(246 days)
The PlaniMax Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. 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 the PlaniMax 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.
The PlaniMax Orthodontic Software for dental retainers and dental cast for sequential aligners is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models , virtual planning of orthodontic treatments by simulating tooth movements , and design of orthodontic appliances based on 3D scanned orthodontic models.
The provided text describes the regulatory clearance of the PlaniMax Orthodontic Software but does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in a quantitative sense as typically seen with performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Ortho System from 3ShapeA/S, K171634) through a comparison of:
- Indications for Use
- Technological Characteristics
- Performance Testing (Non-Clinical)
- Software Validation Test Results
Therefore, the acceptance criteria outlined are primarily qualitative, focusing on functional equivalence and safety rather than quantitative performance metrics.
Here's an attempt to structure the answer based on the provided text, acknowledging the limitations in scope of the original document:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The PlaniMax Orthodontic Software's regulatory clearance is based on demonstrating substantial equivalence to a predicate device, the Ortho System (K171634). The "acceptance criteria" can therefore be inferred as meeting the functional and technical characteristics of the predicate device, along with successful software verification and validation.
1. Table of Acceptance Criteria and Reported Device Performance
| Category / Acceptance Criteria (Inferred from comparison to predicate) | Reported Device Performance (PlaniMax) | Comparison Result / Status |
|---|---|---|
| Indications for Use | "The PlaniMax Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. 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 the PlaniMax 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." | Similar: The key difference noted is that PlaniMax's virtual appliance design options specifically include dental casts, which may be used for sequential aligner trays or retainers, whereas the predicate listed "Custom Metal Bands, Export of Models, Indirect Bonding Transfer Media." This difference is deemed "similar" and not to impact substantial equivalence. |
| Technology Features | • Stand Alone Software Module• Imports Digital Patient Scans• Can be used to design Dental Casts• Useful for Diagnosis, treatment planning, and CAD design• Virtual Planning of tooth movement• Supports STL Files | Same. |
| Minimum Hardware/Software Requirements | • OS: Windows 7 32-bit or later• RAM: 4 GB• Monitor Resolution: 1024 X 768• Video Card Memory: 1 GB• Hard Drive Space: 100 GB• CPU: Intel Core i3 or equivalent• Network: Network Internet connection• Mouse: Any Mouse with scrolling wheel or button | Similar: PlaniMax has slightly lower minimum requirements for OS (32-bit Windows 7 vs. 64-bit Windows 7, 8, 10), RAM (4 GB vs. 8 GB), Monitor Resolution (1024x768 vs. 1280x800), Hard Drive Space (100 GB vs. 250 GB), and CPU (Core i3 vs. Core i5). This is stated to have "No effect to the indications for use." |
| Supported Anatomic Structures | Maxilla/Mandible | Both devices support Maxilla/Mandible. |
| Intended Use Features (Managing data, Study Material) | Managing Patient and case base data: YesCollection of study material: YesAlignment of study material: YesMeasuring study material: YesAnalyzing Study material: YesTreatment Simulation: YesVirtual Appliance Design: YesCreating, editing, deleting and copying patient data: YesCreating, editing, deleting and copying case data: YesSurface scan for intraoral scanner: YesSurface scan from STL file: YesCT image data (DICOM): No (Predicate: Yes)2D overlay (PNG, JPG, BMP): Yes | Mostly Same/Similar: PlaniMax does not support CT image data (DICOM) or aligning surface scan and CT images or DICOM scan segmentation, unlike the predicate which supports DICOM input and alignment. This difference is not presented as an impediment to substantial equivalence, implying it does not affect the core intended uses common to both. |
| Intended Use Features (Alignment) | Aligning surface scan and CT image: No (Predicate: Yes)Aligning Cephalometric Images: YesAlignment of 2D overlays: YesAbility to check/adjust DICOM visibility: No (Predicate: Yes)DICOM scan Segmentation: No (Predicate: No) | Mostly Same/Similar: Differences in DICOM support as noted above. |
| Intended Use Features (Measurement & Analysis) | 2D Measurement tool box: Yes3D Measurement tool box: YesArch shape: YesWire length: YesTooth width: YesBolton: YesSpace Analysis: YesOverjet/Overbite: YesOcclusion Map: Yes | Same. |
| Intended Use Features (Treatment Simulation & Appliance Design) | 2D & 3D simulation: YesVirtual Appliance Design: YesOrthodontic Appliance Search: No (Predicate: Yes)Orthodontic Appliance Virtual Preparation: YesOrthodontic Appliance Design: YesOrthodontic appliance Export: Yes | Mostly Same/Similar: PlaniMax does not have an "Orthodontic Appliance Search" feature, which the predicate has. This difference is not presented as affecting substantial equivalence. |
| Non-Clinical Testing / Software Validation | "Software, hardware, and integration 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 11, 2005). 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 PlaniMax to be substantially equivalent to the reference devices." | Met: The non-clinical testing and software validation were deemed sufficient by the FDA to demonstrate safety and effectiveness for substantial equivalence. No specific quantitative performance metrics from these tests are provided. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a clinical performance study with patient data. The evaluation was primarily based on a comparison to a predicate device and software verification/validation. No patient data sample size for a test set is mentioned. Data provenance (country of origin, retrospective/prospective) is therefore not applicable to the documentation provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a test set requiring expert-established ground truth for performance evaluation with patient data.
