(129 days)
Not Found
Yes
The device description explicitly states it is an "AI-powered medical device" and mentions "Artificial intelligence algorithms" and "Supervised Deep Learning". The document also references relevant AI/ML guidance documents.
No
The device is a computer-assisted detection (CADe) device that analyzes radiographs to identify and localize features. It does not directly provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older. Suspected Dental Findings: Caries, Attrition, Broken/Chipped Tooth, Restorative Imperfections, Pulp Stones, Dens Invaginatus, Periapical Radiolucency, Widened Periodontal Ligament, Furcation, Calculus." This indicates that the device is used to identify and localize features related to suspected dental findings, which falls under the definition of a diagnostic device. The performance studies also refer to "diagnostic accuracy."
Yes
The device description explicitly states that "Videa Dental Assist (VDA) software is a cloud-based AI-powered medical device" and is "available as a service via an API". It processes existing radiographic images and provides analysis results, without including or requiring any specific hardware components beyond the user's existing dental image viewer and network access.
Based on the provided information, Videa Dental Assist is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Videa Dental Assist's Function: Videa Dental Assist analyzes intraoral radiographs (X-rays), which are images of the inside of the mouth. It does not analyze biological specimens taken from the body.
- Intended Use: The intended use is to assist dental professionals in identifying and localizing features on dental radiographs. This is an imaging analysis tool, not a test performed on a biological sample.
Therefore, Videa Dental Assist falls under the category of a medical device that processes medical images, but it is not an IVD.
No
The document does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The term "PCCP" is mentioned in the "Control Plan Authorized (PCCP) and relevant text" section with "Not Found", indicating no relevant text about its authorization.
Intended Use / Indications for Use
Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize the following features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older.
Suspected Dental Findings:
- Caries
- Attrition
- Broken/Chipped Tooth
- Restorative Imperfections
- Pulp Stones
- Dens Invaginatus
- Periapical Radiolucency
- Widened Periodontal Ligament
- Furcation
- Calculus
Historical Treatments:
- Crown
- Filling
- Bridge
- Post and Core
- Root Canal
- Endosteal Implant
- Implant Abutment
- Bonded Orthodontic Retainer
- Braces
Normal Anatomy:
- Maxillary Sinus
- Maxillary Tuberosity
- Mental Foramen
- Mandibular Canal
- Inferior Border of the Mandible
- Mandibular Tori
- Mandibular Condyle
- Developing Tooth
- Erupting Teeth
- Non-matured Erupted Teeth
- Exfoliating Teeth
- Impacted Teeth
- Crowding Teeth
Product codes (comma separated list FDA assigned to the subject device)
MYN
Device Description
Videa Dental Assist (VDA) software is a cloud-based AI-powered medical device for the automatic detection of the features listed in the Indications For Use statement in dental radiographs. The device itself is available as a service via an API (Application Programming Interface) behind a firewalled network. Provided proper authentication and an eligible bitewing, periapical or panoramic image, the device returns a set of bounding boxes representing the suspect dental finding, historical treatment or normal anatomy detected.
VDA is accessed by the dental practitioner through their dental image viewer. From within the dental viewer the user can upload a radiograph to VDA and then review the results. The device outputs a binary indication to identify the presence of findings for each indication. If findings are present the device outputs the number of findings by finding type and the coordinates of the bounding boxes for each finding. If no findings are present the device outputs a clear indication that there are no findings identified for each indication. The device output will show all findings from one radiograph regardless of the number of teeth present.
The intended users of Videa Dental Assist are trained dental professionals such as dentists and dental hygienists. For the suspect dental findings indications specifically, VDA is intended to be used as an adjunct tool and should not replace a dentist's review of the image. Only dentists that are performing diagnostic activities shall use the suspect dental finding indications.
VDA 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 dental professionals including, but not limited to, dentists and dental hygienists.
Depending on the specific VDA indication for use, the intended patients of Videa Dental Assist are patients 3 years of age and older above with primary, mixed and/or permanent dentition undergoing routine dental visits or suspected of one of the suspected dental findings listed in the VDA indications for use statement above. VDA may be used on eligible bitewing, periapical or panoramic radiographs depending on the indication.
