(103 days)
Yes
The device description explicitly states that the software is a "cloud-based AI-powered medical device".
No.
The device is described as radiological semi-automated image processing software intended to aid dental professionals in measurements and visualization, not deliver therapy.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis."
Yes
The device is explicitly described as "Videa Perio Assist (VPA) software" and "a cloud-based AI-powered medical device". It functions as an API and is accessed through existing image viewers, indicating it is a software component that processes data from external sources (radiographs) and provides output, without including any dedicated hardware.
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: Videa Perio Assist is a software device that processes radiological images (X-rays). It analyzes these images to measure bone levels. It does not interact with or analyze biological samples from the patient.
- Intended Use: The intended use is to aid dental professionals in the measurement and visualization of bone levels from radiographs, not to perform diagnostic tests on biological specimens.
Therefore, Videa Perio Assist falls under the category of a medical device that processes medical images, not an In Vitro Diagnostic device.
No
The provided input does not explicitly state that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for 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.
Product codes
QIH
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
X-Ray
Anatomical Site
Tooth interproximal alveolar bone level (mesial and distal bone levels associated with each tooth)
Indicated Patient Age Range
Patients 12 years and above with permanent dentition
Intended User / Care Setting
Trained professionals such as 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: 996 radiographs and 16,131 landmarks.
Data source: Not specified, implies internal testing.
Annotation protocol: Bitewing and periapical radiographs were ground truth labeled across two phases. The Videa Perio Assist measurement results were scored versus ground-truthed landmarks.
Clinical Testing:
Sample size: 189 radiographs and analyzed over 2,350 lines.
Data source: Not explicitly stated, implied to be clinical radiographs.
Annotation protocol: 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
Study type: Non-clinical bench testing.
Sample size: 996 radiographs and 16,131 landmarks.
Standalone Performance:
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%.
Key results: Bench testing demonstrated that the Videa Perio Assist meets performance requirements.
Clinical Testing:
Study type: Clinical Testing.
Sample size: 189 radiographs and analyzed over 2,350 lines.
Standalone Performance:
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 periapical 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.
Key results: Clinical testing demonstrated that the Videa Perio Assist meets performance requirements. No adverse events were observed during the clinical study.
Generalizability:
Statistical analysis by sensors and patient age demonstrated a high level of generalizability in both bench and clinical studies. No sensor manufacturers or models, nor patient age groups, were clear outliers. The device missed acceptance criteria for specificity in Sirona sensors on bitewing radiographs and for 'Patients 61 Years and older' on bitewing radiographs, but this was deemed not a safety or effectiveness concern as it does not impact millimeter accuracy when a prediction is made.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bench Testing:
Acceptance Criteria: A recall greater than 82%, A precision greater than 82%.
Results for bitewing radiographs: recall of 94.4% and precision of 84.3%.
Results for periapical radiographs: recall of 91.9%, precision of 79.1% for CEJ-ABL subgroup study.
Clinical Testing:
Acceptance Criteria: A sensitivity greater than 82%, A specificity greater than 81%, A mean absolute error less than 1.5mm.
Results for bitewing radiographs: sensitivity of 92.8%, specificity of 89.4% and mean absolute error below the thresholds.
Results for periapical radiographs: sensitivity of 88.3%, specificity of 87.0% and mean absolute error below the thresholds.
Clinical Performance Metrics by Radiographic View Type and Line Type:
Bitewing CEJ->ABL: Met acceptance criteria for Sensitivity, Specificity, Mean Absolute Error.
Periapical All: Met acceptance criteria for Sensitivity, Specificity, Mean Absolute Error.
Periapical CEJ->ABL: Met acceptance criteria for Sensitivity, Mean Absolute Error. Did not meet acceptance criteria for Specificity.
Periapical CEJ->RT: Met acceptance criteria for Sensitivity, Specificity, Mean Absolute Error.
Periapical ABL->RT: Met acceptance criteria for Sensitivity, Specificity, Mean Absolute Error.
Predicate Device(s)
K210187 Overjet Dental Assist (Overjet, Inc.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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) |
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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.