(185 days)
RAYDENT SW is a software designed to assist dental professionals in planning patient treatment devices. The software performs simulations based on patient images, allowing reference to treatment plans, and is used as a tool to design treatment devices based on 3D mesh data. Treatment devices include prosthetic devices (Veneer, Crown, Bridge, In/Onlay) and orthodontic devices (Clear Aligner).
To use RAYDENT SW, users must have the necessary education and domain knowledge in orthodontic practice and receive dedicated training in the use of the software.
RAYDENT is a software that provides tools to simulate treatment plans based on patient images generated by compatible scanners and design treatment devices based on appropriate three-dimensional images. It allows dental offices to acquire patient data in conjunction with software on compatible imaging equipment and utilize the acquired images to create treatment plans and devices for skilled dentists and oral and maxillofacial specialists.
The document K233625 is a 510(k) Premarket Notification for the device "RAYDENT SW," a software designed to assist dental professionals in planning patient treatment devices. As such, the document provides information on the device's intended use, comparison to predicate devices, and a summary of performance testing. However, it does NOT include detailed information about acceptance criteria or a specific study proving the device meets those criteria, particularly not in the context of an AI/ML-enabled medical device performance study.
The document states that RAYDENT SW includes "Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices: YES" in its comparison table (Page 7). However, the "Performance Testing" section (Page 9) does not describe an AI/ML-specific performance study with acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop evaluation. It merely states that "Software, hardware, and integration and validation testing was performed in accordance with the FDA Guidance Document 'Guidance for the Content of Premarket Submissions for Device Software Functions' and 'Guidance for the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions'." It then concludes that "All test results have been reviewed and approved, showing the RAYDENT SW to be substantially equivalent to the predicate devices."
Therefore, based on the provided text, I cannot extract the information required to answer your prompt about the acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.
To answer your specific points:
- A table of acceptance criteria and the reported device performance: Not found in the provided document. The document mentions general validation testing but no specific performance metrics or acceptance criteria for an AI component.
- Sample sized used for the test set and the data provenance: Not found.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not found.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not found. The document explicitly states "Clinical testing is not a requirement and has not been performed" (Page 9), implying no such MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed for an AI component. The general performance testing is mentioned, but without specifics for the AI.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not found.
- The sample size for the training set: Not found.
- How the ground truth for the training set was established: Not found.
The document focuses on substantiating equivalence primarily through comparison of indications for use, technological characteristics, and general software/hardware validation, rather than an in-depth AI/ML performance study.
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May 16, 2024
Huh Soo Ji RA Specialist 1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu Yongin-si, Gyeonggi-do 16882 SOUTH KOREA
Re: K233625
Trade/Device Name: Raydent SW Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, NOF Dated: April 19, 2024 Received: April 19, 2024
Dear Huh Soo Ji:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Michael E. Adodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT 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) K233625
Device Name RAYDENT SW
Indications for Use (Describe)
RAYDENT SW is a software designed to assist dental professionals in planning patient treatment devices. The software performs simulations based on patient images, allowing reference to treatment plans, and is used as a tool to design treatment devices based on 3D mesh data. Treatment devices include prosthetic devices (Veneer, Crown, Bridge, In/Onlay) and orthodontic devices (Clear Aligner).
