(270 days)
Not Found
Yes
The device description explicitly states it features an "AI-powered Focus Area Detection algorithm" and mentions "supervised machine learning".
No
This device is a Computer-Assisted Detection (CADe) device designed to analyze radiographs and identify dental findings. It does not provide treatment or therapy.
Yes
The device analyzes intraoral radiographs to identify and localize dental findings such as caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at the margin of an existing restoration, and bone loss, and these detected focus areas can be converted to diagnostic findings by the user. The "Intended Use / Indications for Use" section explicitly states "DTX Studio Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings." Additionally, the "Clinical Performance Assessment" section describes how the device aids in increasing the "diagnostic detection and localization performance of dentists for dental findings."
Yes
The device description and performance studies focus solely on the software's analysis of existing intraoral radiographs. There is no mention of any accompanying hardware or hardware components being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states that DTX Studio Clinic analyzes intraoral radiographs, which are images of the teeth and surrounding structures. It does not analyze blood, urine, tissue, or any other biological sample.
- The intended use is for analyzing images. The device is described as a "computer assisted detection (CADe) device that analyses intraoral radiographs". This is consistent with medical imaging analysis, not in vitro diagnostics.
- The output is based on image features. The device identifies and localizes dental findings based on the visual information in the radiographs.
In summary, DTX Studio Clinic is a medical device used for the analysis of medical images (radiographs), not for testing biological samples. Therefore, it falls under the category of medical imaging software or a CADe device, not an In Vitro Diagnostic.
No
The provided input does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
DTX Studio Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings, which include caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at margin of an existing restoration and bone loss.
The DTX Studio Clinic CADe functionality is indicated for the concurrent review of bitewing and periapical radiographs of permanent teeth in patients 15 years of age or older.
Product codes
MYN
Device Description
DTX Studio Clinic features an AI-powered Focus Area Detection algorithm which analyzes intraoral radiographs for potential dental findings or image artifacts. The detected focus areas can be converted afterwards to diagnostic findings after approval by the user. The following dental findings can be detected by the device:
- Caries: Caries is defined as caries, showing as area with radiographically lower density on a tooth, but does not include occlusal secondary caries under dental fillings.
- Discrepancy at margin of an existing restoration: A discrepancy at margin is defined as radiographically visible discontinuities (gaps. overhangs) between outline/margin of dental restoration (e.g, fillings, inlays or crowns/bridges) and remaining tooth substance, also called as
misfit',poor fit' or `not-perfectly seated'. Note that non-radiopaque cement/bonding material may radiographically appear as a space. - Periapical radiolucency: A periapical radiolucency is defined as a radiolucent area or radiographic observation of low bone density related to the apical part of the root. A widening of the periodontal ligament is not included.
- . Root canal filling deficiency: The root canal filling appears radiographically too short (more than 2mm from the radiographic apex) and/or too small in diameter, or the root filling is not radiographically homogenously dense (e.g., with visible void in root filling or gaps between filling and root dentin), or otherwise show absence of radioopaqueness.
- . Bone loss: Bone loss is defined as a radiographically lower density of the marginal bone and/or a lower crest of the alveolar bone compared to what is considered normal for healthy natural dentition. Healthy natural dentition refers to teeth that have not experienced any marginal bone loss and have an alveolar bone that covers the root of the tooth. It is indicated by a focus area annotation, however, the size of the rectangular bounding box is not indicative of the amount of bone loss.
- Calculus: Calculus is a hard, mineralized form of dental plaque that is visible on radiographic images as radiopaque material attached to the tooth surface.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
intraoral radiographs, bitewing, periapical radiographs
Anatomical Site
Not Found
Indicated Patient Age Range
patients 15 years of age or older
Intended User / Care Setting
Dentists
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
A standalone performance assessment was conducted to measure the performance of the AIpowered Focus Area Detection algorithm by itself, in the absence of any interaction with a dentist. A separate dataset of 452 adult IOR images including both bitewings and periapical radiographs, was assembled. The dataset was ground-truthed by a group of 10 dental practitioners followed by an additional expert review. In total the data set contained 1767 dental findings (365 caries, 110 periapical radiolucencies, 145 root canal filling deficiencies, 216 discrepancies at restoration margins, 588 bone loss instances and 343 calculus instances).