See Table 1 below for the specific patient age group and image modality that each VDA indication for use is designed and tested to meet. VDA uses the images metadata to only show the indications for the patient age and image modalities in scope as shown in Table 1. VDA will not show any findings output for an indication for use that is outside of the patient age and radiographic view scope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Videa Dental Assist (VDA) software is a cloud-based AI-powered medical device for the automatic detection of the features listed in the Indications For Use statement in dental radiographs.
AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
Good Machine Learning Practice for Medical Device Development: Guiding Principles . October 2021.
Videa Dental Assist artificial intelligence algorithms were trained with that patient population and VideaHealth followed the pediatric medical device guidance document among other standards and guidance documents listed in Section 7 below in the design process.
Videa Dental Assist artificial intelligence algorithms were trained with bitewing, periapical and panoramic radiographs.
There are no significant differences between Videa Dental Assist and Videa Caries Assist in the AI model training methodology or other technological differences that raise different questions of safety and efficacy.
Input Imaging Modality
intraoral radiographs
bitewing, periapical, and panoramic radiographs
X-Ray
Bitewing Images, Periapical Images, and Panoramic Images.
Anatomical Site
Dental
Indicated Patient Age Range
3 years or older.
3 years of age and older with primary, mixed and/or permanent dentition.
Caries: 3 years and older
Attrition: 3 years and older
Broken/Chipped: 3 years and older
Restorative Imperfection: 3 years and older
Pulp Stone: 12 years of age and older with permanent dentition
Dens Invaginatus: 3 years & older
Periapical Radiolucency: 22 years of age and older with permanent dentition
Furcation: 22 years of age and older with permanent dentition
Calculus: 3 years and older
Widened Periodontal Ligament: 3 years and older
Historical Treatments: All Indications: 3 years and older
Normal Anatomy: All Indications: 12 years and older (for Impacted Tooth, Mental Foramen, Maxillary Tuberosity), 3 years and older (for all other indications except Mandibular Condyle)
Intended User / Care Setting
trained dental professionals such as dentists and dental hygienists.
Dental professionals
US licensed dentists
Description of the training set, sample size, data source, and annotation protocol
Not Found. The document only mentions that the AI algorithms were trained with specific patient populations and radiographic views.
Description of the test set, sample size, data source, and annotation protocol
Bench Testing:
The dataset was 1,445 radiographs collected from more than 35 US sites that were ground-truthed by three US board-certified dentists. The patients in the dataset were 18% female and 17% male, 16% other and 48% unknown. There were N=17 sensor manufacturers in the study and 8 sensor manufacturers had enough samples to perform generalizability statistical analysis on. Those image sensors were: AirTechniques, Carestream, Dexis, Gendex, Kavo, Schick, PaloDex Group, and Sirona.
Age distribution: 3 - 11 years (13%), 12 - 21 years (15%), 22 - 40 years (19%), 41 - 60 years (19%), 61 and older (16%), Unknown (18%).
Image breakdown by radiographic view: Bitewing (45%), Periapical (43%), Panoramic (12%).
Clinical Testing:
378 radiographs collected from over 25 US locations spread across the country. US licensed dentists labeled the data and a US licensed dentist adjudicated those labels to establish a reference standard for the study.
There were N=26 readers that participated in the study and reviewed all images with and without VDA AI predictions in a randomized fashion.
Patient gender distribution: 24% female, 21% male, 15% other, and 39% unknown.
Sensor manufacturers: N=6 sensor manufacturers had enough samples for generalizability statistical analysis: AirTechniques, Carestream, Dexis, Gendex, Kavo, and Schick.
Age distribution: 3 - 11 years (28%), 12 - 21 years (20%), 22 - 40 years (14%), 41 - 60 years (14%), 61 and older (8%), Unknown (15%).
Radiographic view breakdown: Bitewing (56%), Periapical (44%), Panoramic (N/A. Not in scope).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
Study Type: Standalone Performance Assessment.
Sample Size: 1,445 radiographs.
Standalone Performance: Assessed sensitivity and specificity for all suspect dental finding, historical treatment and normal anatomy VDA indications. All met acceptance criteria except caries specificity, which still performed well enough to pass the clinical study. Also assessed false positive fraction rate, non-lesion fraction, and positive predictive value.
