The Clevaligner software is intended for use as a medical device standalone software, providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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 Clevaligner Software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

Device Description

Clevaligner Software imports patient 3-D digital scans and provides the orthodontic treatment planning of the patient under dental professional supervision.

The Clevaligner Software performs the automatic segmentation of the 3-D digital scans, achieves an automatic design of an ideal arch form, which is approved by orthodontists using a 2D software interface.

The Clevaligner Software provides an initial to ideal final stage treatment plan, with each step of the treatment plan path presented in the 3D software interface.

Every 3D digital model from the path treatment plan, generated by the Clevaligner Software, can be exported for fabrication of orthodontic appliances, either to an orthodontic laboratory or directly to orthodontic appliance manufacturers for further use in orthodontic treatment.

AI/ML Overview

The provided text does not contain the detailed acceptance criteria and study results in the format requested. While it refers to "Software verification and validation testing" and states that "All test results met acceptance criteria," it does not specify what those acceptance criteria were or what the reported device performance was against those criteria.

Specifically, the document is a 510(k) summary for the Clevaligner Software (V1.0.0), a Class II orthodontic software. It focuses on demonstrating substantial equivalence to a predicate device (SoftSmile, Inc. Vision K212770).

Here's a breakdown of what can be extracted and what is missing based on your request:

Information Extracted from the Document:

Device Name: Clevaligner Software (V1.0.0)
Intended Use: "intended for use as a medical device standalone software, providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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." (Page 6)
Type of Study (Non-Clinical): Software testing, including verification and validation, conducted in accordance with IEC 62304 and FDA Guidance Documents ("General Principles of Software Validation" and "Cybersecurity in Medical Devices"). An "aligner manufacturing validation" was also performed to demonstrate that the digital aligners planned by the software match the fabrication of aligner trays/retainers with an acceptable level of accuracy. (Page 10)
Clinical Testing: "Clinical testing has not been performed and is not required since the proposed device, Clevaligner Software, is a stand-alone medical device software which is used without direct patient contact." (Page 10)
Documentation Level: Basic Documentation level as per FDA Guidance for the Content of Premarket Submissions for Device Software Functions. (Page 10)
Cybersecurity Analysis: Performed in accordance with FDA Guidance. (Page 10)

Missing Information (Crucial for your request):

A table of acceptance criteria and the reported device performance: This is the most significant missing piece. The document merely states "All test results met acceptance criteria" (Page 10) but does not list them or the specific performance metrics achieved.
Sample size used for the test set and the data provenance: Not specified for the software verification/validation tests. For the "aligner manufacturing validation," it mentions "digital aligners treatment planned" but no specific sample size or origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
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 done, as it states clinical testing was not performed. The software is for "virtual design" and "treatment planning," not direct interpretation by humans that would be assisted by AI in the diagnostic sense.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, non-clinical software testing was done, but the specific metrics are not detailed. The "aligner manufacturing validation" also seems to be a standalone performance check.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified for the software testing. For the aligner manufacturing validation, the "ground truth" implicitly would be the physical accuracy of the 3D printed models compared to the software's digital design, but the method for assessing this "acceptable level of accuracy" isn't detailed.
The sample size for the training set: Not mentioned. This device likely uses machine learning for features like "automatic segmentation" and "automatic design of an ideal arch form," but no details on training data are provided.
How the ground truth for the training set was established: Not mentioned.

Conclusion:

The provided FDA 510(k) summary confirms the device's regulatory clearance based on substantial equivalence, but it does not provide the specific technical details of the acceptance criteria nor the performance data that would typically be found in a detailed study report. The document indicates that thorough non-clinical software testing and validation were performed, and all acceptance criteria were met, but the specific details of these criteria and the results are not included in this summary. The "aligner manufacturing validation" hints at a performance metric related to accuracy in aligner fabrication, but again, without specific numbers or methods.

Summary

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January 11, 2024

Clevaligner Ltd % Ora Msika QA/RA Manager Rs Ness Hamelacha street 45 Netanya, 4250574 Israel

Re: K233616

Trade/Device Name: Clevaligner Software (V1.0.0) Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN. LLZ Dated: November 10, 2023 Received: November 13, 2023

Dear Ora Msika:

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.

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"

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(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 OS 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).

Sincerely.

