3Shape Implant Studio is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation of patient anatomy and dental implant placement.

Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.

Device Description

3Shape Implant Studio® is a stand-alone software device used to pre-operatively plan the placement of a dental implant based on the visualization of a patient's CT image, optionally aligned to an optical 3D surface scan. A virtual surgical quide can be designed and then exported to an external system for manufacturing.

The device has no patient contact being a software only device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3Shape Implant Studio, structured as requested:

Acceptance Criteria and Device Performance Study for 3Shape Implant Studio (K202256)

Unfortunately, the provided text does not include a detailed table of acceptance criteria with reported device performance metrics. It mentions that "Each user need has its own validation acceptance criteria; each specification has its own verification acceptance criteria," and that "All test results have been reviewed and approved, showing 3Shape Implant Studio® to be substantially equivalent in safety and effectiveness to the primary predicate device." However, specific numerical targets or the device's performance against those targets are not present within this document.

Therefore, the following sections will address what information is available and highlight what is missing.

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria Category	Specific Criteria (as inferred)	Reported Device Performance (as inferred/stated)
Verification Testing	Each specification has its own verification acceptance criteria.	"All test results have been reviewed and approved, showing 3Shape Implant Studio® to be substantially equivalent in safety and effectiveness to the primary predicate device." Implied that all verification criteria were met.
Validation Testing	Each user need has its own validation acceptance criteria. Validation suite includes validation of implemented mitigations related to device hazards.	"All test results have been reviewed and approved, showing 3Shape Implant Studio® to be substantially equivalent in safety and effectiveness to the primary predicate device." Implied that all validation criteria were met and that identified risks were appropriately mitigated. Issues encountered during summative evaluation were reviewed and handled.
Bug Verification	Ensuring issue is not reproducible.	Implied that all identified bugs were successfully verified as not reproducible after fixes.
Substantial Equivalence	Comparison to predicate device (Straumann AG coDiagnostix, K130724) in terms of intended use, indications for use, scientific concept, features, technical data, and test results related to safety and effectiveness.	"3Shape Implant Studio® is found to be as safe and effective as the primary predicate device. Therefore, 3Shape Implant Studio® is found to be substantially equivalent with the primary predicate device." This suggests the device successfully met the criteria for substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not specify the sample size used for either verification or validation testing.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions that the software "reads imaging information output from medical scanners such as CT and optical scanners" and visualizes "an imported CT image from DICOM data."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not provide any information regarding an adjudication method for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study.
The device is described as an "implant planning and surgery planning software tool" intended for use by "dental professionals." It is a tool for pre-operative simulation and planning, rather than an AI-driven diagnostic or interpretative tool that would typically involve human-in-the-loop performance studies as described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance testing appears to be a standalone (algorithm only) assessment. The document states, "Software, hardware, and integration verification and validation testing was performed." The focus is on the software's functionality in terms of processing imaging data, enabling planning, and designing surgical guides, not on how human users perform with or without the software. The "summative evaluation" mentioned could potentially involve human interaction to assess usability but the performance itself is described as the software's inherent capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used. Given the nature of an implant planning software, the "ground truth" would likely relate to the accuracy of 3D reconstructions, measurements, planning parameters, and the fit/design of surgical guides. This would typically be established by expert dental professionals using established anatomical references, CAD/CAM standards, and potentially phantom models. However, this is inferred, not stated.

8. The sample size for the training set

The document does not mention a training set. This is because the 3Shape Implant Studio is described as software that allows pre-operative simulation and evaluation based on imported scan data, and is used for designing surgical guides. It is not presented as a machine learning or AI algorithm that implicitly learns from a dataset (i.e., it doesn't appear to be a 'learning' algorithm in the sense that it requires a training set for model development). It is a CAD design and visualization tool.

9. How the ground truth for the training set was established

As the document does not mention a training set (see point 8), there is no information on how its ground truth would have been established.

Summary

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September 9, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

3Shape Medical A/S % Mr. Rafael Aguila Official Correspondent Accelerated Device Approval Services, LLC 6800 S.W. 40th Street. Ste. 403 LUDLUM FL 33155

Re: K202256

Trade/Device Name: 3Shape Implant Studio Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 7, 2020 Received: August 10, 2020

Dear Mr. Aguila:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 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

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K202256

Device Name

3Shape Implant Studio

Indications for Use (Describe)

Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.

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 K202256

Submitter Information

Company Name:	3Shape Medical A/S
Company Address:	Holmens Kanal 7DK-1060 Copenhagen K
Company Phone:Company Fax:	+45 7027 2620+45 7027 2621
Contact Person:	Jenny AxelRegulatory Affairs Specialist
Date Summary Prepared:	September 4, 2020

Device Identification

510(k) number:	K202256
Trade/proprietary Name:	3Shape Implant Studio
Regulation Number:	892.2050
Classification:	Class 2
Product Code:	LLZ

Primary Predicate Device

The 3Shape Implant Studio® for implant planning and surgical guides (K202256), based on the information and supporting documentation provided, has the same indications for use, scientific concept and technical characteristics as the predicate device Straumann AG coDiagnostix

(K130724) and the reference device 3Shape Implant Studio™ 2015-1 (K152078) also manufactured by 3Shape Medical A/S.

