exoplan is a medical software, intended to support the 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 guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representive situation and approved implant positions. 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 current Microsoft Windows operating system (7, 8.1,10, 64 Bit), off-the shell GPU card and otherwise standard peripheral components.

The device allows importing 3D CT data and dental scan data (e.g. 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 dental 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 Implant Libraries that contain information provided by the original manufacturer of a respective physical implant, reconstruction parts on top of the implant, such as stock abutments or titanium bases. Libraries also contain drilling sleeves and tools of surgical kit items, such as drills and drill handles. The libraries are digitally signed and by that any modification of a library content or the referred library parts of files will be detected by exoplan reported to the user and documented in an Implant Planning Report or Surgical Protocol document.

exoplan has no contact with the patient.

AI/ML Overview

The provided document is a 510(k) summary for the medical software "exoplan 2.3". It outlines the device's indications for use, technical characteristics, and a comparison to a predicate device. The document does not contain details about a clinical study involving human readers or a multi-reader multi-case (MRMC) study. It primarily focuses on the device's technical performance and verification/validation steps.

Here's an analysis of the acceptance criteria and the study information that is available in the document:

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

The document includes a table titled "Summary of tests and accuracy results" on page 5, which lists several tested accuracies (acting as acceptance criteria) and their reported results.

#	Tested Accuracy	Reported Device Performance
1.	Visualization of iso-surface of CT data accuracy	10% of the maximum voxel size (e.g., for 1mm voxel size, accuracy is 0.1mm)
2.	Density threshold accuracy in 3D CT data	10% of maximum voxel size for a perfectly selected threshold.
3.	Accuracy of distance measurement in 3D CT data, rendering modes "iso-surface", "solid"	General dimensional measurement accuracy of 0.01mm. Clicking on DICOM object in iso-surface or solid rendering mode has an additional limitation of 10% of the voxel size.
4.	Accuracy of distance measurement in STL meshes	Achievable accuracy of 0.01mm.
5.	Accuracy of angle measurement	Achievable accuracy of 0.5°.
6.	CT Data alignment accuracy, 3 Point Alignment & Best Fit Alignment	3 Point Alignment: Achievable accuracy: 1mm. Best Fit Alignment: Achievable accuracy depends on input data resolution; for the data set used, 0.2mm.
7.	Implant placement accuracy	Achievable accuracy of 0.3 mm relative to CT data.
8.	Collision detection accuracy, visual	Collisions are detected: Implant/implant, marked nerve/implant, collision object mesh/implant.
9.	Collision detection accuracy	0.01mm.
10.	Drill Sleeve placement accuracy	Accuracy of placing a sleeve along the implant axis: 0.01mm.
11.	Drill Sleeve rotation accuracy	Achievable repetitious accuracy of 1°.
12.	Accuracy of Surgical Guide bottom	0.1mm in smooth areas without undercuts (relative to optical scan data plus user-defined offset).
13.	Accuracy of merged Surgical Guide parts	0.01mm in smooth areas (relative to the surface of the merged parts).
14.	Accuracy of merged Surgical Guide bottom	0.01mm in smooth areas (relative to the surface of the merged bottom).

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

The document states: "Software verification and validation is performed in accordance with the applicable guidance document... Prior to release of exoplan the verification and validation of the device has been completed." It also mentions "The selected tests verify accuracies of critical items in the whole workflow of exoplan".

However, the document does not explicitly state the sample size for the test set used for these accuracy measurements. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the CT/CBCT or optical scan data used in these tests. It only mentions the data types (CT/CBCT, optical scans) and that they originate "from other medical devices".

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

The document does not mention the use of experts or their qualifications for establishing ground truth for the technical accuracy tests. The described tests appear to be technical verification and validation, likely against known or measured physical/digital standards, rather than expert-derived diagnoses or interpretations.

4. Adjudication method for the test set:

Since the document does not describe expert involvement in establishing ground truth for the technical tests, there is no adjudication method mentioned.

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 on page 5: "Clinical testing is not a requirement and has not been performed." This indicates that no MRMC or other human-in-the-loop performance study has been conducted or reported in this submission. Therefore, no effect size of human reader improvement with AI assistance is provided.

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

The provided "Summary of tests and accuracy results" table (page 5) describes the performance of the "exoplan" software itself, independent of human interaction beyond input provision. These are essentially standalone performance metrics focusing on the accuracy of its various computational and visualization functions (e.g., measurement accuracy, alignment accuracy, collision detection accuracy).

7. The type of ground truth used:

For the technical accuracy tests, the ground truth appears to be engineering ground truth or digital ground truth, derived from:

Pre-defined voxel sizes and known physical dimensions for measurements.
Known "perfectly selected thresholds" for density.
Physical or digital models with established properties for alignment, implant placement, and guide fit.
The software's internal calculations and comparisons for collision detection and merging parts.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these technical accuracy tests.