4. Adjudication method for the test set
Not applicable, as no described test set with ground truth adjudication is present in the document.
5. 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
No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence based on technical and functional comparison and non-clinical software testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire device, the "PlaniMax Orthodontic Software," is a standalone software tool. The non-clinical testing and software validation would broadly cover its standalone performance and functionality as compared to the predicate, but specific quantitative performance metrics (e.g., accuracy of a particular measurement vs. ground truth) are not provided. The phrase "standalone software module" is listed under technology features.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical software validation, the "ground truth" would implicitly be defined by the expected behavior and outputs derived from the software requirements and design specifications, which are validated against during testing. There is no mention of clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient images) being used for performance evaluation in this 510(k) summary.
8. The sample size for the training set
Not applicable. The document describes a software product, but it does not mention training sets, implying it's not an AI/ML-based device that learns from a dataset in the typical sense for performance characterization in this document. If it uses AI, the development methods are not detailed.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned in the provided text.
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December 22, 2020
Choice Biotech Inc. Tyler Kuo RD Vice President Rm. C. 4F. No.13. Nanke 3rd Rd., Xinshi Dist. Tainan City, 74147 Taiwan
Re: K201036
Trade/Device Name: PlaniMax Orthodontic Software Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN Dated: July 20, 2020 Received: July 27, 2020
Dear Tyler Kuo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Michael E. Adjodha, M.ChE. Assistant 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) K201036
Device Name PlaniMax
Indications for Use (Describe)
The PlaniMax Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are based 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 PlaniMax 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) | |
|---|---|
| ------------------------------------------------- | -- |
X 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/0 description: The image shows the logo for CHOICE Biotech. The word "CHOICE" is written in a stylized font, with the "O" replaced by a circle with a plus sign inside. To the right of "CHOICE" is the word "Biotech", with some smaller Chinese characters above it. The logo is in a dark color, possibly black or dark blue, against a white background.
510(k) Summary
This summary of 510(k) safety and effectiveness information in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR 807.92. The assigned 510(k) number is_K201036
| Submitter: | CHOICE BIOTECH INC.Rm. C, 4F, No.13, Nanke 3rd Rd., Xinshi Dist.,Tainan City 74147, TaiwanPhone: +886-6-505-7289Fax: +886-6-505-7301 |
|---|---|
| Contact Person: | Tyler Kuo / RD Vice PresidentEmail: tylerkuo@mail.wearechoice.comPhone: +886-6-505-7289 |
| Date Prepared: | December 21st, 2020 |
| Proprietary Name: | PlaniMax Orthodontic Software |
| Common Name: | Orthodontic Plastic Bracket (Software) |
| CFR Classification: | 21 CFR 872.5470 |
| Device Class: | II |
| Product Code: | PNN |
| Panel: | Dental |
| Primary Predicate: | Ortho System from 3ShapeA/S (K171634) |
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Device Description:
The PlaniMax Orthodontic Software for dental retainers and dental cast for sequential aligners is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models , virtual planning of orthodontic treatments by simulating tooth movements , and design of orthodontic appliances based on 3D scanned orthodontic models.
Indications for Use:
The PlaniMax Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. 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 the PlaniMax 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.
Summary of the technological characteristics:
PlaniMax Orthodontic Software is functionally equivalent to the following predicate device: Ortho System (K171634) cleared January 17th, 2018.
The following tables demonstrates the intended uses and technical characteristics of PlaniMax Orthodontic Software are substantially equivalent to the predicate devices.
