The 3Shape Abutment Designer Software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. The 3Shape Abutment Designer is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, or hybrid dental implant abutment. The single or multi-unit abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

Device Description

The 3Shape Abutment Designer™ Software receives scan data containing topographical characteristics of real teeth, dental impressions, or stone models. The software provides the user with the ability to create matching endosseous dental implant abutments using computer aided design. The output of the device is a computer file containing the abutment(s) in digital form which can be used by manufacturers that hold an implant abutment 510(k) or are milling per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment. The 3Shape Abutment Designer Software output is restricted in the U.S. to be manufactured by a holder of an implant abutment 510(k) or milled per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment. The 3Shape Abutment Designer™ Software can be run on properly configured "off-the-shelf" PC hardware running Microsoft® Windows and using a standard keyboard and mouse. The 3Shape Abutment Designer™ Software requires the loading of implant libraries, which includes information such as implant type, maximum and minimum dimensional parameters for abutments, etc., created by separate abutment manufacturers and cleared by the FDA. In the US, the Implant Libraries are obtained via a 3Shape server after demonstration to 3Shape of the FDA clearance of the Implant Library.

AI/ML Overview

The provided text describes the 3Shape Abutment Designer™ Software, its intended use, and the nonclinical testing performed for its 510(k) submission. However, it does not provide specific details on acceptance criteria or a detailed study proving the device meets those criteria, as typically found in a clinical study report.

The text focuses on the software's substantial equivalence to a predicate device (Sirona Dental CAD/CAM System) by comparing their intended use, technological characteristics, and software output. The "Nonclinical Testing" section broadly mentions "approved acceptance criteria" but without enumerating them or describing a specific study report that would contain the requested details.

Therefore, many of the requested elements cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or extracted, and what is missing:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (General)	Reported Device Performance (General)
Each user need has its own validation acceptance criteria.	Validation testing of the 3Shape Abutment Designer™ Software has been completed.
Each specification has its own verification acceptance criteria.	Verification testing of the 3Shape Abutment Designer™ Software has been completed.
Bug verification consists in ensuring issue is not reproducible.	Bug verification was performed; issues reported by beta partners were reviewed and handled appropriately.
Beta partners must report functionality to be an improvement over previous version.	Beta partners' feedback was considered in ensuring functionality improvement.
Validation of implemented mitigations related to device hazards identified in the risk management procedures.	Validation suite includes validation of implemented mitigations.

Missing: Specific, quantifiable acceptance criteria (e.g., accuracy metrics, specific error rates, precision targets) are not detailed. The actual performance outcome against numerical targets for these acceptance criteria is also not provided.

2. Sample size used for the test set and the data provenance

Missing: The text does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). "Test set" in this context refers to the data used for the "verification and validation testing" mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing: This information is not provided. The testing described is primarily software verification and validation, not a clinical study involving expert ground truth establishment for diagnostic or treatment efficacy.

4. Adjudication method for the test set

Missing: This information is not provided.

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

Missing: No MRMC comparative effectiveness study is mentioned. The device is software for designing abutments, not an AI for diagnosis or interpretation that would typically involve human readers.

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

The device is a standalone software component ("algorithm only" in the sense that it automates design based on input). The "Device Description" states it receives scan data and provides digital output. The "Nonclinical Testing" section confirms "Software, hardware, and integration verification and validation testing was performed." This implies standalone testing of the software's functionality.

However, specific performance metrics for this standalone functionality are not detailed.

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

Missing: The text does not explicitly state the type of "ground truth" used for its verification and validation. Given the nature of the software (CAD for dental abutments), the "ground truth" likely refers to established engineering specifications, design rules, and possibly simulated or physical models that conform to dental anatomical and functional requirements. It is not clinical "ground truth" in the diagnostic sense (like pathology or outcomes data).

8. The sample size for the training set

Missing: This is not applicable in the typical sense of a machine learning "training set." The 3Shape Abutment Designer™ Software appears to be a rule-based CAD software, not a machine learning algorithm that is "trained" on a dataset. It "requires the loading of implant libraries" which contain design information cleared by the FDA, but these are not "training sets."

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

Missing: As per point 8, a "training set" in the machine learning context is not applicable here. The "implant libraries" used by the software are based on information from actual implant manufacturers, cleared by the FDA, which function as pre-defined specifications and constraints rather than a statistical training dataset.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 6, 2016

3Shape A/S Hanne Nielsen Regulatory Affairs Manager Holmens Kanal 7 Copenhagen, 1060 DENMARK

Re: K151455

Trade/Device Name: 3Shape Abutment Designer™ Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP Dated: January 8, 2016 Received: January 11, 2016

Dear Hanne Nielsen:

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. 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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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151455

Device Name

3Shape Abutment Designer™ 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 - Traditional 510(K)

Submitter Information

	A Company Name:	3Shape A/S
	B Company Address:	Holmens Kanal 7DK-1060 Copenhagen K
	C Company Phone:Company Fax:	+45 7027 2620+45 7027 2621
	D Contact Person:	Hanne NielsenRegulatory Affairs Manager
	E Date Summary Prepared:	June 28, 2016
Device Identification
	A Trade/proprietary Name:	3Shape Abutment Designer™Software
	B Common Name:	Abutment design software for dentallaboratory
	C Device Classification Name:	Endosseous Dental Implant Abutment
	C Requlation Number:	872.3630
	C Classification:	Class II
	D Product Code:	PNP

Predicate Device

Sirona Dental CAD/CAM System (K100152).

