(207 days)
DIBS by OrthoSelect is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the DIBS by OrthoSelect requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
DIBS by OrthoSelect is a software system used for the management of 3D scanned orthodontic models of the patients' dentition and allows orthodontic measurements, analysis, inspection, and visualization. The primary purpose of DIBS is to allow virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets, and design of orthodontic appliances based on the 3D scanned orthodontic models. Output includes STL files that can be used to make Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). The device has no patient contact. DIBS is a software-only device.
The provided text is a 510(k) Summary for the DIBS (Digital Indirect Bonding System) device. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for a standalone study against a rigorous ground truth.
Here's an analysis based on the information provided, specifically addressing your points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results against a defined ground truth. Instead, it focuses on comparing features and intended use with a predicate device (3Shape Ortho System, K152086) to establish substantial equivalence.
The "PERFORMANCE DATA" section states:
"Medical device verification and validation testing was performed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 2005). Validation was performed in conformity with IEC 62304 - Medical device software - Software lifecycle processes. Documentation was also prepared in accordance to FDA quidance documents, "General Principles of Software Validation" (issued January 2002) and "Off-The-Shelf Software Use in Medical Devices" (issued September 1999)."
This indicates that general software testing and validation were performed to ensure the software functions as intended and safely, but it does not detail specific performance metrics (e.g., accuracy, precision) against a clinical ground truth for the device's functions like "treatment simulation" or "virtual appliance design."
2. Sample Size Used for the Test Set and Data Provenance
The document does not disclose the sample size for any specific clinical or performance test set, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective). The validation described is primarily software validation and verification.
3. Number of Experts and their Qualifications for Ground Truth Establishment
The document does not mention the use of experts to establish ground truth for a test set or their qualifications. The validation mentioned focuses on software functionality rather than clinical accuracy adjudicated by experts.
4. Adjudication Method
No adjudication method is described, as there's no mention of a clinical test set with ground truth established by experts.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through feature comparison and software validation, not on evaluating the improvement of human readers with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
While the device is a "Stand Alone Software," the document does not describe a standalone performance study where the algorithm's output is directly evaluated against a clinical ground truth without human intervention, specifically in terms of its ability to accurately simulate treatment or design appliances. The performance data section refers to general software verification and validation, not a clinical performance study.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any performance evaluation in terms of clinical outcomes, pathology, or expert consensus related to the device's core functions (treatment simulation, appliance design). The validation relates to internal software functionality.
8. Sample Size for the Training Set
The document does not mention any training set size. This implies that the device likely relies on deterministic algorithms and pre-existing models/rules rather than being a machine learning-based device that would require a large training dataset. The software performs calculations and designs based on user input and 3D models.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned, there is no information on how its ground truth would have been established.
Summary of Acceptance Criteria and Study Information:
Based on the provided text, the device's acceptance criteria and the "study" proving it meets them are framed in the context of software verification and validation and demonstration of substantial equivalence to a predicate device, rather than a clinical performance study with specific quantifiable metrics against a clinical ground truth.
- Acceptance Criteria (Implicit from the document's focus):
- The software functions as intended and safely.
- The device manages orthodontic models, enables systematic inspection, detailed analysis, treatment simulation, and virtual appliance design options.
- The features are comparable to the predicate device (3Shape Ortho System K152086).
- No new questions of safety or effectiveness are raised compared to the predicate.
- Reported Device Performance (Implicit):
- The software successfully underwent medical device verification and validation testing according to FDA guidance (May 2005, January 2002, September 1999) and IEC 62304.
- The device performs functions such as managing patient data, collection, alignment, measurement, and analysis of study material, treatment simulation, and virtual appliance design, aligning with the predicate device's capabilities.
- Study Details: The document outlines a comparative analysis against a predicate device (3Shape Ortho System) and detailed software verification and validation. It does not describe a clinical performance study with human readers, specific patient cohorts, or adjudicated ground truth for accuracy metrics.
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April 21, 2020
OrthoSelect, LLC % Carmine Jabri President E.M.M.A International Consulting Group Inc. 27600 Farmington Road, Suite 100 Farmington Hills, Michigan 48334
Re: K192701
Trade/Device Name: DIBS (Digital Indirect Bonding System) Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: March 20, 2020 Received: March 23, 2020
Dear Carmine Jabri:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-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.
