(118 days)
Not Found
Unknown
The description mentions "automatically detect the teeth cervical margins, teeth numbering and mesio distal orientations" and "Automatically generate virtual setups suitable for aligners treatment". While these tasks could potentially be performed using AI/ML, the document does not explicitly state that AI/ML is used for these functions. It could be rule-based automation. There is no mention of AI, DNN, or ML in the text, nor is there a description of training or test sets typically associated with AI/ML development.
No.
The device is a software tool for analysis, simulation, and virtual design, which aids in treatment planning and evaluation but does not directly provide therapy or interact physically with the patient for therapeutic purposes.
Yes
The device is intended for "detailed analysis" and "inspect and analyze the progress of the treatment," which implies determining the nature or condition of a disease or other health problem through examination. While it also has treatment simulation and design functions, its role in analysis of the patient's dentition and treatment progress makes it a diagnostic device.
Yes
The device is explicitly described as "CS Model+ is a software" and its function is to process data from other medical devices (intraoral and extraoral scanners) and output data (STL or PLY files) for use in subsequent fabrication processes, which are stated to be outside the scope of the manufacturer's process. The description focuses solely on software functionalities and does not mention any accompanying hardware components manufactured or provided by the submitter.
Based on the provided text, 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.
- CS Model+ Function: CS Model+ is a software tool that works with 3D models of a patient's dentition (teeth and surrounding structures). It is used for analysis, simulation, and design related to orthodontic treatment. It does not analyze biological samples from the patient's body.
- Input Modality: The input modalities are intraoral and extraoral scanners, which capture physical structures, not biological samples.
- Intended Use: The intended use is for managing, analyzing, simulating, and designing related to orthodontic treatment based on 3D models of the teeth.
Therefore, CS Model+ falls under the category of a medical device, specifically software used in the practice of orthodontics, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CS Model+ is intended for use as a front-end software tool for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design options, including dental casts and orthodontic appliances. These applications are 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 CS Model+ requires the user to have the necessary training and domain knowledge in the practice of orthodontics.
Product codes
PNN
Device Description
CS Model+ is a software that allows practitioners to apply software imaging tools for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design. CS Model+ allows design of virtual models, also known as virtual dental casts. Those can be exported as STL or PLY files which may be used for fabrication of orthodontic models (dental casts). Then, which may be used to fabricate sequential aligner trays or retainers. The production of physical models and the other fabrication processes, such as thermoforming of aligner, is out of scope of Carestream Dental's manufacturing process. Those fabrication processes are done by the user and is under their sole control and responsibility.
It is the responsibility of the user to ensure:
- that all production machines and materials used are suitable for producing models or appliances for orthodontic purposes.
- that all production machines and materials used are FDA cleared.
CS Model+ is intended to be used with the following Carestream Dental's digital imaging devices including:
- Intraoral scanners;
- Extraoral devices with 3D object modality.
CS Model+ allows healthcare professionals to do the following:
- Display digital 2D or 3D views of digital 3D models;
- Adjust the color and opacity of digital 3D models;
- Make indicative measurements of digital 3D models;
- Print and export images of digital 3D models;
- In a digital model, automatically detect the teeth cervical margins, teeth numbering and mesio distal orientations;
- Generate an orthodontic report;
- Create virtual setups;
- Automatically generate virtual setups suitable for aligners treatment;
- Make automatic and customizable export of virtual models;
- Manage the intermediate steps;
- Make refinement during treatment.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Surface scan from intra-oral scanner, DICOM, PNG, JPG, STL
Anatomical Site
Maxilla / Mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The use of CS Model+ requires the user to have the necessary training and domain knowledge in the practice of orthodontics.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing: Prior to release, software verification and validation testing of the CS Model+ have been performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005). Testing confirmed that CS Model+ is stable and operating as designed. The risk management procedures have been applied to the development of the software and the risks identified have been mitigated and reduced to acceptable levels. All test results have been reviewed and approved, showing the CS Model+ software to be substantially equivalent to the primary predicate Ortho System™ (K171634).
Clinical testing: Clinical testing is not a requirement and has not been performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 and 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.
April 2, 2020
Trophy Marie-Pierre Labat-Camy Global Regulatory Affairs Senior Manager 4 Rue F. Pelloutier Croissy-Beaubourg, Marne La Vallee Cedex 2, 77435 France
Re: K193390
Trade/Device Name: CS Model+ Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN Dated: March 4, 2020 Received: March 6, 2020
Dear Marie-Pierre Labat-Camy:
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
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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,
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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Indications for Use
510(k) Number (if known)
K193390
Device Name CS Model+
Indications for Use (Describe)
CS Model+ is intended for use as a front-end software tool for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design options, including dental casts and orthodontic appliances. These applications are 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 CS Model+ requires the user to have the necessary training and domain knowledge in the practice of orthodontics.
| 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)
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510(K) SUMMARY
(As per 21 CFR 807.92)
1) Date 510(k) Summary prepared
April 2nd, 2020
2) Contact information
a) Submitter information
Contact: Ms. Marie-Pierre LABAT-CAMY Phone: +33 (0) 1 64 80 85 26 Address: Trophy 4 Rue F. Pelloutier - Croissy-Beaubourg 77435 Marne La Vallée, Cedex 2 France
b) United Stated Sales Representative (U.S. Designated Agent)
Contact: Mr. Sonny T. Nguyen Phone: +1 (470) 481-4619 Address: Carestream Dental LLC 3625 Cumberland Boulevard, Suite 700, Atlanta, GA USA 30339
3) Device Identification
Trade/Device Name: CS Model+ Regulation Number: 21 CFR 872.5470 Common Name: Orthodontic Plastic Brackets Regulatory Class: II Product code: PNN
4) Primary Predicate
We consider the CS Model+ to be similar in design, composition and function to the following device, introduced into commercial distribution after May 28, 1976:
Trade/Device Name: Ortho System™ 510(k) Number: K171634 510(k) Submitter/holder: 3Shape A/S
Ortho System™ has been found to be substantially equivalent through the 510(k) premarket notification process.
