The AbutmentCAD module is intended as an aid to the restoration in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

Device Description

AbutmentCAD is a software application for the purpose of designing patient-specific implant-based dental restorations, such as one-piece abutments, two-piece/hybrid abutments and single or multi-unit screw retained restorations. The AbutmentCAD software can be used with basic dental CAD systems such as exocad's ChairsideCAD. AbutmentCAD is used solely for the patient-specific components of abutments and screw retained crowns and bridges. The software application runs on "off-the-shelf" PC hardware with current Microsoft Windows operating system and standard peripheral components.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for AbutmentCAD:

Note: The provided document is a 510(k) Summary, which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. It does not present a detailed clinical study with performance metrics in the way a typical AI-based diagnostic device FDA clearance would. Instead, it focuses on software verification and validation, ensuring the software performs its intended function within defined parameters and adheres to design limitations.

Acceptance Criteria and Reported Device Performance

The document primarily focuses on the software's ability to accurately enforce design limitations and correctly process data, rather than diagnostic accuracy metrics.

Acceptance Criteria (Related to Performance)	Reported Device Performance
Design Limitations Enforcement Accuracy:
Dimensional constraints (e.g., minimum/maximum height, diameter, wall thickness)	Correctly triggered with an accuracy of 0.01mm.
Angular constraints (e.g., angulation of abutment, screw channel)	Correctly triggered with an accuracy of 0.5°.
Implant Library Integrity:	Libraries are digitally signed, and any modification is detected, preventing their use. (This ensures that design parameters conform to implant manufacturer specifications and are not tampered with.)
Software Functionality and User Requirements:	"Prior to release of AbutmentCAD the verification and validation of the device has been completed. Each user requirement and each product requirement derived thereof has an own acceptance criteria." (Specific performance metrics for each requirement are not detailed in this summary, but the successful completion of verification and validation is asserted.)
Adherence to Implant Manufacturer Instructions: (Design software's ability to ensure resulting designs conform to specific instructions)	"Design limitations stored in the Implant Libraries are verified so that items with design parameters beyond the defined limitations cannot be created with the AbutmentCAD software application." "With the information of design limitations... it is possible to control the design process and ensure that the design results conform to implant specific instructions of the implant manufacturer." A software tool for creating abutment libraries was validated to ensure design parameters are enforced.
Manufacturing Compatibility: (Ability to generate designs compatible with manufacturing)	"Additional information of specific capabilities of the machine are adhered to by AbutmentCAD directly at the stage of design to ensure that the part can be manufactured."
Cybersecurity: (Software's robustness against cybersecurity threats)	A cybersecurity analysis was performed, and exocad monitors vulnerabilities post-market. Testing includes cybersecurity requirements. (No specific performance metrics are given, but compliance with guidance is stated.)

Details of the Study/Testing

Given that this is a 510(k) for a CAD software, the "study" described is primarily software verification and validation testing, not a clinical trial or large-scale comparative effectiveness study for diagnostic accuracy.

Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated as a single number of cases. The testing involved "realistic and artificial data" for verifying design limitations.
- Data Provenance: Not specified in terms of country of origin. The data includes "imported scan and the geometry information of objects in integrated implant libraries." The testing uses "realistic and artificial data." It is software validation, so likely a mix of simulated and real-world-representative data, potentially from internal sources. It's retrospective in the sense that it's testing a developed software against pre-existing data or simulated scenarios.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For verifying geometric and angular accuracy, the "ground truth" would likely be derived from engineering specifications, CAD standards, and the explicit instructions provided by the implant manufacturers (which form the basis of the "Implant Libraries"). "3rd party tools" were used to prove the correctness of the software.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. The verification tests involved checking if the software correctly enforced the predefined design limitations using precise measurements (0.01mm, 0.5° accuracy) and external tools, rather than human expert adjudication of subjective interpretations.
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, an MRMC study was not done. This device is a CAD software for design, not a diagnostic AI system intended to assist human readers in image interpretation or diagnosis. It aids in the design of dental prosthetics based on pre-established parameters.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The core verification for enforcing design limitations and maintaining library integrity is a standalone performance assessment of the algorithm's accuracy in following its programming rules. The software itself, without human intervention during the calculation/enforcement of constraints, needs to perform accurately. However, it's explicitly "intended to be used by trained professionals in dental practices or dental laboratories for the design." So, while standalone verification of programmatic rules occurred, the overall device is a human-in-the-loop tool for design.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for design limitations is based on engineering specifications and explicit instructions provided by the original implant manufacturers. These are encoded into the "Implant Libraries." The accuracy of the software in adhering to these parameters (0.01mm for dimensions, 0.5° for angles) forms the primary ground truth for the verification testing.
The sample size for the training set:
- Not applicable / Not mentioned. This device description does not indicate the use of machine learning that would typically involve a "training set." It appears to be a rule-based CAD software where design limitations are explicitly programmed rather than learned from data. The "Implant Libraries" are essentially predefined data sets of specifications, not training data in the ML sense.
How the ground truth for the training set was established:
- Not applicable. As no machine learning training set is mentioned, this question is not relevant. The "ground truth" for the software's functionality relates to correctly implementing engineering and manufacturer specifications.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.