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CHOICE
Functional Specification Comparison Table for the PlaniMax Software and Ortho System (K171634) :
| Specification | PlaniMax | Ortho System(K171634) | ComparisonResult |
|---|---|---|---|
| Indications forUse | The PlaniMax Orthodontic Softwareis indicated for use as a front-endsoftware tool for management oforthodontic models, systematicinspection, detailed analysis,treatment simulation and virtualappliance design options, includingdental casts, which may be used forsequential aligner trays or retainers.These applications are based on 3Dmodels of the patient's dentitionbefore the start of an orthodontictreatment. It can also be appliedduring the treatment to inspect andanalyze the progress of the treatment.It can be used at the end of thetreatment to evaluate if the outcome isconsistent with the planned/desiredtreatment objectives.The use of the PlaniMaxrequires 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. | The 3Shape Ortho System™ isintended for use as a medical front-end device providing tools formanagement of orthodontic models,systematic inspection, detailedanalysis, treatment simulation andvirtual appliance design options(Custom Metal Bands, Export ofModels, Indirect Bonding TransferMedia) based on 3D models of thepatient's dentition before the start ofan orthodontic treatment. It can also beapplied during the treatment to inspectand analyze the progress of thetreatment. It can be used at the end ofthe treatment to evaluate if theoutcome is consistent with theplanned/desired treatment objectives.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 in theuse of the software. | Similar.Compare to thepredicate device,the virtualappliance designoptions ofPlaniMax isincluding dentalcasts, whichmay be used forsequentialaligner trays orretainers. |
| TechnologyFeatures | • Stand Alone Software Module• Imports Digital Patient Scans• Can be used to design Dental Casts• Useful for Diagnosis, treatmentplanning, and CAD design• Virtual Planning of toothmovement• Supports STL Files | • Stand Alone Software Module• Imports Digital Patient Scans• Can be used to design Dental Casts• Useful for Diagnosis, treatmentplanning, and CAD design• Virtual Planning of toothmovement• Supports STL Files | Same. |
| MinimumHardware/SoftwareRequirements | • OS: Windows 7 32-bit or later• RAM: 4 GB• Monitor Resolution: 1024 X768• Video Card Memory: 1 GB• Hard Drive Space: 100 GB• CPU: Intel Core i3 orequivalent• Network: Network Internetconnection• Mouse: Any Mouse withscrolling wheel or button | • OS: Windows 7, 8 or 10 64-bit• RAM: 8 GB• Monitor Resolution: 1280 X800• Video Card Memory: 1 GB• Hard Drive Space: 250 GB• CPU: Intel Core i5 orequivalent• Network: Network Internetconnection• Mouse: Any Mouse withscrolling wheel or button | Similar. Noeffect to theindications foruse. |
| Feature | PlaniMax | Ortho System(K171634) | |
| Supported anatomic | 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 | |
| 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 | |||
| Surface scan for intraoral scanner | Yes | Yes | |
| Surface scan from STL file | Yes | Yes | |
| CT image data (DICOM) | No | Yes | |
| 2D overlay (PNG, JPG, BMP) | Yes | Yes | |
| Alignment of study material | |||
| Aligning surface scan and CT image | No | Yes | |
| Aligning Cephalometric Images | Yes | Yes | |
| Alignment of 2D overlays | Yes | Yes | |
| Ability to check/adjust DICOM visibility | No | Yes | |
| DICOM scan Segmentation | No | No | |
| Measuring study material | |||
| 2D Measurement tool box | Yes | Yes | |
| 3D Measurement tool box | 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 | |
| Feature | PlaniMax | Ortho System(K171634) | |
| Occlusion Map | Yes | Yes | |
| Treatment Simulation | |||
| 2D & 3D simulation | Yes | Yes | |
| Virtual Appliance Design | |||
| Orthodontic Appliance Search | No | Yes | |
| Orthodontic Appliance Virtual Preparation | Yes | Yes | |
| Orthodontic Appliance Design | Yes | Yes | |
| Orthodontic appliance Export | Yes | Yes |
The PlaniMax Software has the same intended uses and technical characteristics as the Ortho
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CHGICE智慧
System (K171634):
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Non-Clinical Testing:
Software, hardware , and integration 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 11, 2005).
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 PlaniMax to be substantially equivalent to the reference devices.
Clinical Testing:
Clinical testing is not a requirement and has not been performed.
Conclusion:
Based on comparison of indications for use, technological features, performance testing, and software validation test results, the PlaniMax Orthodontic Software is found to be substantially equivalent to the predicate device.
§ 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.