Key Results:
- All VDA historical treatment and normal anatomy indications met their sensitivity and specificity acceptance criteria.
- All VDA suspect dental findings indications met their sensitivity and specificity acceptance criteria with the exception of caries specificity.
Clinical Testing:
Study Type: Fully crossed, randomized, multiple reader multiple case (MRMC) controlled study.
Sample Size: 378 radiographs.
MRMC: Determined whether the diagnostic accuracy of readers aided by VDA is superior to reader accuracy when unaided by VDA, as determined by the AFROC Figure of Merit (AFROC FOM).
Hypothesis: Ho: AFROC FOMaided - AFROC FOMumaided ≤ 0, H: AFROC FOMaided - AFROC FOMumaided > 0.
Key Results: All Videa Dental Assist indications in the clinical study met their acceptance criteria for AFROC FOM.
Average Percentage Improvement With VDA (VDA Aided vs. Unaided Mean AFROC FOM):
- Attrition: 0.171 (28.5% improvement; p-value 3.3e-16)
- Broken or Chipped: 0.105 (15.3% improvement; p-value 1.5e-11)
- Calculus: 0.163 (23.0% improvement; p-value e-12)
- Caries: 0.024 (4.3% improvement; p-value 0.0085)
- Dens Invaginatus: 0.236 (36.8% improvement; p-value 1.9e-9)
- Furcation: 0.199 (29.7% improvement; p-value 0.00057)
- Periapical Radiolucency: 0.092 (11.5% improvement; p-value 0.0072)
- Pulp Stone: 0.211 (35.4% improvement; p-value 2.2e-16)
- Restorative Imperfection: 0.164 (27.9% improvement p-value of
§ 892.2070 Medical image analyzer.
(a)
Identification. Medical image analyzers, including computer-assisted/aided detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, is a prescription device that is intended to identify, mark, highlight, or in any other manner direct the clinicians' attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians. This device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. This device is not intended to replace the review by a qualified radiologist, and is not intended to be used for triage, or to recommend diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the image analysis algorithms including a description of the algorithm inputs and outputs, each major component or block, and algorithm limitations.
(ii) A detailed description of pre-specified performance testing methods and dataset(s) used to assess whether the device will improve reader performance as intended and to characterize the standalone device performance. Performance testing includes one or more standalone tests, side-by-side comparisons, or a reader study, as applicable.
(iii) Results from performance testing that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures (
e.g., receiver operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain a sufficient number of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.(iv) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results; and cybersecurity).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use.
(ii) A detailed description of the intended reading protocol.
(iii) A detailed description of the intended user and user training that addresses appropriate reading protocols for the device.
(iv) A detailed description of the device inputs and outputs.
(v) A detailed description of compatible imaging hardware and imaging protocols.
(vi) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality or for certain subpopulations), as applicable.(vii) Device operating instructions.
(viii) A detailed summary of the performance testing, including: test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
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December 15, 2023
Image /page/0/Picture/1 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.
VideaHealth, Inc. % Adam Foresman Director of Quality & Regulatory Affairs 179 South Street Floor 5 BOSTON. MA 02111
Re: K232384
Trade/Device Name: Videa Dental Assist Regulation Number: 21 CFR 892.2070 Regulation Name: Medical Image Analyzer Regulatory Class: Class II Product Code: MYN Dated: July 31, 2023 Received: August 8, 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232384
Device Name Videa Dental Assist
Indications for Use (Describe)
Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize the following features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older. Suspected Dental Findings:
· Caries
- · Attrition
- · Broken/Chipped Tooth
- · Restorative Imperfections
- · Pulp Stones
- · Dens Invaginatus
- Periapical Radiolucency
- · Widened Periodontal Ligament
- · Furcation
- Calculus
Historical Treatments:
- Crown
- · Filling
- · Bridge
- Post and Core
- · Root Canal
- Endosteal Implant
- Implant Abutment
- · Bonded Orthodontic Retainer
- · Braces
Normal Anatomy:
- · Maxillary Sinus
- · Maxillary Tuberosity
- · Mental Foramen
- · Mandibular Canal
- · Inferior Border of the Mandible
- Mandibular Tori
- · Mandibular Condyle
- · Developing Teeth
- · Erupting Teeth
- · Non-matured Erupted Teeth
- · Exfoliating Teeth
- · Impacted Teeth
- · Crowding Teeth
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
3
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4
510(k) Summary
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for the Videa Dental Assist device is provided below.