exocad GmbH Stefan Walter Quality Manager 37 Julius-Reiber-Str. Darmstadt, HE 64293 GERMANY

Re: K193352

Trade/Device Name: AbutmentCAD Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP Dated: June 13, 2021 Received: June 21, 2021

Dear Stefan Walter:

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.

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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 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,

Andrew I. Steen 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) K193352

Device Name

AbutmentCAD

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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K193352 510(k) Summary

Submitter Information

exocad GmbH 37 Julius-Reiber-Strasse Darmstadt, HE 64293 Germany Contact Person: Stefan Walter, Quality Manager Phone: +49-6151-629489-0

Establishment Registration number: 3011521456

Date prepared: 2021-07-21

Manufacturing Facility

Same as submitter.

Device Information

Trade/proprietary Name: Device Classification Name: Regulation Number: Classification: Classification Product Code: AbutmentCAD Dental Abutment Design Software for Dental Laboratory 872.3630 Class II PNP

Predicate Device

AbutmentCAD has been compared to the following predicate legally marketed device:

510(k) Number:	K151455
Predicate device:	3Shape Abutment Designer
Manufacturer:	3Shape A/S, Holmens Kanal 7, DK-1060 Copenhagen K

Indications for Use

The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

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Device Description & Summary of Technical Characteristics

The software application runs on "off-the-shelf" PC hardware with current Microsoft Windows operating system and standard peripheral components.

Design - Abutments

A restoration is designed based on the imported scan and the geometry information of objects in integrated implant libraries based on data of original implant manufacturers. These libraries contain data of connection geometries to implants and so called "design limitations" (also referred to as "design constraints" in other devices) in order to adhere to specific instructions of implant manufacturers of 510(k) cleared implants/abutments. For more details see next section.

The respective connection geometry cannot be changed in the design process. The usage of these libraries allows to design high precision, implant-based restorations for the following design options:

Abutments, one-piece, two-piece/hybrid
. Bridges, screw retained (multi-unit crown)
Crowns, screw retained
Bars, screw retained

During the design of one of the above reconstructions, design limitations (e.g. angulation, height, etc.) stored in the Implant Libraries are verified so that items with design parameters beyond the defined limitations cannot be created with the AbutmentCAD software application. These limitations correspond to the specific instructions of the holder of an implant abutment 510(k).

The final design geometry along with information on the required material is transferred to a compatible milling system for manufacturing. Furthermore, with the information of a selected target milling machine for manufacturing of the part under design, additional information of specific capabilities of the machine are adhered to by AbutmentCAD directly at the stage of design to ensure that the part can be manufactured.

Manufacturing (not in the scope of the device under evaluation)

Restorations designed with AbutmentCAD may only be manufactured by holders of an implant abutment 510(k) or milled according to the specific instructions provided by the holder of a 510(k)-clearance for a patientspecific implant abutment.

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Implant Libraries

AbutmentCAD uses so called abutment libraries that are based on detailed information, sizes, catalogue numbers, 3D meshes and information about design limitations (see below) of implants. All information is provided by the original manufacturer of a respective physical part and is integrated by exocad into a library. Implant libraries may contain, e.g. implants, a titanium bases and similar related parts.

