exoplan is a medical software, intended to support the planing of dental implants using the visualization of the implant placement within images of the patient's anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient's anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.

exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.

The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.

Device Description

exoplan is a standalone software application for the purpose of pre-operative implant planning and design of surgical guides to support the surgical intervention.

The software application runs on "off-the-shelf" PC hardware with Microsoft Windows 10 operating system (64 Bit), off-the shell GPU card and otherwise standard peripheral components.

The device allows importing 3D CT and optical scans from teeth, dental impression, or stone models) from compatible intraoral or desktop scanners. While the planning of implant position is mainly based on the information of the CT data, the design of a surgical quide is based on the STL data of the optical scan. Both modalities are registered to a common coordinate system to ensure that the implant positions defined by a user can be used for design of a surgical guide.

exoplan uses so called component libraries, which contain (e.g., physical dimensions, compatibility, etc.) provided by the original manufacturer of a component, and cover all components that can be used during treatment and necessary to consider during planning, e.g. implants, drills and drill sleeves. The libraries are digitally signed. This ensures that any modification of the content of a library will be detected by exoplan. The issue is then reported to the user and documented in the Implant Planning Report or the Surgical Protocol.

exoplan has no contact with the patient.

AI/ML Overview

The provided text primarily focuses on the FDA 510(k) Summary for the "exoplan" device, describing its indications for use, device description, and a comparison to predicate and reference devices. It does mention "Non-Clinical Performance Testing" and that "Furthermore, accuracy tests were performed to verify that the planning results are as accurate as defined." However, it does NOT provide specific details about the acceptance criteria or the study that definitively proves the device meets those criteria, outside of a general statement about software verification, validation, and accuracy tests. It explicitly states, "Clinical testing is not a requirement and has not been performed."

Therefore, based on the provided text, I cannot fully answer all aspects of your request. I can only provide the information that is explicitly stated or strongly implied.

Here's an attempt to answer your questions based on the limited information available:

Acceptance Criteria and Device Performance Study for exoplan (K213302)

Based on the provided 510(k) Summary, specific quantitative acceptance criteria and detailed performance study results are not explicitly disclosed. The document generally refers to "Software verification and validation" and "accuracy tests."

1. A table of acceptance criteria and the reported device performance

The document states:

"Each user requirement and each derived product requirement has an own acceptance criteria."
"Furthermore, accuracy tests were performed to verify that the planning results are as accurate as defined."

However, no specific quantitative acceptance criteria or corresponding reported device performance values are provided in this document. The document only generally states that "the verification of the device has been completed" and that "the results of verification and validation ensure that the new device is as safe and as effective."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any "test set" or "accuracy tests." It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not specify the number of experts or their qualifications used to establish ground truth for any test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not mention any adjudication method for a 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 explicitly states: "Clinical testing is not a requirement and has not been performed." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size regarding human reader improvement with AI assistance is available.

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

The document describes "accuracy tests" and "software verification and validation," implying a standalone evaluation of the algorithm's performance against predefined criteria. However, no specific data or metrics from such standalone performance are provided. The device (exoplan) is described as a "medical software, intended to support the planing of dental implants," indicating a human-in-the-loop use case.

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

The document refers to "accuracy tests... to verify that the planning results are as accurate as defined." Given the nature of the device (dental implant planning software), the ground truth for these "accuracy tests" would most likely involve measurements against known physical or digital standards, or potentially comparisons to expert-derived ideal plans. However, the exact type of ground truth (e.g., physical phantoms, simulated anatomical models, or expert consensus on ideal implant placement) is not explicitly stated. Pathology or outcomes data would not typically be applicable to pre-operative planning software validation as it's not a diagnostic or outcome-predicting tool.

8. The sample size for the training set

The document does not mention a training set size. This is likely because the device, as described, is a software tool for planning and design, rather than an AI/ML model that would typically require a distinct training set (though verification and validation apply to all software).

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

Since no training set is mentioned as applicable to this type of software according to the document, the establishment of its ground truth is not applicable/not described.