The dataset contains 216 periapical and bitewing IOR images that were acquired in US-based dental offices by either sensor or photostimulable phosphor plates. The images were obtained from both male (43%) and female (42%) patients with ages ranging between 15 and 93 years (average age 49.4). The ground truth was defined by 4 ground truthers with a 3 out of 4 consensus. All ground truthers have at least 20 years of experience in reading of dental x-rays.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Standalone Performance:
- Study type: Standalone performance assessment
- Sample size: 452 adult IOR images
- Key results:
- Overall sensitivity: 0.79 (95% CI [0.74, 0.84])
- Overall precision: 0.45 (95% CI [0.40, 0.50])
- Mean Dice score: in range of 53.5% to 71.9%
- Standalone sensitivity per dental finding type:
- CARIES: 0.70 [0.65, 0.75]
- PERIAPICAL RADIOLUCENCY: 0.68 [0.59, 0.77]
- ROOT CANAL FILLING DEFICIENCY: 0.95 [0.91, 0.99]
- DISCREPANCY AT RESTORATION MARGIN: 0.82 [0.77, 0.87]
- BONE LOSS: 0.78 [0.75, 0.81]
- CALCULUS: 0.80 [0.76, 0.84]
Clinical Performance Assessment:
- Study type: Retrospective fully crossed, multi reader, multi case study
- Sample size: 216 periapical and bitewing IOR images, read by 30 readers
- AUC: Increase of the AUC from the control arm to the study arm to be highly significant (p
§ 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.
0
March 28, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
Nobel Biocare AB % Wim Vrydag QA/RA Manager Nobel Biocare c/o Medicim NV Stationsstraat 102 Mechelen, 2800 BELGIUM
Re: K221921
Trade/Device Name: DTX Studio Clinic 3.0 Regulation Number: 21 CFR 892.2070 Regulation Name: Medical Image Analyzer Regulatory Class: Class II Product Code: MYN Dated: February 24, 2023 Received: February 27, 2023
Dear Wim Vrydag:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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) K221921
Device Name DTX Studio Clinic 3.0
Indications for Use (Describe)
DTX Studio Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings, which include caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at margin of an existing restoration and bone loss.
The DTX Studio Clinic CADe functionality is indicated for the concurrent review of bitewing and periapical radiographs of permanent teeth in patients 15 years of age or older.
| 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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Image /page/3/Picture/1 description: The image contains the logo for Nobel Biocare. On the left side of the logo is a red symbol that looks like the letter N. To the right of the symbol is the company name, "Nobel Biocare", in black font. The word "Nobel" is on top of the word "Biocare", and there is a trademark symbol next to the word "Biocare".
510(k) Summary
I. Submitter
Submitted by: Nobel Biocare c/o Medicim NV Stationsstraat 102 Mechelen, 2800, Belgium Establishment Registration No. 3005739655 Telephone: +32 15 44 32 00 Facsimile: +32 15 44 32 09 Email: wim.vrydag@envistaco.com
Submitted for: Nobel Biocare AB Vastra Hamngatan 1 Göteborg, SE-411 17, Sweden Establishment Registration No. 9611992 Date Prepared: March 28, 2023
II. Device
Name of Device: DTX Studio Clinic 3.0 Manufacturer: Nobel Biocare AB Common or Usual Name: Medical Image Analyzer Regulation Number: 21 CFR 892.2070 Classification Name: Medical Image Analyzer Product Code: MYN Device Class: II
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary Predicate:
Predicate Device: Videa Caries Assist Predicate 510(k): K213795 Company: Videa Health, Inc Common or Usual Name: Medical Image Analyzer Regulation Number: 21 CFR 892.2070 Classification Name: Medical Image Analyzer
4
Nobel Biocare AB Traditional 510(k)
Image /page/4/Picture/1 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with the trademark symbol next to "Biocare".
Product Code: MYN Device Class: II
Secondary Predicate:
Predicate Device: Second Opinion Predicate 510(k): K210365 Company: Pearl Inc. Common or Usual Name: Medical Image Analyzer Regulation Number: 21 CFR 892.2070 Classification Name: Medical Image Analyzer Product Code: MYN Device Class: II
IV. Device Description
DTX Studio Clinic features an AI-powered Focus Area Detection algorithm which analyzes intraoral radiographs for potential dental findings or image artifacts. The detected focus areas can be converted afterwards to diagnostic findings after approval by the user. The following dental findings can be detected by the device:
- Caries: Caries is defined as caries, showing as area with radiographically lower density on a tooth, but does not include occlusal secondary caries under dental fillings.