| 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: | July 31, 2023 |
1. SUBMITTER
2. DEVICE
| Device Trade Name: | Videa Dental Assist |
|---|---|
| Device Common Name: | Dental AI System |
| Classification Name: | Medical Image Analyzer |
| Classification Regulation | |
| Number: | 21 CFR 892.2070 |
| Device Class: | 2 |
| Product Code: | MYN |
PREDICATE DEVICE
| Device Trade Name: | Videa Caries Assist |
|---|---|
| Device Common Name: | Dental AI System |
| Classification Name: | Medical Image Analyzer |
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| Classification Regulation
| Number: | 21 CFR 892.2070 |
|---|---|
| Device Class: | 2 |
| Product Code: | MYN |
PREDICATE DEVICE 3.
| Predicate Device: | K213795 VideaHealth's Videa Caries Assist (VCA) |
|---|---|
| ------------------- | ------------------------------------------------- |
DEVICE DESCRIPTION 4.
Videa Dental Assist (VDA) software is a cloud-based AI-powered medical device for the automatic detection of the features listed in the Indications For Use statement in dental radiographs. The device itself is available as a service via an API (Application Programming Interface) behind a firewalled network. Provided proper authentication and an eligible bitewing, periapical or panoramic image, the device returns a set of bounding boxes representing the suspect dental finding, historical treatment or normal anatomy detected.
VDA is accessed by the dental practitioner through their dental image viewer. From within the dental viewer the user can upload a radiograph to VDA and then review the results. The device outputs a binary indication to identify the presence of findings for each indication. If findings are present the device outputs the number of findings by finding type and the coordinates of the bounding boxes for each finding. If no findings are present the device outputs a clear indication that there are no findings identified for each indication. The device output will show all findings from one radiograph regardless of the number of teeth present.
The intended users of Videa Dental Assist are trained dental professionals such as dentists and dental hygienists. For the suspect dental findings indications specifically, VDA is intended to be used as an adjunct tool and should not replace a dentist's review of the image. Only dentists that are performing diagnostic activities shall use the suspect dental finding indications.
VDA 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 dental professionals including, but not limited to, dentists and dental hygienists.
Depending on the specific VDA indication for use, the intended patients of Videa Dental Assist are patients 3 years of age and older above with primary, mixed and/or permanent dentition undergoing routine dental visits or suspected of one of the suspected dental findings listed in the VDA indications for use statement above. VDA may be used on eligible bitewing, periapical or panoramic radiographs depending on the indication.
See Table 1 below for the specific patient age group and image modality that each VDA indication for use is designed and tested to meet. VDA uses the images metadata to only show
6
the indications for the patient age and image modalities in scope as shown in Table 1. VDA will not show any findings output for an indication for use that is outside of the patient age and radiographic view scope.
| Videa Dental Assist Indication | Patient Age in Scope | Radiographic View in
Scope |
|----------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Caries | 3 years and older | Bitewing and Periapical |
| Attrition | 3 years and older | Bitewing and Periapical |
| Broken/Chipped | 3 years and older | Bitewing and Periapical |
| Restorative Imperfection | 3 years and older | Bitewing and Periapical |
| Pulp Stone | 12 years of age and
older with permanent
dentition | Bitewing and Periapical |
| Dens Invaginatus | 3 years & older | Bitewing and Periapical |
| Periapical Radiolucency | 22 years of age and
older with permanent
dentition | Periapical only |
| Furcation | 22 years of age and
older with permanent
dentition | Bitewing and Periapical |
| Calculus | 3 years and older | Bitewing and Periapical |
| Widened Periodontal Ligament | 3 years and older | Bitewing and Periapical |
| Historical Treatments: All Indications | 3 years and older | All on Bitewing,
Periapical and
Panoramic |
| Normal Anatomy: All Indications | 12 years and older | 1. Impacted Tooth
2. Mental Foramen
3. Maxillary Tuberosity
On Bitewing, Periapical
& Panoramic |
| Table 1: VDA Indications Scope by Patient Age and Image Modality Type | |||||
|---|---|---|---|---|---|
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| Videa Dental Assist Indication | Patient Age in Scope | Radiographic View in
Scope |
|--------------------------------|----------------------|---------------------------------------------------------------------------------------------|
| | 3 years and older | All other indications are
on Bitewing, Periapical
& Panoramic except: |
| | | 1. 'Mandibular Condyle'
VDA normal anatomy
indication is only on
Panoramic images. |
INTENDED USE/INDICATIONS FOR USE ર.
Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize the following features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older.
Suspected Dental Findings:
- Caries ●
- Attrition ●
- Broken/Chipped Tooth ●
- Restorative Imperfections ●
- Pulp Stones ●
- Dens Invaginatus ●
- Periapical Radiolucency ●
- Widened Periodontal Ligament
- Furcation
- Calculus .
Historical Treatments:
- Crown .
- Filling ●
- Bridge ●
- Post and Core ●
- Root Canal ●
- Endosteal Implant ●
- Implant Abutment ●
- Bonded Orthodontic Retainer ●
- Braces ●
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Normal Anatomy:
- Maxillary Sinus ●
- Maxillary Tuberosity ●
- Mental Foramen ●
- Mandibular Canal ●
- Inferior Border of the Mandible ●
- Mandibular Tori
- Mandibular Condyle ●
- Developing Tooth
- Erupting Teeth
- Non-matured Erupted Teeth
- Exfoliating Teeth
- Impacted Teeth ●
- Crowding Teeth ●
SUBSTANTIAL EQUIVALENCE 6.
Comparison of Indications
Videa Dental Assist is an expansion of the design input scope of Videa Caries Assist. Videa Dental Assist and Videa Caries Assist both analyze dental radiographs and highlight regions of interest in an image viewer. For the VDA suspect dental finding indications, 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 caries regions of interest. Videa Dental Assist's Indication For Use includes additional description on the output of the device which is not a safety or efficacy concern.
Videa Dental Assist contains historical treatment and normal anatomy indications whereas Videa Caries Assist does not. These indications are not intended to be diagnostic aides. They are used for general understanding of features present in a radiograph and to assist the dental practice in patient operations management. These Videa Dental Assist indications do not assess quality or the need for treatment of these features. Therefore for these Videa Dental Assist indications. dental professionals are included in the intended user scope whereas Videa Caries Assist is limited to dentists as the intended user.
The difference in patient ages does not constitute a safety or efficacy concern. Videa Dental Assist artificial intelligence algorithms were trained with that patient population and VideaHealth followed the pediatric medical device guidance document among other standards and guidance documents listed in Section 7 below in the design process. Videa Dental Assist testing has shown to be safe and effective for patients between 3 and 21 years of age with primary, mixed or permanent dentition in the image.
The difference in radiographic views does not constitute a safety or efficacy concern. Videa Dental Assist artificial intelligence algorithms were trained with bitewing, periapical and panoramic radiographs. Videa Dental Assist testing has shown to be safe and effective for bitewing, periapical and panoramic radiographs. Additionally panoramic radiographs are only
9
intended to be used on historical treatment and normal anatomy indications which are not diagnostic aides.
Technological Comparisons
Table 2 compares the key technological feature of the subject devices to the predicate device (Videa Caries Assist, K213795).