To use RAYDENT SW, users must have the necessary education and domain knowledge in orthodontic practice and receive 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) Summary — K233625
1. 510(k) Summary
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
2. Date: May 13, 2024
3. Administrative Information
| Applicant | Ray Co., Ltd. | ||
|---|---|---|---|
| Address | 1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu, Yongin-si,16882, Korea | ||
| Manufacturer | Name | Ray Co., Ltd. | |
| Address | 1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu, Yongin-si,16882, Korea | ||
| Tel | +82-31-605-1000 | ||
| Fax | +82-2-6280-5534 | ||
| Contact Person | Name | Sooji Huh | |
| sooji.huh@raymedical.co.kr |
4. Device Information
| Trade/Proprietary Name | RAYDENT SW |
|---|---|
| Common Name | Orthodontic Software |
| Device | Orthodontic plastic bracket |
| Regulation Number | 21 CFR 872.5470 |
| Class | 2 |
| Product Code | PNN, NOF |
| Review Panel | Dental |
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| Parameter | Predicate Device | Reference Device | Reference Device | |
|---|---|---|---|---|
| Device Name | Ortho System™ | CEREC Ortho Software | ChairsideCAD | |
| Manufacturer | 3Shape A/S | Dentsply Sirona | EXOCAD GMBH | |
| 510(K) Number | K180941Traditional 510k | K171122Traditional 510k | Exemption fromPremarket Notification | |
| Classificationname | Orthodontic PlasticBracket | Orthodontic PlasticBracket | System, OpticalImpression, ComputerAssisted Design AndManufacturing(Cad/Cam) Of DentalRestorations | |
| Regulationnumber | 872.5470 | 872.5470 | 872.3661 | |
| Primary productcode | PNN(Orthodonticsoftware) | PNN(Orthodonticsoftware) | NOF | |
| Parameter | Proposed Device | Predicate Device | Reference Device | Reference Device |
| Manufacturer | RAY Co., Ltd. | 3Shape A/S | Dentsply Sirona | EXOCAD GMBH |
| Device name | RAYDENT SW | Ortho System™ | CEREC Ortho Software | ChairsideCAD |
| 510(K) Number | (Traditional 510K) | K180941(Traditional 510K) | K171122(Traditional 510K) | Exemption from PremarketNotification |
| Common Name | Orthodontic Software | Orthodontic Software | Orthodontic Software | System, Optical Impression,Computer Assisted Design AndManufacturing (Cad/Cam) OfDental Restorations |
| ClassificationProduct Code | PNN, NOF | PNN | PNN | NOF |
| Indicationsfor use | RAYDENT SW is a softwaredesigned to assist dentalprofessionals in planning patienttreatment and designing treatmentdevices. The software performssimulations based on patientimages, allowing reference totreatment plans, and is used as atool to design treatment devicesbased on 3D mesh data.Treatment devices includeprosthetic devices (Veneer,Crown, Bridge, In/Onlay) andorthodontic devices (ClearAligner).To use RAYDENT SW, usersmust have the necessaryeducation and domain knowledgein orthodontic or prosthodonticpractice and receive dedicatedtraining in the use of the software. | Ortho System™ for dentalretainers and dental cast forsequential aligners is intended foruse as a medical front-end deviceproviding tools for management oforthodontic models, systematicinspection, detailed analysis,treatment simulation and virtualappliance design options basedon 3D models of the patient'sdentition before the start of anorthodontic treatment.The use of the Ortho System™requires 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. | CEREC Ortho Software isintended for use with image dataacquired from handheld intra oral3D cameras and desktoplaboratory scanners to create 3Dvirtual models to be used for dataacquisition and modeling analysisfor orthodontic patients andconditions. The CEREC OrthoSoftware 3D model data can beexported to orthodontic designsoftware to aid in the design oforthodontic appliances. | ChairsideCAD is a softwaredevice intended to support thedesign of dental restorations suchas inlays, onlays, crowns,copings, veneers, bridges,pontics, provisionals and bitesplints via a 3D CAD tool. Thedesign is based on suitable 3Dscans of the patient's dentalanatomy produced by acompatible scanner. The softwaregenerates geometrical output ofthe design for manufacturing oncompatible CAM systems.ChairsideCAD is intended to beused by trained professionals indental practices and is not to beused for any purpose other thanthe design of dental restorationsor bite splints, nor is it to be usedfor designing dental abutments. |
5. Predicate device
6. Device Description
RAYDENT is a software that provides tools to simulate treatment plans based on patient images generated by compatible scanners and design treatment devices based on appropriate threedimensional images. It allows dental offices to acquire patient data in conjunction with software on compatible imaging equipment and utilize the acquired images to create treatment plans and devices for skilled dentists and oral and maxillofacial specialists.
7. Indication for use
RAYDENT SW is a software designed to assist dental professionals in planning patient treatment and designing treatment devices. The software performs simulations based on patient images, allowing reference to treatment plans, and is used as a tool to design treatment devices based on 3D mesh data. Treatment devices include prosthetic devices (Veneer, Crown, Bridge, In/Onlay) and orthodontic devices (Clear Aligner).
To use RAYDENT SW, users must have the necessary education and domain knowledge in orthodontic or prosthodontic practice and receive dedicated training in the use of the software.