- Discrepancy at margin of an existing restoration: A discrepancy at margin is defined as radiographically visible discontinuities (gaps. overhangs) between outline/margin of dental restoration (e.g, fillings, inlays or crowns/bridges) and remaining tooth substance, also called as
misfit',poor fit' or `not-perfectly seated'. Note that non-radiopaque cement/bonding material may radiographically appear as a space. - Periapical radiolucency: A periapical radiolucency is defined as a radiolucent area or radiographic observation of low bone density related to the apical part of the root. A widening of the periodontal ligament is not included.
- . Root canal filling deficiency: The root canal filling appears radiographically too short (more than 2mm from the radiographic apex) and/or too small in diameter, or the root filling is not radiographically homogenously dense (e.g., with visible void in root filling or gaps between filling and root dentin), or otherwise show absence of radioopaqueness.
- . Bone loss: Bone loss is defined as a radiographically lower density of the marginal bone and/or a lower crest of the alveolar bone compared to what is considered normal for healthy natural dentition. Healthy natural dentition refers to teeth that have not experienced any marginal bone loss and have an alveolar bone that covers the root of the tooth. It is indicated by a focus area annotation, however, the size of the rectangular bounding box is not indicative of the amount of bone loss.
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Image /page/5/Picture/1 description: The image contains the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside it. To the right of the square is the text "Nobel Biocare" in black font, with the word "Nobel" stacked on top of the word "Biocare". The "TM" symbol is located to the upper right of the word "Biocare".
- Calculus: Calculus is a hard, mineralized form of dental plaque that is visible on radiographic images as radiopaque material attached to the tooth surface.
V. Indications for Use
DTX Studio Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings, which include caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at margin of an existing restoration and bone loss.
The DTX Studio Clinic CADe functionality is indicated for use by dentists for the concurrent review of bitewing and periapical radiographs of permanent teeth in patients 15 years of age or older.
VI. Substantial Equivalence
Comparing indications:
DTX Studio Clinic 3.0 and the predicate devices (Videa Caries Assist (K213795) and Second Opinion (K210365)) all analyze dental intraoral radiographs and annotate suspected areas of interest for the dentist to review. Both DTX Studio Clinic 3.0 and the primary predicate, Videa Caries Assist perform concurrent detection of dental findings. DTX Studio Clinic identifies four types of dental findings: caries, apical lesions (periapical radiolucency), root canal defect, marginal defect (discrepancy at the margin), bone loss and calculus, while the primary predicate, Videa Caries Assist, only identifies caries. However, the secondary predicate, Second Opinion, also identifies four different types of dental findings: identifies 4 types of dental findings, caries, discrepancy at the margin, calculus, and periapical radiolucency. Although the pathological dental findings differ, they all share the same intended use, as they are all computer-assisted detection devices that accept dental radiographs as inputs and use supervised machine learning to identify and highlight ROIs. The subject device, is intended for a patient population of patients from the age of 15 years where as the primary predicate, Videa Caries Assist is intended only for intraoral radiographs of patients older than 22 years. The secondary predicate, Second Opinion is intended for a patient population of patients from the age of 12 years. Both DTX Studio Clinic and Second Opinion support the dentist on the review of both bitewing and periapical radiographs. The differences in Indications for Use do not constitute a new indented use, as the subject and primary predicate are both intended to assist the dentifying suspected areas of interest in intraoral radiographs
Technical comparisons
The comparison of the technological features of DTX Studio Clinic and the predicate devices can be found in table 1.
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Image /page/6/Picture/1 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside it, followed by the words "Nobel Biocare" in black text. The word "Nobel" is on the top line, and "Biocare" is on the bottom line with a trademark symbol.