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | TBD | K213795 |
| Applicant | VideaHealth, Inc. | VideaHealth, Inc. |
| Device Name | Videa Dental Assist | Videa Caries Assist |
| Classification Regulation | 892.2070 | 892.2070 |
| Product Code | MYN | MYN |
| Image Modality | X-Ray | X-Ray |
| Radiograph View Type | Bitewing Images, Periapical | |
| Images, and Panoramic | ||
| Images. | ||
| Radiograph view type scope is | ||
| Videa Dental Assist indication | ||
| specific. | Bitewing Images | |
| Suspect Dental Findings | ||
| Indications | Caries: Active and Secondary | |
| Caries at all penetration depths | ||
| Additional Suspect Dental | ||
| Findings listed in the Videa | ||
| Dental Assist's Indications For | ||
| Use statement. | Caries: Active and Secondary | |
| Caries at all penetration | ||
| depths. | ||
| Historical Treatment and | ||
| Normal Anatomy | ||
| Indications | Included | Not Included |
| Proposed Device | Predicate Device | |
| Tooth Surface | For the caries indication only: | |
| Proximal, Buccal/Lingual, | ||
| Occlusal, Root, Cervical. | ||
| None of the additional VDA | ||
| 'Suspect Dental Finding' | ||
| indications are specific to a | ||
| tooth surface. | Caries: Proximal, | |
| Buccal/Lingual, Occlusal, | ||
| Root, Cervical. | ||
| Clinical Output | Message indicating if and | |
| how many findings were | ||
| detected for each enabled | ||
| Videa Dental Assist's | ||
| indication for use. | ||
| All Videa Dental Assist's | ||
| indications use a set of | ||
| togglable bounding boxes | ||
| around suspected areas of | ||
| interest. | Message indicating if and | |
| how many carious lesions | ||
| were detected. | ||
| Set of togglable bounding | ||
| boxes around suspected | ||
| lesions. | ||
| Patient Population | Patients ≥ 3 years of age. | |
| Patient age range is Videa | ||
| Dental Assist indication | ||
| specific. | Adults ≥ 22 years of age | |
| Intended User | Dental professionals | US licensed dentists |
| Development Technology | Supervised Deep Learning | Supervised Deep Learning |
| Image Source | X-Ray Sensor | X-Ray Sensor |
| Image Viewing | Image Viewer | Image Viewer |
Table 2: Device Comparison Table
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PERFORMANCE DATA 7.
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.
Among others, the following standards and guidance documents were used during the Videa Dental Assist design, development, and testing.
- ISO 14971:2019 Application of Risk Management to Medical Devices. ●
- AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artificial ● Intelligence and Machine Learning
- IEC 62304 Edition 1.1 2015-06 Consolidated Version: Medical Device Software -● Software Life Cycle Processes
- Good Machine Learning Practice for Medical Device Development: Guiding Principles . October 2021.
- . FDA Premarket Assessment of Pediatric Medical Devices Guidance Document (March 24. 2014)
Bench Testing
A Standalone Performance Assessment was conducted to measure and report the performance of Videa Dental Assist by itself, in the absence of any interaction with a dental professional in identifying the regions of interest for that specific indication. All suspect dental finding, historical treatment and normal anatomy VDA indications were in scope. The dataset was 1.445 radiographs collected from more than 35 US sites that were ground-truthed by three US board-certified dentists. The patients in the dataset were 18% female and 17% male, 16% other and 48% unknown. There were N=17 sensor manufacturers in the study and 8 sensor manufacturers had enough samples to perform generalizability statistical analysis on. Those image sensors were: AirTechniques, Carestream, Dexis, Gendex, Kavo, Schick, PaloDex Group, and Sirona. Tables 3 and 4 describe the distribution of the two significant design input expansions between Videa Dental Assist and the predicate Videa Caries Assist; patient age and radiographic view.
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| Subject Age
| (Years) | Percentage |
|---|---|
| 3 - 11 | 13% |
| 12 - 21 | 15% |
| 22 - 40 | 19% |
| 41 - 60 | 19% |
| 61 and older | 16% |
| Unknown | 18% |
Table 3: Demographic breakdown by age
All images, regardless of patient age, were classified as being primary dentition only, mixed dentition and permanent dentition only.
Table 4: Image breakdown bv radiographic view
| Radiographic
| View | Percentage |
|---|---|
| Bitewing | 45% |
| Periapical | 43% |
| Panoramic | 12% |
Tables 5, 6 and 7 contain the sensitivity and specificity for all Videa Dental Assist indications from the bench study. All of these sensitivity and specificity results met their acceptance criteria.
All of VDA indications' standalone performance was assessed against the following potential patient, device input and image confounders: age, gender, image dentition type, radiograph view type, image quality, imaging sensor manufacturer, bit-depth, image size, and image clinic acquisition location among others.