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices

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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

Submission Number (if known)

K233616

Device Name

Clevaligner Software (V1.0.0)

Indications for Use (Describe)

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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K233616

510(k) SUMMARY

In accordance with 21 C.F.R. § 807.92 the following summary of information is provided:

DATE: November 10, 2023

SUBMITTER

Clevaligner LTD King George St 20 9426208 Jerusalem Israel

CONTACT PERSON

Jonathan Tabet Chief Technology Officer (СТО) Email: jonathan@clevaligner.com King George St 20 9426208 Jerusalem Israel T: +972-534719048

DEVICE

PROPRIETARY NAME: Clevaligner Software V1.0.0

COMMON NAME: Orthodontic Software

CLASSIFICATION REGULATION NAMES: Orthodontic plastic bracket CLASSIFICATION REGULATION: 21 C.F.R. § 872.5470

DEVICE CLASS: II

PRIMARY PRODUCT CODE: PNN: Orthodontic Software (Under 21 C.F.R. 872.5470)

ADDITIONAL PRODUCT CODE: LLZ: System, Image Processing, Radiological (under 21 C.F.R. 892.2050)

Page 1 of 7

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For the planned and proposed 510(k), the Clevaligner Software will have a primary predicate device as SoftSmile, Inc. Vision (K212770).

DEVICE DESCRIPTION

Clevaligner Software imports patient 3-D digital scans and provides the orthodontic treatment planning of the patient under dental professional supervision.

The Clevaligner Software provides an initial to ideal final stage treatment plan, with each step of the treatment plan path presented in the 3D software interface.

INDICATIONS FOR USE

Clevaligner Software is intended for use as a medical device standalone software, providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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 Clevaligner Software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed Clevaligner Software has the same indication for use as the legally marketed predicate device to which substantial equivalency is claimed, the SoftSmile,

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Inc. Vision (K212770).

The proposed Clevaligner Software has identical intended use, operational and functional features as the cleared software, SoftSmile, Inc. Vision (K212770). Clevaligner Software uses the same fundamental technology as the legally marketed predicate software, to which substantial equivalency is claimed, the SoftSmile, Inc. Vision. The subject device supports in addition PLY file format whereas the predicate does not.

Table 1 Substantial Equivalence Justification: comparison of technological characteristics with the predicate device

	Clevaligner Software	SoftSmile, Inc. Vision (K212770)(Primary Predicate)
Indication for use	The Clevaligner Software is intendedfor use as a medical devicestandalone, providing tools formanagement of orthodontic models,systematic inspection, detailedanalysis, treatment simulation andvirtual design of a series of dentalcasts, which may be used forsequential aligner trays or retainers,based on 3D models of the patient'sdentition before the start of anorthodontic 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 Clevaligner Softwarerequires the user to have thenecessary training and domainknowledge in the practice oforthodontics, as well to have receiveda dedicated training in the use of thesoftware.	The SoftSmile Vision is intended foruse as a medical front-end deviceproviding tools for management oforthodontic models, systematicinspection, detailed analysis,treatment simulation and virtualdesign of a series of dental casts,which may be used for sequentialaligner trays or retainers, based on3D models of the patient's dentitionbefore the start of an orthodontictreatment. It can also be appliedduring the treatment to inspect andanalyze the progress of thetreatment. It can be used at the endof the treatment to evaluate if theoutcome is consistent with theplanned/desired treatmentobjectives. The use of SoftSmileVision requires the user to have thenecessary training and domainknowledge in the practice oforthodontics, as well to havereceived a dedicated training in theuse of the software.
Intended use	Used by dental professionals inorthodontic treatment planning(before, during, and after treatment)• Management of patients and models• Inspection, measurement, andanalysis of orthodontic models• Treatment simulation	Used by dental professionals inorthodontic treatment planning(before, during, and after treatment)• Management of patients and models• Inspection, measurement,and analysis of orthodontic models• Treatment simulation
	Clevaligner Software	SoftSmile, Inc. Vision (K212770)(Primary Predicate)
	Virtual preparation of dental casts handling and export Provides digital file	Virtual preparation of dental casts, handling and export Provides digital file
Software Environment of Use	Dental office	Dental office
Software Intended User	Dental professional	Dental professional
Intended Patient Population	Patients with malocclusion	Patients with malocclusion
Target Anatomic Area	Maxilla, Mandible	Maxilla, Mandible
Type of Patient Contact	None	None
Principle of Operation	Apply digital imaging tools for use in orthodontic case archiving, treatment planning and CAD design of customized appliances. The system supports the following types of digital data: STL, OBJ, JPG, PNG and PLY. The subject device supports PLY file format whereas the predicate does not.	Apply digital imaging tools for use in orthodontic case archiving, treatment planning and CAD design of customized appliances. The system supports the following types of digital data: STL, OBJ, JPG, BMP, PNG.
Technical attributes	Minimum Requirements: Operating System (OS): Windows 10, 64-bit, Mac OS 10 Browser system: Chrome Version 110, Safari 16 RAM: 8 GB Monitor Resolution: 1920x1440 or similar Graphic Card Memory: Video Card Memory: 2 GB or more discrete graphics card Available HDD Space: 80 GB CPU: IntelCore i3, AMD FX4300 or higher Network:8MB/s	Minimum Requirements: Supported PC formats: Windows 10 64-bit RAM: 4 GB Monitor Resolution: 1280x800 or similar Video Card Memory: 2 GB or more discrete graphics card Available HDD Space: 120 GB or more CPU: IntelCore i3, AMD FX-4300 or higher
Management of patient/case base Data	Allows creating, editing, deleting, copying patient/case data	Allows creating, editing, deleting, copying patient/case data
	Clevaligner Software	SoftSmile, Inc. Vision (K212770)(Primary Predicate)
Collection of Input	• Surface scan for intra-oral scanner• Surface scan from STL or OBJ file• 2D overlay: PNG, JPG	• Surface scan for intra-oral scanner• Surface scan from STL or OBJ file• 2D overlay: PNG, JPG, BMP
Alignment of Input	• Aligning surface scan image• Alignment of 2D overlays (e.g., ideal arch)	• Aligning surface scan image• Alignment of 2D overlays (e.g., ideal arch)
Measurement of Input	3D measurement toolbox	3D measurement toolbox
Analysis of Input	• Arch shape• Tooth width• Space analysis• Overjet/overbite• Occlusion map	• Arch shape• Tooth width• Bolton• Space analysis• Overjet/overbite• Occlusion map
Treatment simulation	3D simulation	3D simulation
Virtual appliance design	• Orthodontic dental cast virtual preparation• Orthodontic dental cast design• Orthodontic dental cast export	• Orthodontic dental cast search• Orthodontic dental cast virtual preparation• Orthodontic dental cast design• Orthodontic dental cast export
Virtual appliance options	Dental casts	Dental casts