AbutmentCAD loads the library parts during the design process. The connection geometry defined by the implant manufacturer cannot be modified at any time. The implant libraries allow to define so called design limitations such as maximum height or maximum anqulation for the design of an abutment.

With the information of design limitations of the parts (e.g. the angulation or maximum height) contained in the implant libraries it is possible to control the design process and ensure that the design results conform to implant specific instructions of the implant manufacturer.

The libraries are digitally signed and by that any modification of a library content or the referred library parts or files is detected by AbutmentCAD and it is not possible to use the library.

Information contained in a library is:

Data of interface parts, such as titanium bases, compatible to a specific implant, and interface . geometry to the tooth reconstruction
Data not used for the design, which serves merely for graphical representation during the design ● process (e.g. screw threads, implant analogs, pre-mill holders, and other meta information)
. Data defining the minimum thickness geometry as a lower limit to the design of implant-based restorations.
Scan abutment data that allows recognition of the implant position within optical scan data
Data of design limitations, as required by holder of an implant abutment 510(k), for implant-based tooth reconstructions, such as maximum and minimum dimensional parameters.
Connection geometry and screw channel geometry, permitting a design of reconstruction with an interface, e.g. titanium base and direct-to-implant tooth reconstruction (e.g. single piece abutments/screw-retained crowns and bridges).

Design Limitations

The following design limitations are adhered to for the design of abutments:

minimum wall thickness .
. minimum and maximum height of the emergence profile
minimum and maximum diameter of the emergence profile ●
minimum and maximum height of the entire abutment ●
minimum and maximum height of the abutment above the emergence profile ●
minimum and maximum anqulation of the abutment above the emergence profile in relation to the ● implant axis
minimum and maximum angulation of the screw channel in relation to the axis of the abutment above the emergence profile
minimum and maximum angulation of the screw channel in relation to the implant axis ●
size limitation of the abutment due to the size of the pre-milled abutment blank ●
restriction to specific tooth numbers (e.g. narrow implants are typically intended to be used for ● anterior teeth)

The following design limitations are adhered to for the design of screw retained bridges:

overall length of a bridge
. length of a bridge arc between two implants
length of a bridge extension .
length of a single unit implant-based bridge with bridge extension ●
size requirements for the manufacturing of the bridge (size of the intended blank or stock material versus size of the bridge under design)

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Non-clinical Testing

Software verification and validation is performed in accordance with the applicable guidance document, ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005). Prior to release of AbutmentCAD the verification and validation of the device has been completed. Each user requirement and each product requirement derived thereof has an own acceptance criteria.

A cybersecurity analysis was performed in accordance with the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued on 2014-10-02. exocad monitors vulnerabilities of the products and components during lifetime and analyses them in a post-marketcybersecurity process that involves also risk management.

Detected anomalies are evaluated and either resolved or in case of a minor issue described in the release notes. The testing includes a validation with end-users of the product. Feedback of software testers and feedback from validation is regarded in the device as appropriate.

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

During software verification we ensure that the design limitations are correctly triggered with an accuracy of 0.01mm for dimensional constraints and an accuracy of 0.5° for angular constraints. For verification realistic and artificial data and a 3ª party tools are used to proof the correctness of our software with respect of the design limitations.

In order to generate an abutment design library, exocad developed a software tool which is part of, and used in conjunction with AbutmentCAD. It is made available to the holder of an abutment 510(k) to support the creation abutment libraries which include specific design parameters of abutments. Use of this tool is mandatory for creating abutment libraries and ensures abutment design parameters are enforced through the design process. The software tool and its output have been validated as part of this premarket notification.

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Comparative information on Predicate Device

Abutment CAD has been compared to the following predicate legally marketed device: 510(k) Number: K151455 3Shape Abutment Designer Predicate device:

The following tables provides a comparison of the predicate device with AbutmentCAD.