Summary

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May 3, 2022

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below that.

exocad GmbH % Tobias Turba Quality Engineer 37. Julius-Reiber-Str. Darmstadt, Hesse 64293 GERMANY

Re: K213302

Trade/Device Name: exoplan Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 29, 2022 Received: March 31, 2022

Dear Tobias Turba:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809; 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 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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K213302

Device Name exoplan

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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510(k) Summary, Traditional 510(k)

Submitter Information

exocad GmbH 37, Julius-Reiber-Straße Darmstadt, HE 64293 Germany

Contact Person: Tobias Turba, Quality Engineer Phone: +49-6151-629489-0 fax: +49 6151-629489-9

Establishment Registration number: 3011521456

Date prepared: 2021-09-29

Manufacturing Facility

Same as submitter.

Device Information

Trade/proprietary Name:	exoplan
Common Name/Usual name:	Dental Implant Planning and tooth/gingiva supportedSurgical Guide design software
Device Classification Name:	Medical image management and processing system
Regulation Number:	892.2050
Classification:	Class II
Classification Product Code:	LLZ

Predicate Device

exoplan has been compared to the following predicate legally marketed device: 510(k) Number: K183458 Device name: exoplan 2.3 Manufacturer: exocad GmbH, Julius-Reiber-Str. 37, 64293 Darmstadt

Reference Device

exoplan has been compared to the following reference legally marketed device:

510(k) Number:	K202256
Device name:	Implant StudioTM
Manufacturer:	3Shape A/S, Holmens Kanal 7, DK-1060 Copenhagen

Indications for Use

exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient's anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient's anatomy as well as a virtual prosthetic proposal.

exoplan allows the design of surgical quides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions.

Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the

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surgical guide to support the manufacture of a separate physical product.

exoplan does not extend or change indications of dental implants. Usage of a surgical quide designed with the software does not change the necessary due diligence required to conventional (non-quided) surgery.

Device Description & Summary of Technical Characteristics

exoplan is a standalone software application for the purpose of pre-operative implant planning and design of surgical guides to support the surgical intervention.

The software application runs on "off-the-shelf" PC hardware with Microsoft Windows 10 operating system (64 Bit), off-the shell GPU card and otherwise standard peripheral components.

exoplan has no contact with the patient.

Non-Clinical Performance 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 exoplan the verification of the device has been completed. Each user requirement and each derived product requirement has an own acceptance criteria. Detected anomalies are evaluated, resolved or where appropriate (e.g. in case of a minor issue) described in the release notes. The verification and validation include the verification and where appropriate validation of the risk mitigation measure as defined by the risk analysis. Feedback of software testers and feedback from validation is regarded in the device as appropriate. Furthermore, accuracy tests were performed to verify that the planning results are as accurate as defined.

Clinical

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

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Comparative information on Predicate Device

exoplan has been compared to the following legally marketed devices:

Predicate Device: exoplan 2.3 (K183458) Reference Device: Implant Studio (K202256)