Both, subject and predicate devices, are computer aided design software used by dental professionals trained in implantology for implant planning and the design of surqical quides after import of scan imaging data. The designed 3D models and surqical reports are exported from both devices. Therefore, the 3Shape Implant Studio® software (K202256) and the predicate device (K130724) are found to be similar in their indications for use, supported anatomic areas and the available relevant features and functionalities.

Indications for Use

3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement.

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Image /page/4/Picture/1 description: The image contains the logo for 3Shape. The logo consists of the word "3shape" in a dark blue sans-serif font, followed by a red triangular symbol. The triangular symbol is composed of three smaller triangles arranged to form a larger triangle.

Surqical quides and the planned implant position can be exported as 3D models and the quides can be manufactured using said 3D models when used as input to 3D manufacturing systems.

Device Description

The device has no patient contact being a software only device.

Scientific Concept

The underlying scientific concept is the visualization of an imported CT image from DICOM data to pre-operatively analyze and plan the placement of dental implant(s) in the maxilla and/or mandible region by taking the prosthetic and clinical requirements into consideration. Optionally, the CT image scan data can be aligned to optical 3D surface scan data or to a segmented CT scan of a denture. The implant and sleeve library files are available to the practitioner via encrypted library files, which are reviewed and approved by the original manufactures of the components. Moreover, the use of CAD design technology allows the design of a surgical quide, which can be exported to a 3rd party manufacturing device. The quide can be used for aiding the placement of the implant(s) to the intended position(s). PDF reports are generated to document the planning information and to provide an overview of the required surgical steps and components.

Summary of the technological characteristics

3Shape Implant Studio® is a software only device programmed in C# and has the following PC/laptop hardware requirements equivalent to the reference device:

Item	MinimumRequirements3Shape ImplantStudio®(K202256)	MinimumRequirementsStraumann AGcoDiagnostix(K130724)	MinimumRequirementsImplant Studio™2015-1(K152078)
OS:	Windows 7, 8 or 10 64-bit	Windows 7, Sp or Vista	Windows 7 or 8 64-bit
RAM:	16 GB	2 GB	16 GB or better
MonitorResolution:	1920x1080	1024x768 pixels	1920x1200 pixels or higher
Video CardMemory:	2GB NVIDIA (GeForceor Quadro), DirectX10/11. Maxwell ornewer architecturerecommended	-	2GB GeForce or better

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AvailableHDDSpace:	500 GB	1 GB free, plus 50 MBper plan	500 GB
CPU:	Intel Core i7 orequivalent	Intel Core or AMD Athlon64 X2	Intel Core i7 or higher
Network:	Network Internetconnection	-	Network Internetconnection
Mouse:	With the wheel button	-	Mouse with wheel buttonsupport

3Shape Implant Studio® has the same indications for use and technical characteristics as the predicate device, Straumann AG coDiagnostix (K130724).

The following table compares all newly added features and functionalities between the subject, predicate and reference devices:

Feature name	3ShapeImplantStudio®	StraumannAGcoDiagnostix	ImplantStudio™2015-1
510(k) Number	K202256	K130724	K152078
Segmentation of DentureCT scan	Yes	Yes	Yes
Alignment of CT scan datavia radiopaque markers	Yes	Yes	Yes
Option to manually aligntwo scan data set	Yes	Yes	Yes
Support for anchor pins	Yes	Yes	Yes
Gingiva supported surgicalguide design possible	Yes	Yes	Yes
Bone supported surgicalguide design possible	Yes	Yes	No

Picture archiving and communications system, 21 CFR 892.2050

The added feature for design of bone supported surgical guides with identified and implemented risk mitigations in 3Shape Implant Studio® (K202256) is identical in indications for use and the available features and functionalities compared to the predicate device.

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Nonclinical 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 on May 11, 2005).

The development of the subject software also utilized the following FDA guidances:

Technical Considerations for Additive Manufactured Medical Devices; .
· Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Prior to release, verification and validation testing of the 3Shape Implant Studio® has been completed using approved acceptance criteria: Each user need has its own validation acceptance criteria; each specification has its own verification acceptance criteria; bug verification consists in ensuring issue is not reproducible; issues encountered by users during the summative evaluation have been reviewed and handled appropriately.

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 3Shape Implant Studio® to be substantially equivalent in safety and effectiveness to the primary predicate device.

The 3Shape Implant Studio® complies with the following standards:

· IEC 62304
ISO 13485
· ISO 14971
· IEC 62366
· IEC 80001-2-2
· NEMA PS 3.1 3.20

Clinical Testing

Clinical testing is not a requirement and has not been performed.

Conclusion

Based on a comparison of intended use, indications for use, scientific concept, features, technical data, and test results, the 3Shape Implant Studio® is found to be as safe and effective as the primary predicate device. Therefore, 3Shape Implant Studio® is found to be substantially equivalent with the primary predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).