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Traditional 510(k) Submission for CS Model+
5) Device description
CS Model+ is a software that allows practitioners to apply software imaging tools for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design. CS Model+ allows design of virtual models, also known as virtual dental casts. Those can be exported as STL or PLY files which may be used for fabrication of orthodontic models (dental casts). Then, which may be used to fabricate sequential aligner trays or retainers. The production of physical models and the other fabrication processes, such as thermoforming of aligner, is out of scope of Carestream Dental's manufacturing process. Those fabrication processes are done by the user and is under their sole control and responsibility.
It is the responsibility of the user to ensure:
- that all production machines and materials used are suitable for producing models or । appliances for orthodontic purposes.
- that all production machines and materials used are FDA cleared. -
CS Model+ Indication for Use is the following:
CS Model+ is intended for use as a front-end software tool for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design options, including dental casts and orthodontic appliances. These applications are 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 CS Model+ requires the user to have the necessary training and domain knowledge in the practice of orthodontics.
CS Model+ is intended to be used with the following Carestream Dental's digital imaging devices including:
- -Intraoral scanners;
- -Extraoral devices with 3D object modality.
CS Model+ allows healthcare professionals to do the following:
- -Display digital 2D or 3D views of digital 3D models;
- Adjust the color and opacity of digital 3D models; -
- -Make indicative measurements of digital 3D models;
- Print and export images of digital 3D models; -
- -In a digital model, automatically detect the teeth cervical margins, teeth numbering and mesio distal orientations;
- -Generate an orthodontic report;
- Create virtual setups; -
- -Automatically generate virtual setups suitable for aligners treatment;
- Make automatic and customizable export of virtual models; -
- -Manage the intermediate steps;
- -Make refinement during treatment.
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6) Indications for Use
CS Model+ is intended for use as a front-end software tool for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design options, including dental casts and orthodontic appliances. These applications are 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 CS Model+ requires the user to have the necessary training and domain knowledge in the practice of orthodontics.
Comparison of Indications for Use
The indication for use for the CS Model+ is similar to the primary predicate device Ortho System™ (K171634); the differences do not alter the intended use of the device. Therefore, the CS Model+ software can be considered substantially equivalent to its predicate device.
7) Substantial Equivalence
a) Summary of the technological characteristics
CS Model+ is a standalone software which has the following PC/laptop hardware requirements:
| PC/ Laptop hardware requirements comparison | ||
|---|---|---|
| Comparison Areas | CS Model+ | Ortho System™ |
| OS | Windows 10 64-bit | Windows 7, 8 or 10 64-bit |
| RAM | 8 GB | 8 GB |
| Monitor Resolution | 1024x768 minimum | 1280x800 or similar |
| Video Card Memory | 1 GB | 1 GB |
| Available HDD Space | 10 GB | 250 GB |
| CPU | 2,4 GHz Intel Duo Core | Intel Core i5 or equivalent |
| Network | Network Internet connection | Network Internet connection |
| Mouse | With the wheel button | With the wheel button |
| Intended use and technical characteristics comparison | ||
| Comparison Areas | CS Model+ | Ortho System™ |
| Destination | ||
| Supported anatomic areas | Maxilla / Mandible | Maxilla / Mandible |
| 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 |
| Treatment simulation | Yes | Yes |
| Virtual appliance design | Yes | Yes |
| Supported PC formats | ||
| Operating System | Windows | Windows |
| Managing patient and case base data | ||
| Creating, editing, deleting and copying patient data | Yes | Yes |
| Creating, editing, deleting and copying case data | Yes | Yes |
| Collection of study material / | ||
| Acquisition Data Formats Support | ||
| Standalone software module | Yes | Yes |
| Surface scan from intra-oral scanner | Yes | Yes |
| Image data | DICOM, PNG, JPG, STL | DICOM, PNG, JPG, STL |
| Alignment of study material | ||
| Alignment of 2D overlays (e.g. ideal arch) | Yes | Yes |
| Measuring study material | ||
| 2D measurement toolbox | Yes | Yes |
| 3D measurement toolbox | Yes | Yes |
| Analyzing study material | ||
| Arch shape | Yes | Yes |
| Tooth width | Yes | Yes |
| Bolton | Yes | Yes |
| Space analysis | Yes | Yes |
| Overjet/overbite | Yes | Yes |
| Occlusion map | Yes | Yes |
| Treatment simulation | ||
| 3D simulation | Yes | Yes |
| Virtual appliance design | ||
| Orthodontic appliance virtual preparation | Yes | Yes |
| Orthodontic appliance design | Yes | Yes |
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Traditional 510(k) Submission for CS Model+
CS Model+ has the same intended use and technical characteristics as Ortho System™ (K171634) from 3Shape A/S:
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b) Nonclinical testing
Prior to release, software verification and validation testing of the CS Model+ have been performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005). Testing confirmed that CS Model+ is stable and operating as designed.
The risk management procedures have been applied to the development of the software and the risks identified have been mitigated and reduced to acceptable levels.
All test results have been reviewed and approved, showing the CS Model+ software to be substantially equivalent to the primary predicate Ortho System™ (K171634).
c) Clinical testing
Clinical testing is not a requirement and has not been performed.
8) Conclusion
Based on a comparison of intended use, indications, principle of operations, features and technical data, and the test results, CS Model+ is found to be substantially equivalent to the primary predicate Ortho System™ (K171634).