ComparableCriteria	Device under evaluation	Predicate device	Reference device	Eval.
Trade/proprietaryName, 510(k) #:	exoplan	exoplan (K183458)	K202256, Implant Studio™	---
Reason forcomparison	---	Primary software features andfunctionality.Predecessor of the exoplanversion that is subject to thissubmission.	Features that are not availablein the predicate device:- Edentulous case planning- Virtual tooth extraction	---
DeviceClassificationName:	Medical imagemanagement andprocessing system	Medical imagemanagement andprocessing system	Medical imagemanagement andprocessing system	same
RegulationNumber:	892.2050	892.2050	892.2050	same
Classification:	Class II	Class II	Class II	same
Product Code:	LLZ	LLZ	LLZ	same
Prescription/over the counteruse	Prescription use	Prescription use	Prescription use	same
indications foruse	exoplan is a medical software,intended to support the pre-operative planning of dentalimplants using the visualization ofthe implant placement withinimages of the patient's anatomy.The process is based onCT/CBCT data sets originatingfrom other medical devices, andcan be supported by opticalscan(s) of the patient's anatomyas well as a virtual prostheticproposal.exoplan allows the design ofsurgical guides to support theplacement of endosseous dentalimplants in guided surgery. Thedesign of surgical guides isbased on 3D surface datarepresenting the preoperativesituation and approved implantpositions.Alternatively, instead of opticalsurface data a second CBCT/CTdataset can be used.The software exports theplanning and design results asgeometrical data and a digital 3Dmodel of the surgical guide tosupport the manufacture of aseparate physical product.exoplan does not extend orchange indications of dentalimplants. Usage of a surgicalguide designed with the softwaredoes not change the necessarydue diligence required comparedto conventional (non-guided)surgery.The software is intended to beused only by dental professionals	exoplan is a medical software,intended to support the pre-operative planning of dentalimplants using the visualization ofthe implant placement withinimages of the patient's anatomy.The process is based onCT/CBCT data sets originatingfrom other medical devices, andcan be supported by opticalscan(s) of the patient's anatomyas well as a virtual prostheticproposal.exoplan allows the design ofsurgical guides to support theplacement of endosseous dentalimplants in guided surgery. Thedesign of surgical guides isbased on 3D surface datarepresenting the preoperativesituation and approved implantpositions.The software exports theplanning and design results asgeometrical data and a digital 3Dmodel of the surgical guide tosupport the manufacture of aseparate physical product.exoplan does not extend orchange indications of dentalimplants. Usage of a surgicalguide designed with the softwaredoes not change the necessarydue diligence required comparedto conventional (non-guided)surgery.The software is intended to beused only by dental professionals	3Shape Implant Studio is animplant planning and surgeryplanning software tool intendedfor use by dental professionalswho have appropriateknowledge in dentalimplantology and surgicaldentistry. This software readsimaging information output frommedical scanners such as CTand optical scanners. It allowspre-operative simulation andevaluation of patient anatomyand dental implant placement.Surgical guides and theplanned implant position can beexported as 3D models and theguides can be manufacturedusing said 3D models whenused as input to 3Dmanufacturing systems.	Highly Similarto thepredicateSimilar to thereference
	with sufficient medical training indental implantology and surgicaldentistry in office environmentssuitable for reading diagnosticdental DICOM data sets. exoplanshall not be used for any purposeother than planning dentalimplant placement or design ofsurgical guides.	with sufficient medical training indental implantology and surgicaldentistry in office environmentssuitable for reading diagnosticdental DICOM data sets. exoplanshall not be used for any purposeother than planning dentalimplant placement or design ofsurgical guides.
Users	dental professionals withsufficient medical training indental implantology and surgicaldentistry	dental professionals withsufficient medical training indental implantology and surgicaldentistry	dental professionals who haveappropriate knowledge indental implantology andsurgical dentistry	Same aspredicateHighly similarto reference
Input data	CT image data andoptical surface scan	CT image data andoptical surface scan	CT image data andoptical surface scan	same
Registration /Alignment of CRimage data andoptical surfacescan	Yes	Yes	Yes	same
Output data	Implant planning report, surgicalprotocol, STL file with designedguide for manufacturing	Implant planning report, surgicalprotocol, STL file with designedguide for manufacturing	surgical report, drill protocol isprovided, STL file withdesigned guide formanufacturing	same
Avoidance ofRisk Areas(anatomicalmarkers)	Mandibular nerve canal andsinus cavity	Mandibular nerve	Mandibular nerve	sametechnology,additionallocations,validatedthroughperformancetesting.
Ability to createguides foredentulouspatients	Yes	No	Yes	same asreference
Virtual ToothExtractor	Yes	No	Yes	Same asreference
Surgical guidemanufacturing	Transfer to a manufacturing site.	Transfer to a manufacturing site.	Transfer to a manufacturingsite.	same
Hardware	Any compatible off-the-shelf PCwith a dedicated GPU, monitorand network connection	Any compatible off-the-shelf PCwith a dedicated GPU, monitorand network connection	Any compatible of-the shelf PC,GPU, monitor and networkconnection	same
GUI OS	Windows ® 10; 64-bit OperatingSystem	Windows ® 7, 8.1, 10 ; 64-bitOperating System	Windows ® 7, 8.1, 10 ; 32 and64-bit Operating System	Highly similar-removed older,not supportedOS for security

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Overall, the subject and predicate as well as reference devices are the same or highly similar, with any differences mitigated through non-clinical performance testing and software validation, supporting a finding of substantial equivalence. New features are similar to those included in the reference device and the results of verification and validation ensure that the new device is as safe and as effective.

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).