DTX Studio Clinic 3.0 K221921
Table 1: Comparison of DTX Studio Clinic to Predicate Devices
| Criteria | DTX Studio Clinic
3.0
(Subject Device)
(K221921) | Videa Caries Assist
Predicate Device
(Primary)
(K213795) | Pearl - Second
Opinion
Secondary Predicate
Device
(K210365) | Comments |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Information | | | | |
| Regulation # | 892.2070 | 892.2070 | 892.2070 | Same |
| Classification Name | Medical Image
Analyzer | Medical Image
Analyzer | Medical Image
Analyzer | Same |
| Device Class | II | II | II | Same |
| Product Code | MYN | MYN | MYN | Same |
| Indication for Use / Intended Use | | | | |
| Indications for Use
Statement | DTX Studio Clinic is a
computer assisted
detection (CADe)
device that analyses
intraoral radiographs
to identify and localize
dental findings, which
include caries,
calculus, periapical
radiolucency, root
canal filling
deficiency,
discrepancy at the | Videa Caries Assist is
a computer-assisted
detection (CADe)
device that analyzes
intraoral radiographs
to identify and localize
carious lesions. Videa
Caries Assist is
indicated for use by
board licensed dentists
for the concurrent
review of bitewing
(BW) radiographs | Second Opinion® is a
computer aided
detection ("CADe")
software to identify
and mark regions in
relation to suspected
dental findings which
include Caries,
Discrepancy at the
margin of an existing
restoration, Calculus,
Periapical
radiolucency, Crown | Similar to Primary
Predicate, except for
some additional dental
findings and age of
patient population.
Patient population is
same as the Secondary
Predicate, but the
differences do not
raise a concern of
substantial |
| margin of an existing
restoration and bone
loss. The DTX Studio
Clinic CADe
functionality is
indicated for use by
dentists for the
concurrent review of
bitewing and
periapical radiographs
of permanent teeth in
patients 15 years of
age or older. | | acquired from adult
patients aged 22 years
or older. | (metal, including
zirconia & non-metal),
Filling (metal & non-
metal), Root canal,
Bridge and Implants. It
is designed to aid
dental health
professionals to review
bitewing and
periapical radiographs
of permanent teeth in
patients 12 years of
age or older as a
second reader. | equivalence as
demonstrated by
performance testing |
| | | | | |
| Technological Characteristics | | | | |
| Focus Area Detection | Automated Detection
Output
Message indicating if
and how many dental
findings are detected | Automated Detection
Output
Message indicating if
and how many carious
lesions were detected. | Automated Detection
Output
Bounding boxes | Same as Primary
Predicate |
| | Set of togglable
bounding boxes
around suspected
dental findings | Set of togglable
bounding boxes
around suspected
lesions | | |
| | Dental Findings
Caries, periapical
radiolucency, root | Dental Findings
Caries | Dental Findings
Caries, discrepancy at
the margin, calculus | Similar to Predicate
Devices, additional
dental findings are |
| | canal filling
deficiency,
discrepancy at the
margin of an existing
restoration, bone loss
and calculus | and periapical
radiolucency | identified but the
differences do not
raise a concern of
substantial
equivalence as
demonstrated by
performance testing.
Same as Primary
Predicate | |
| Reader workflow
Concurrent Reading | Reader workflow
Concurrent Reading | Reader workflow
Second reader | | |
| Algorithm | Algorithm | Algorithm | Same | |
| Supervised machine
learning | Supervised machine
learning | Supervised machine
learning | | |
| Patient population
Permanent teeth in
patients 15 years of
age or older | Patient population
Adults ≥ 22 years | Patient population
Permanent teeth in
patients 12 years of
age or older | Similar to Predicate
Devices, the
differences do not
raise a concern of
substantial
equivalence as
demonstrated by
performance testing. | |
| Radiographs
Bitewing and
Periapical | Radiographs
Bitewing | Radiographs
Bitewing and
Periapical | Same as Secondary
Predicate, the
differences do not
raise a concern of
substantial
equivalence as
demonstrated by
performance testing. | |
| Intended user | Dentists | US license dentists | Dentists | Same |
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Image /page/7/Picture/1 description: The image contains the logo for Nobel Biocare. The logo consists of a stylized red letter "N" on the left, followed by the words "Nobel Biocare" in black font on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
DTX Studio Clinic 3.0
K221921
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Image /page/8/Picture/1 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with an "N" shape inside of it on the left. To the right of the square is the text "Nobel Biocare" in black font. The word "Nobel" is on top of the word "Biocare".
DTX Studio Clinic 3.0
K221921
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Image /page/9/Picture/1 description: The image contains the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with the trademark symbol next to the word Biocare.