Additionally VDA indication-specific standalone performance was assessed against the following potential subject and image confounders:
- Caries type, severity, location and specific tooth dentition type ●
- Periapical radiolucency type
- Crown material type ●
- Filling material type
- Onlay or inlay material type
- Bridge material type
- Root canal material type ●
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The bench study results were:
- . All VDA historical treatment and normal anatomy indications that were included in the indications for use statement above met their sensitivity and specificity acceptance criteria. All specificity values for all historical treatment and normal anatomy indications were above their acceptance criteria regardless of their prevalence rates.
- All VDA suspect dental findings indications met their sensitivity and specificity acceptance criteria with the exception of caries specificity. Caries specificity was the only to not pass the target however performed well enough to still pass the clinical study
Additional statistical analysis were performed for each VDA indication including the VDA's false positive fraction rate, non-lesion fraction, and positive predictive value.
Generalizability was observed for all confounders and limitations were listed in the Instructions For Use where necessary. The generalizability analysis results and related information including a list of types (such as material types) are in the Videa Dental Assist Instructions For Use for users.
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence.
Clinical Testing
A fully crossed, randomized, multiple reader multiple case (MRMC) controlled study was performed to determine whether the diagnostic accuracy of readers aided by VDA is superior to reader accuracy when unaided by VDA, as determined by the AFROC Figure of Merit (AFROC FOM). The hypothesis to be tested is:
Ho: AFROC FOMaided - AFROC FOMumaided ≤ 0
H : AFROC FOMaided - AFROC FOM maided > 0
where AFROC FOMsided is the population-mean AFROC FOM for aided reads, and similarly with AFROC FOMunaided for unaided reads.
All suspect dental finding VDA indications were in scope of the clinical testing was performed on 378 radiographs collected from over 25 US locations spread across the country. US licensed dentists labeled the data and a US licensed dentist adjudicated those labels to establish a reference standard for the study.
There were N=26 readers that participated in the study and reviewed all images with and without VDA AI predictions in a randomized fashion.
The patients in the dataset were 24% female and 21% male, 15% other and 39% unknown. There were N=6 sensor manufacturers that had enough samples to perform generalizability statistical analysis on. Those image sensor manufacturers were: AirTechniques, Carestream, Dexis. Gendex. Kavo. and Schick. Tables 5 and 6 describe the distribution of the study for the
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two significant design input expansions between Videa Dental Assist and the predicate Videa Caries Assist; patient age and radiographic view.
| Subject Age
| (Years) | Percentage |
|---|---|
| 3 - 11 | 28% |
| 12 - 21 | 20% |
| 22 - 40 | 14% |
| 41 - 60 | 14% |
| 61 and older | 8% |
| Unknown | 15% |
Table 5: Demographic breakdown by age
All images, regardless of patient age, were classified as being primary dentition only, mixed dentition and permanent dentition only.
Table 6: Image breakdown by radiographic view
| Radiographic
| View | Percentage |
|---|---|
| Bitewing | 56% |
| Periapical | 44% |
| Panoramic | N/A. Not in |
| scope. |
Table 7 contains the AFROC FOM results for all Videa Dental Assist indications in the clinical study. All of these results met their acceptance criteria.
| Videa Dental Assist
Indication | Average Percentage Improvement With VDA
(VDA Aided vs. Unaided Mean AFROC FOM) |
|-----------------------------------|-----------------------------------------------------------------------------------|
| Attrition | 0.171
(28.5% improvement; p-value 3.3e-16) |
| Broken or Chipped | 0.105
(15.3% improvement; p-value 1.5e-11) |
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| Videa Dental Assist
Indication | Average Percentage Improvement With VDA
(VDA Aided vs. Unaided Mean AFROC FOM) |
|-------------------------------------------|-----------------------------------------------------------------------------------|
| Calculus | 0.163
(23.0% improvement; p-value e-12) |
| Caries | 0.024
(4.3% improvement; p-value 0.0085) |
| Dens Invaginatus | 0.236
(36.8% improvement; p-value 1.9e-9) |
| Furcation | 0.199
(29.7% improvement; p-value 0.00057) |
| Periapical Radiolucency | 0.092
(11.5% improvement;
p-value 0.0072) |
| Pulp Stone | 0.211
(35.4% improvement;
p-value 2.2e-16) |
| Restorative Imperfection | 0.164
(27.9% improvement p-value of