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192701
Device Name
DIBS (Digital Indirect Bonding System)
Indications for Use (Describe)
DIBS by OrthoSelect is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the DIBS by OrthoSelect requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
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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510(k) Number (K192701) 510(k) SUMMARY - Traditional 510(k)
A summary of information in accordance with requirements of 21 CFR 807.92.
SUBMITTER'S INFORMATION
| Sponsor: | OrthoSelect, LLC |
|---|---|
| Address: | 831 E 340 S Suite 170American Fork, UT 84003, USA |
| Official Correspondent: | Carmine JabriE.M.M.A International Consulting Group Inc.+1 248.987.4497carmine.jabri@emmainternational.com |
| Date Summary Prepared: | April 20, 2020 |
DEVICE INFORMATION
| Name of Device: | DIBS (Digital Indirect Bonding System) |
|---|---|
| Common Name: | Orthodontic Software |
| Classification Name: | 21 CFR 872.5470 – Orthodontic plastic bracket |
| Product Code: | PNN |
| Secondary ProductCode: | LLZ |
| Device Classification: | Class II |
PREDICATE DEVICE
K152086 - 3Shape A/S - 3Shape Ortho System Primary Predicate Device:
DEVICE DESCRIPTION
DIBS by OrthoSelect is a software system used for the management of 3D scanned orthodontic models of the patients' dentition and allows orthodontic measurements, analysis, inspection, and visualization. The primary purpose of DIBS is to allow virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets, and design of orthodontic appliances based on the 3D scanned orthodontic models. Output includes STL files that can be used to make Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays).
· Farmington Hills, MI · Clearwater, FL · York, PA · Grand Rapids, MI · Worldwide · 248-987-4497 / www.emmainternational.com Page 1 of 6
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The device has no patient contact. DIBS is a software-only device with the following hardware requirements:
| Item | Minimum Requirements |
|---|---|
| OS | Windows 7 or 8 64-bit |
| RAM | 4 GB or more |
| Monitor Resolution | 1280x800 or similar |
| Video Card Memory | 1 GB GeForce |
| Available HDD Space | 250 GB |
| CPU | IntelCore i3 or higher equivalent |
| Network | Network Internet Connection |
| Mouse | With scroll wheel recommended |
· Farmington Hills, MI · Clearwater, FL · York, PA · Grand Rapids, MI · Worldwide · 248-987-4497 / www.emmainternational.com
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INDICATIONS FOR USE
DIBS by OrthoSelect is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the DIBS by OrthoSelect requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
COMPARISON TO PREDICATE DEVICE
DIBS has the same intended uses and is subject to the same regulation as the Ortho System from 3Shape A/S (K152086):
| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| SPONSOR | OrthoSelect | 3Shape |
| TRADE NAME | DIBS | Ortho System |
| 510(k) NUMBER | --- | K152086 |
| PRODUCT CODE | PNN | PNN |
| Secondary Product Code | LLZ | LLZ |
| INDICATIONS FOR USE | DIBS by OrthoSelect isintended for use as a medicalfront-end device providing toolsfor management of orthodonticmodels, systematic inspection,detailed analysis, treatmentsimulation and virtual appliancedesign options (Export ofModels, Indirect BondingTransfer Media) based on 3Dmodels of the patient's dentitionbefore the start of anorthodontic treatment. It can | 3Shape Ortho System isintended for use as a medicalfront-end device providing toolsfor management of orthodonticmodels, systematic inspection,detailed analysis, treatmentsimulation and virtual appliancedesign options (Custom MetalBands, Export of Models,Indirect Bonding TransferMedia) based on 3D models ofthe patient's dentition beforethe start of an orthodontic |
· Farmington Hills, MI · Clearwater, FL · York, PA · Grand Rapids, MI · Worldwide · 248-987-4497 / www.emmainternational.com Page 3 of 6
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E.M.M.A. International Consulting Group, Inc.
| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| SPONSOR | OrthoSelect | 3Shape |
| TRADE NAME | DIBS | Ortho System |
| 510(k) NUMBER | --- | K152086 |
| also be applied during thetreatment to inspect andanalyze the progress of thetreatment. It can be used at theend of the treatment to evaluateif the outcome is consistent withthe planned/desired treatmentobjectives. | treatment. It can also beapplied during the treatment toinspect and analyze theprogress of the treatment. It canbe used at the end of thetreatment to evaluate if theoutcome is consistent with theplanned/desired treatmentobjectives. | |
| The use of the DIBS byOrthoSelect requires the user tohave the necessary training anddomain knowledge in thepractice of orthodontics, as wellas to have received a dedicatedtraining in the use of thesoftware. | The use of the Ortho Systemrequires the user to have thenecessary training and domainknowledge in the practice oforthodontics, as well as to havereceived a dedicated training inthe use of the software. | |
| GENERAL DESCRIPTION | Stand Alone Software | Stand Alone Software |
| SUPPORTED ANATOMICAREAS | Maxilla, Mandible | Maxilla, Mandible |
| PATIENT CONTACT | None | None |
Additionally, DIBS has many of the same features that the predicate device, Ortho System from 3Shape A/S (K152086), has:
| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| OrthoSelect DIBS | 3Shape Ortho System | |
| Intended use | ||
| Managing patient and case base data | Yes | Yes |
| Collection of study material | Yes | Yes |
| Alignment of study material | Yes | Yes |
| Measuring study material | Yes | Yes |
| Analyzing study material | Yes | Yes |
| Managing patient and case base data | ||
| Creating, editing, deleting, and copyingpatient data | Yes | Yes |
· Farmington Hills, MI · Clearwater, FL · York, PA · Grand Rapids, MI · Worldwide · 248-987-4497 / www.emmainternational.com Page 4 of 6
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| Creating, editing, deleting, and copying case data | Yes | Yes |
|---|---|---|
| Collection of study material | Yes | Yes |
| Surface scan for intra-oral scanner | Yes | Yes |
| Surface scan from STL file | Yes | Yes |
| CT image data | No | DICOM |
| 2D overlay | No | PNG, JPG, BMP |
| Alignment of study material | ||
| Aligning surface scan and CT image | No | Yes |
| Aligning cephalometric images | No | Yes |
| Alignment of 2D overlays (e.g., ideal arch) | Yes | Yes |
| Ability to check/adjust DICOM visibility | No | Yes |
| DICOM scan segmentation | No | No |
| Measuring study material | ||
| 2D measurement toolbox | Yes | Yes |
| 3D measurement toolbox | Yes | Yes |
| Analyzing study material | ||
| Arch shape | Yes | Yes |
| Wire length | Yes | Yes |
| Tooth width | Yes | Yes |
| Bolton | Yes | Yes |
| Space analysis | Yes | Yes |
| Overjet/overbite | Yes | Yes |
| Occlusion map | Yes | Yes |
| Treatment simulation | ||
| 2D & 3D simulation | Yes | Yes |
| Virtual appliance design | Yes | Yes |
| Orthodontic appliance search | Yes | Yes |
| Orthodontic appliance virtual preparation | Yes | Yes |
| Orthodontic appliance design | Yes | Yes |
| Orthodontic appliance export | Yes | Yes |
Differences between the features do not affect the safety or effectiveness of DIBS compared to its predicate device.
PERFORMANCE DATA
Medical device verification and validation testing was performed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 2005). Validation was performed in conformity with IEC 62304 - Medical device software - Software lifecycle processes.
· Farmington Hills, MI · Clearwater, FL · York, PA · Grand Rapids, MI · Worldwide · 248-987-4497 / www.emmainternational.com Page 5 of 6
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Documentation was also prepared in accordance to FDA quidance documents, "General Principles of Software Validation" (issued January 2002) and "Off-The-Shelf Software Use in Medical Devices" (issued September 1999).
CONCLUSIONS
DIBS has the same intended use as the predicate device, Ortho System (K152086). Both devices are orthodontic software devices requlated under 21 CFR 872.5470 and are intended to aid in orthodontic treatment planning and allow the export of orthodontic appliance designs.
The predicate 3Shape Ortho System (K152086) is additionally regulated as a Radiological Image Processing System under 21 CFR 892.2050 due to its functionality to utilize CT DICOM images as input. DIBS does not have this functionality, however, this difference does not affect the safety or effectiveness of DIBS.
Based on the comparison between indications for use, technological features, performance testing, and software validation testing, DIBS has been shown to be substantially equivalent to the legally marketed device, Ortho System (K152086).
· Farmington Hills, MI · Clearwater, FL · York, PA · Grand Rapids, MI · Worldwide · 248-987-4497 / www.emmainternational.com Page 6 of 6
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.