VII. Performance Data
DTX Studio Clinic 3.0 is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485:2016 Standards. This device is in conformance with the applicable parts of IEC 62304:2006+A1:2015 standards. Design Control Activities. including risk management following the ISO 14971:2019, verification/validation testing, were conducted and are included in this submission.
The performance of the subject device was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation. This documentation includes testing which demonstrates that the requirements for the features have been met. Software documentation for Moderate Level of Concern and description of respective verification and validation activities, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included as part of this submission.
Software Validation
Software verification and validation testing was conducted on the subject device 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".
Standalone Performance
A standalone performance assessment was conducted to measure the performance of the AIpowered Focus Area Detection algorithm by itself, in the absence of any interaction with a dentist. A separate dataset of 452 adult IOR images including both bitewings and periapical radiographs, was assembled. The dataset was ground-truthed by a group of 10 dental practitioners followed by an additional expert review. In total the data set contained 1767 dental findings (365 caries, 110 periapical radiolucencies, 145 root canal filling deficiencies, 216 discrepancies at restoration margins, 588 bone loss instances and 343 calculus instances).
The standalone overall sensitivity was found to be 0.79 (with 95% CI [0.74, 0.84]), standalone sensitivity per dental finding type is listed in Table 2. Overall precision was found to be 0.45 (with 95% CI [0.40, 0.50]). The standalone localization accuracy was studied by measuring the intersection over union (IoU) and the Dice score (see Table 2) of the detected findings. Mean Dice score was found to be in range of 53.5% to 71.9%, indicating a high overlap between the AI detected findings and the ground truth annotations.
| DENTAL FINDING TYPE | SENSITIVITY | MEAN IOU (%) | MEAN DICE (%) |
|---|---|---|---|
| CARIES | 0.70 [0.65, 0.75] | 58.6 [56.2, 60.9] | 71.9 [69.9, 74.0] |
| PERIAPICAL | |||
| RADIOLUCENCY | 0.68 [0.59, 0.77] | 48.9 [44.9, 52.9] | 63.7 [59.9, 67.5] |
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Image /page/10/Picture/1 description: The image shows the logo for Nobel Biocare. On the left is a red square with a stylized "N" inside. To the right of the square is the text "Nobel Biocare" in black font, with a trademark symbol next to the word "Biocare".
| ROOT CANAL FILLING
| DEFICIENCY | 0.95 [0.91, 0.99] | 51.9 [49.3, 54.6] | 66.9 [64.3, 69.4] |
|---|---|---|---|
| DISCREPANCY AT | |||
| RESTORATION MARGIN | 0.82 [0.77, 0.87] | 48.4 [46.0, 50.7] | 63.5 [61.3, 65.8] |
| BONE LOSS | 0.78 [0.75, 0.81] | 44.8 [43.4, 46.3] | 60.1 [58.7, 61.6] |
| CALCULUS | 0.80 [0.76, 0.84] | 55.5 [53.7, 57.3] | 70.1 [68.4, 71.7] |
Table 2: Standalone performance results of the Focus Area Detection algorithm for the 6 dental finding types. For each measure the 95% CI range is listed.
Clinical Performance Assessment
A retrospective fully crossed, multi reader, multi case study was performed to demonstrate that the aid of IOR Focus Area Detection algorithm increases the diagnostic detection and localization performance of dentists for dental findings in IORs. The primary endpoint was a significant Area Under the Curve (AUC) increase in the study arm compared to the control arm. The AUC figure of merit value was obtained based on an AFROC (Alternative Free Response Receiver Operating Characteristic) curve analysis.
The dataset contains 216 periapical and bitewing IOR images that were acquired in US-based dental offices by either sensor or photostimulable phosphor plates. The images were obtained from both male (43%) and female (42%) patients with ages ranging between 15 and 93 years (average age 49.4). The ground truth was defined by 4 ground truthers with a 3 out of 4 consensus. All ground truthers have at least 20 years of experience in reading of dental x-rays.
The IORs were read by 30 readers in a fully crossed design, with half of the readers starting with unaided reading and the other half with aided reading by the support of the AI introduced to DTX Studio Clinic 3.0. After a wash-out period of 4 weeks, the reader groups were swapped, and reading was repeated.
The analysis showed the increase of the AUC from the control arm to the study arm to be highly significant (p