Intended Use

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implant abutment. The single or multi-unit abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

Device Description

The output of the device is a computer file containing the abutment(s) in digital form which can be used by manufacturers that hold an implant abutment 510(k) or are milling per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment. The 3Shape Abutment Designer Software output is restricted in the U.S. to be manufactured by a holder of an implant abutment 510(k) or milled per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment.

The 3Shape Abutment Designer™ Software can be run on properly configured "off-the-shelf" PC hardware running Microsoft® Windows and using a standard keyboard and mouse.

The 3Shape Abutment Designer™ Software requires the loading of implant libraries, which includes information such as implant type, maximum and minimum dimensional parameters for abutments, etc., created by separate abutment manufacturers and cleared by the FDA. In the US, the Implant Libraries are obtained via a 3Shape server after demonstration to 3Shape of the FDA clearance of the Implant Library.

Summary of the technological characteristics

The 3Shape Abutment Designer™ is a software only device programmed in the Delphi programming language and has the following PC/laptop requirements and other technological characteristics as compared to the predicate device:

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Item	SubmissionDevice MinimumRequirements	SubmissionDeviceRecommended	Predicate Device
OS	Windows 7 32-bitProfessional*	Windows 7 64-bitProfessional	Windows Vista 32- bit
RAM	4GB	8GB (16GB)	6GB
Video Card	512MB DirectX10 (1GB DirectX10)	1GB DirectX 11(2GB DirectX11)	512 MB DirectX 10NVIDIA Quadro
AvailableHDD Space	250GB	500GB (1TB)	500GB
CPU	Intel Core i5or equivalent	Intel Core i7or equivalent	Intel Core i7
Monitorresolution	1440 x 900 pixels	1920 x 1080pixels	Unknown
3D Mouse	None	3DConnexionSpaceMouse™	Unknown
Network	Internet connection		Unknown
Ports	USB 2.0 port for 3Shapedesktop scanner		Serial Port PCI card for inEOSscanner
Mouse	Mouse with wheel button support		Unknown

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Indicationsfor Use	The 3Shape Abutment Designer Software isintended as an aid in the restoration ofchewing function in partially or fullyedentulous mandibles and maxillae. The3Shape Abutment Designer Software isintended for use by a dental practitioner ordental laboratory staff for designing thepatient specific component of a two-piece,one-piece or hybrid dental implantabutment. The single or multi-unitabutment design is intended to be used bythe manufacturer of an endosseous dentalimplant abutment to create the final device.	The Sirona Dental CAD/CAM Systemis intended for use in partially or fullyedentulous mandibles and maxillae insupport of single or multi-unti cementretained restorations. The systemconsists of three major parts:TiBase, InCoris mesostructure, andCAD/CAM software. Specifically, theInCoris mesostructure and TiBasecomponents make up a two-pieceabutment which is used inconjunction with endosseous dentalimplants to restore the function andasesthetics in the oral cavity. TheInCoris mesostructure may also beused in conjunction with the CAMlogTitanium base CAD/CAM (typesK2244.xxxx) (K083496) in theCamlog Implant System. TheCAD/CAM software is intended todesign and fabricate the InCorismesostructure. The InCorismesostructure and TiBase two-pieceabutment is compatible with thefollowing implant systems: NobelBiocare Replace (K020646), NobelBiocare Branemark (K022562),Friadent Xive (K013867), Biomet 3iOsseotite (K980549), Astra TechOsseospeed (K091239), ZimmerTapered Screw-Vent (K061410), andStraumann SynOcta (K061176).
SoftwareOutput	Digital encrypted or non-encryptedproprietary or .STL file including only thepatient-specific abutment component forone-piece, two-piece, or hybrid abutmentdesigns. The digital output does not includethe abutment-to-implant connectioninterface.	.STL file of the ceramic mesostrucutresent to Sirona Dental CAD/CAMSystem milling unit
Physical -Output	N/A – Submission device relies on separateregulatory clearance and manufacture of theabutment by a separate company	Two-piece Tibase abutment - pre-milled titanium base combined withceramic mesostructure designed inSirona CAD/CAM software.
MillingLocation	Abutment Manufacturer or Dental laboratoryper the 510(k) clearance of the dentalabutment	Local milling of the ceramic abutmentcomponent.

The predicate Sirona device includes in the marketing clearance the twopiece TiBase Abutments (titanium bases and ceramic blocks) as a physical output as well as a validated milling unit and directions for assembly of the final dental abutment. The 3Shape Abutment Designer™ Software does not provide any physical parts that can come into contact with the patient. The 3Shape Abutment Designer Software instead provides only the digital design as an accessory to the physical dental abutment systems cleared by other manufacturers. The differences between the Indications for Use

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Statement of the submission device and the predicate are related to the lack of physical output from the submission device and reliance on previous or subsequent FDA clearance of the physical abutment by a separate manufacturer. However, the difference does not change the intended use of the device.

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) as well as the FDA Guidance Document "Off-The-Shelf Software Use in Medical Devices (Issued on September 9, 1999).

Prior to release, verification and validation testing of the 3Shape Abutment Designer™ Software has been completed using the 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 reported by beta partners must be reviewed and handled appropriately; beta partners must report functionality to be an improvement over previous version.

The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.

Conclusion

Based on a comparison of intended use, principle of operations, features and technical data, and the verification/validation test results, the 3Shape Abutment Designer™ Software is found to be substantially equivalent with the Predicate Device.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)