | Met acceptance criteria | Met acceptance criteria | Table 5: Clinical Performance Metrics of VPA by radiographic view type and line type. No adverse events were observed during the clinical study. Clinical testing demonstrated that the Videa Perio Assist meets performance requirements. ### Generalizability The intraoral sensor manufacturer and patient age influence on bench testing and clinical testing results was assessed for Videa Perio Assist's generalizability. The results for the clinical testing analysis are in Table 7. For both tables, the generalizability acceptance criteria was met if the metric's mean met the respective target acceptance criteria threshold (for example if 'patient's 12 to 21 years of age' subgroup's analysis was greater than or containing 82% for sensitivity). {9}------------------------------------------------ | Radiographic View Type | Dentsply Sirona | KaVo Kerr | Carestream Dental | |----------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|----------------------------------------------| | Bitewing Measurements | Met acceptance criteria for sensitivity and mean absolute error. Specificity did not meet acceptance criteria. | Met acceptance criteria for all 3 metrics | Met acceptance criteria for all 3 metrics | | Periapical Measurements | Met acceptance criteria for all 3 metrics | Met acceptance criteria for all 3 metrics | Met acceptance criteria for all 3 metrics | | Table 6: Clinical Performance Metrics of VPA by intraoral sensor manufacturer across all models. | | | |--------------------------------------------------------------------------------------------------|--|--| | | | | In both the bench and clinical studies, statistical analysis by sensors demonstrated a high level of generalizability. No sensor manufacturers or models were clear outliers. From Table 6, the VPA device missed the acceptance criteria for specificity in the Sirona sensors on bitewing radiographs vs. the acceptance criteria. This is not a safety or effectiveness concern as this does not impact the millimeter accuracy when a prediction is made. Table 7: Clinical Performance Metrics of VPA by patient age. | Radiographic View Type | Patients 12 to 21 Years of Age | Patients 22 to 40 Years of Age | Patients 41 to 60 Years of Age | Patients 61 Years of Age and Older | |----------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Bitewing Measurements | Met acceptance criteria for all 3 metrics | Met acceptance criteria for all 3 metrics | Met acceptance criteria for all 3 metrics | Met acceptance criteria for sensitivity and mean absolute error. Specificity did not meet acceptance criteria. | | Periapical Measurements | Met acceptance criteria for all 3 metrics | Met acceptance criteria for all 3 metrics | Met acceptance criteria for all 3 metrics | Met acceptance criteria for all 3 metrics | In both the bench and clinical studies, statistical analysis by patient age demonstrated a high level of generalizability. No patient age group was a clear outlier. From Table 7, the VPA device missed the acceptance criteria for specificity in the 'Patients 61 Years and older' on bitewing radiographs vs. the acceptance criteria. This is not a safety or effectiveness concern as this does not impact the millimeter accuracy when a prediction is made. {10}------------------------------------------------ ### Conclusion There are technological differences, as discussed above these differences in technological characteristics do not raise different questions of safety and efficacy. Although the exact definition of a pass or fail for sensitivity and specificity calculations may differ between OverJet Dental Assist and VideaHealth, the results of the bench testing and clinical testing demonstrate that the performance of Videa Perio Assist is comparable to that of Overjet Dental Assist. Both Overjet Dental Assist and Videa Perio Assist met their acceptance criteria and both did not pass a specific subgroup on periapical images where tooth overlap was common. Therefore, Videa Perio Assist can be found substantially equivalent to Overjet Dental Assist.