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8. Comparison with predicate device
The following table provides the summary of the technological characteristics of RAYDENT SW compared to the predicate device
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| Minimum Hardware/SoftwareRequirements | CPU : Intel Core i5RAM : 16GBGPU : NVIDIA GeForce RTX2060 6GBStorage : 1TB SSDResolution : 1920 x 1080LAN : 1Gbps EthernetOS : Windows 10 x64 or Windows11 x64 | CPU : Intel Core i5 or equivalentRAM : 8GBGPU : 1GBStorage : 250GBResolution : 1280 x 800 or similarLAN : Network Internet connectionOS : Windows 7, 8 or 10 64-bit | CPU : Intel QuadCore 1.6 GHzprocessorRAM : 8GBGPU : NVidia or AMD graphicscard 1 GBStorage : 250GB hard diskOS : Windows 7, 64-bit | CPU : Quad-CoreRAM : 4GBGPU : 1GBResolution : 1920 x 1080OS : Windows 10 64 bit |
|---|---|---|---|---|
| Support Images | DICOM, 2D and 3D images (PLY,OBJ, STL) | DICOM, STL, JPG, BMP, PNG | Intra-oral scan data, STL | DICOM, 2D and 3D images(STL,OFF, OBJ, PLY) |
| Supported anatomicareas | Maxilla, Mandible | Maxilla, Mandible | Maxilla, Mandible | Maxilla, Mandible |
| Functionality | - Acquisition of oral topographyimage data- Creation of virtual 3D virtualdental models- Alignment of 3D virtual dentalmodels- Measurement of 3D virtualdental models- Analysis of 3D virtual dentalmodels- Orthodontic treatment simulation- Virtual orthodontic appliancedesign- Exporting of 3D virtual model,analysis and treatment case data- Prosthesis design | - Acquisition of oral topographyimage data- Creation of virtual 3D virtualdental models- Alignment of 3D virtual dentalmodels- Measurement of 3D virtualdental models- Analysis of 3D virtual dentalmodels- Orthodontic treatment simulation- Virtual orthodontic appliancedesign- Exporting of 3D virtual model,analysis and treatment case data | - Acquisition of oral topographyimage data- Creation of virtual 3D virtualdental models- Alignment of 3D virtual dentalmodels- Measurement of 3D virtualdental models- Analysis of 3D virtual dentalmodels- Exporting of 3D virtual modeland analysis data | - Design of dental restorations- Geometrical output of the designfor manufacturing on compatibleCAM systems |
| Analysis Features | - Define occlusion- Tooth segmentation- Measure length and angle in thefrontal and lateral direction- Define the tooth and set thetooth axis- Tooth width measurements- Bolton analysis- IPR | - Occlusal mapping- Tooth and gingivaseparation/segmentation- Definition of dental arch shapeand length- Tooth width measurements- Bolton's analysis- Space analyses | - Occlusal mapping- Tooth and gingivaseparation/segmentation- Definition of dental arch shapeand length- Tooth width measurements- Bolton's analysis- Nance and Moyer spaceanalyses | N/A |
| Artificial Intelligenceand MachineLearning (AI/ML)-Enabled MedicalDevices | YES | N/A | YES | N/A |
| Prosthesis design | Crown | N/A | N/A | Crown |
| Pontic | Pontic | |||
| Bridge | Bridge | |||
| Veneer | Veneer | |||
| Inlay/Onlay | Inlay/Onlay | |||
| Temporary Denture | Provisional restorations | |||
| eModel | Bite splints | |||
| - | Coping | |||
| - | Abutment |
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The product is principally just the same as in the previous 510(k) #K180941, #K171122 and the ChairsideCAD.
The complete of differences of the subject device to the predicate #K180941 and #K171122 devices are as follows
-
Minimum Hardware/Software Requirement
-
Support images
-
Prosthesis design
The orthodontic treatment simulation and virtual orthodontic appliance design capabilities are the $4.180941. Additionally, the prosthesis design capabilities are the same of the ChairsideCAD.
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9. Performance Testing
Software, hardware, and integration and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Device Software Functions" and "Guidance for the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.
All test results have been reviewed and approved, showing the RAYDENT SW to be substantially equivalent to the predicate devices.
The documentation level of RAYDENT SW corresponds to basic documentation level based on the intended use, design, and risk of device software functionality.
10. Clinical Testing
Clinical testing is not a requirement and has not been performed.
11. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Ray Co., Ltd. concludes that the newly RAYDENT SW is substantially equivalent to the predicate device as described herein.
§ 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.