ComparableCriteria	Predicate device	Device under evaluation	Evalu-ation
Trade/ proprietaryName, 510(k) #:	3Shape Abutment Designer, K151455	AbutmentCAD 2.3	---
DeviceClassification:	Dental Abutment Design Software For DentalLaboratory	Dental Abutment Design Software For DentalLaboratory	Substantiallyequivalent
Regulation Number:	872.3630		Substantiallyequivalent
Classification:	Class II	Class II	Substantiallyequivalent
Product Code:	PNP	PNP	Substantiallyequivalent
Prescription/ overthe counter use	Prescription use	Prescription use	Substantiallyequivalent
Indications for Use	The 3Shape Abutment Designer Software is intendedas an aid to the restoration of chewing function inpartially or fully edentulous mandibles and maxillae.The 3Shape Abutment Designer Software is intendedfor use by a dental practitioner or dental laboratorystaff for designing the patient specific component of atwo-piece, one-piece or hybrid dental implantabutment. The single or multi-unit abutment design isintended to be used by the manufacturer of anendosseous dental implant abutment to create the finaldevice.	The AbutmentCAD module is intended as an aidto the restoration of chewing function in partiallyor fully edentulous mandibles and maxillae.AbutmentCAD is a software device intended tobe used by trained professionals in dentalpractices or dental laboratories for the design ofpatient specific implant borne prosthetics suchas one-piece abutments, two-piece/hybridabutments, single or multi-unit screw-retainedrestorations. The design result is intended to beused by the manufacturer of an endosseousdental implant abutment to create the finaldevice.	Substantiallyequivalent
- used as	The 3Shape Abutment Designer Software is intendedas an aid to the restoration of chewing function inpartially or fully edentulous mandibles and maxillae.	The AbutmentCAD module is intended as an aidto the restoration of chewing function in partiallyor fully edentulous mandibles and maxillae.	Substantiallyequivalent
- used by	"… intended for use by a dental practitioner or dentallaboratory staff …"	"… intended to be used by trained professionalsin dental practices or dental laboratories …"	Substantiallyequivalent
- used for	"… for designing the patient specific component of atwo-piece, one-piece or hybrid dental implantabutment …"	"… for the design of patient specific implantborne prosthetics such as one-piece abutments,two-piece/hybrid abutments, single or multi-unitscrew-retained restorations …"	Substantiallyequivalent
- result used by	"… design is intended to be used by the manufacturerof an endosseous dental implant abutment to createthe final device."	"… design result is intended to be used by themanufacturer of an endosseous dental implantabutment to create the final device."	Substantiallyequivalent
Input data	scan data containing topographical characteristics ofreal teeth, dental impressions, or stone models	scan data containing topographicalcharacteristics of real teeth, dental impressions,or stone models	Substantiallyequivalent
Design options	endosseous dental implant abutments; as per specificinstructions of the implant manufacturer	endosseous dental implant abutments; specificinstructions of the implant manufacturer areadhered to during the design process	Substantiallyequivalent
Libraries	FDA clearance of the Implant Library.	FDA clearance of the Implant Library, validationby abutment 510(k) holder, cannot be modifiedby end-user.	Substantiallyequivalent
Output data	Digital encrypted or non-encrypted proprietary or .STLfile including only the patient-specific abutmentcomponent for one-piece, two-piece, or hybridabutment designs.	Digital encrypted or non-encrypted proprietary or.STL file including only the patient-specificabutment component for one-piece, two-piece,or hybrid abutment designs. Encryption status ofthe library will be determined solely by the 510(k)	Substantiallyequivalent

		clearance of the abutment system.
Physical output	N/A - Submission device relies on separate regulatoryclearance and manufacture of the abutment by aseparate company	N/A - Submission device relies on separateregulatory clearance and manufacture of theabutment by a separate company	Substantiallyequivalent
Milling location	Abutment Manufacturer or Dental laboratory per the510(k) clearance of the dental abutment	Abutment Manufacturer or Dental laboratory perthe 510(k) clearance of the dental abutment	Substantiallyequivalent
Hardware	Compatible of-the-shelf PC	Any compatible of-the shelf PC, Monitor andnetwork connection	Substantiallyequivalent
GUI OS	Windows 7 32-bit or 64-bit Professional	Windows ® 7, 8.1, 10; 64-bit Operating System	Substantiallyequivalent,Up-to-dateOS used

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AbutmentCAD has been compared to a legally marketed predicate device (3Shape Abutment Designer Software, K151455) as documented above. The conclusion is that, based on the comparison of intended use and various characteristics, AbutmentCAD is substantially equivalent to 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.)