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PERFORMANCE DATA

NON-CLINICAL TESTS

Software testing has been conducted in accordance with the software life cvcle processes, as defined in IEC 62304.

Software and integration verification and validation testing were performed in accordance with the FDA Guidance Document "General Principles of Software Validation; Final Guidance for Industry (issued June 11, 2002).

Software verification and validation testing was conducted to ensure that all user needs and performance requirements according to the design inputs are fulfilled. Software verification and validation was conducted to ensure the functionality of the software and to support the safety and effectiveness of the proposed software. The verification and validation of the software has been completed prior to release of the Clevaligner Software.

The testing includes validation of implemented mitigations, related to device hazards identified in the risk management procedures. All test results met acceptance criteria, demonstrating Clevaligner Software performs as intended, raises no new or different questions of safety or effectiveness and is substantially equivalent to the predicate device.

The described approach for testing also includes testing of cybersecurity requirements determined in the cybersecurity analysis.

A cybersecurity analysis was performed in accordance with the FDA Guidance Document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions", issued on September 27, 2023. Clevaligner Software monitors vulnerabilities of the software during lifetime and analyses them in the risk management.

The documentation level for the software was assessed per the FDA Guidance for the Content of Premarket Submissions for Device Software Functions" issued June 14, 2023) and determined to be Basic Documentation level, based on the risks of the software functions in the context of the software intended use.

The test data to verify the performance of Clevaligner Software have been provided. where the results of this testing, combined with the comparison to the predicate device, support substantial equivalence and do not raise any new issues of safety or effectiveness.

All test results have been reviewed and approved, demonstrating Clevaligner is substantially equivalent in terms of safety and effectiveness to the predicate software.

CLINICAL TESTING

Clinical testing has not been performed and is not required since the proposed device, Clevaligner Software, is a stand-alone medical device software which is used without direct patient contact.

However, an aligner manufacturing validation was performed, in order to demonstrate that the digital aligners treatment planned proposed by the Clevaligner Software, matches the fabrication

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of aligner trays or retainers 3D printed from subsequent thermoforming steps with an acceptable level of accuracy.

CONCLUSIONS

The proposed Clevaligner Software is intended to provide virtual design of dental casts, which may be used for sequential aligner trays or retainers such as the predicate device.

Both devices create customized dental appliances based on computer models of the patient's pre-treatment and post-treatment dentition.The minor technological differences between this device and its predicate device raise no new issues of safety or effectiveness. Thus, the Clevaligner Software is found to be substantially equivalent to in terms of safety and effectiveness to the predicate device.

Regulation Number and Section

§ 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.