8. The sample size for the training set:

The document is a 510(k) summary for a "Picture archiving and communications system" that assists with dental implant planning. While it's software-based, the description of its functionalities (e.g., using "Implant Libraries" which contain manufacturers' data) suggests it might not be a machine learning/AI device in the sense that it requires a "training set" in the conventional machine learning context. The document does not mention any training set size because it doesn't describe an AI model that undergoes a training phase from data.

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

As no training set is mentioned or implied for a machine learning model, this information is not applicable and not provided in the document. The software appears to be rule-based or model-based, relying on geometric, anatomical, and manufacturer-provided data rather than learning from a large labeled dataset.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 6, 2019

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

Re: K183458

Trade/Device Name: exoplan 2.3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 25, 2019 Received: July 3, 2019

Dear Mr. 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.

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) K183458

Device Name

exoplan 2.3

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)

K183458

Submitter Information

exocad GmbH 37 Julius-Reiber-Strasse Darmstadt, HE 64293 Germany Contact Person: Stefan Walter, Quality Manager Phone: +49-6151-629489-0 fax: +49 6151-629489-9

Establishment Registration number: 3011521456

Date prepared: 2019-08-05

Manufacturing Facility

Same as submitter.

Device Information

Trade/proprietary Name:	exoplan 2.3
Common Name/Usual name:	Dental Implant Planning and tooth retained Surgical Guidedesign software application
Device Classification Name:	Picture archiving and communications 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:	K152078
Predicate device:	Implant Studio™ 2015
Manufacturer:	3Shape A/S, Holmens Kanal 7, DK-1060 Copenhagen K

Intended 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 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. 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 to conventional (non-guided) surgery.

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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 current Microsoft Windows operating system (7, 8.1,10, 64 Bit), off-the shell GPU card and otherwise standard peripheral components.

exoplan has no contact with the patient.

Note! In the US, the physical surgical guide for endosseous dental implant placement is a medical device to be manufactured at an FDA reqistered and listed manufacturing location.

Non-clinical Testing

Software verification and validation is performed in accordance with the applicable quidance document ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005). Prior to release of exoplan the verification and validation of the device has been completed. Each user requirement and each product requirement derived thereof has an own acceptance criteria. Detected anomalies are evaluated, resolved or where appropriate in case of a minor issue described in the release notes. The verification and validation includes the verification and where appropriate validation of the risk mitiqation measure as defined by the risk analysis. Feedback of software testers and feedback from validation is regarded in the device as appropriate.

Summary of tests and accuracy results

This section lists several tests that verify important accuracies in various working steps in the exoplan workflow as can be achieved with the exoplan software. The selected tests verify accuracies of critical items in the whole workflow of exoplan:

3D CT data visualization accuracy -
-Density threshold accuracy
-Measurement accuracy
CT data to optical scan data alignment accuracy -
lmplant placement accuracy
-Collision detection accuracy
-Sleeve placement accuracy
Rotation marker accuracy -
-Accuracy of surgical guide bottom compared to jaw scan
-Accuracy of merged output compared to individual parts (mount, surgical guide top)
Accuracy of merged surgical guide fit on surgical guide bottom

The following table provides an overview on the tests above and the achieved accuracy.

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exoplan 510(k) Summary

Image /page/5/Picture/1 description: The image shows the word "exocad" in a bold, sans-serif font. The color of the text is a dark purple. The word is positioned horizontally in the image. There is a horizontal purple line below the word.

#	Tested Accuracy	Result
	3D CT data visualization accuracy
1.	Visualization of iso-surface of CT data accuracy	accuracy of visualization of 3D CT data is 10% of the maximum voxelsize (voxel size: 1mm, therefore accuracy 0.1mm)
	Density threshold accuracy
2.	Density threshold accuracy in 3D CT data	visualization accuracy for a perfectly selected threshold is 10% ofmaximum voxel size.
	Measurement accuracy
3.	Accuracy of distance measurement in 3D CT data,rendering modes "iso-surface", "solid"	In general, dimensional measurement has an accuracy of 0.01mm.Clicking on DICOM object in iso-surface or solid rendering mode has anadditional limitation of 10% of the voxel size
4.	Accuracy of distance measurement in STL meshes	Achievable accuracy of dimensional measurements in mesh data:0.01mm
5.	Accuracy of angle measurement	achievable accuracy of measurement of angles in mesh data: 0.5°
	CT data to optical scan data alignment accuracy
6.	CT Data alignment accuracy, 3 Point Alignment &Best Fit Alignment	3 Point Alignment, achievable accuracy: 1mmBest Fit Alignment, in general the achievable accuracy depends on theresolution of the input data. For this data set the achievable accuracy is0.2mm
	Implant placement accuracy
7.	Implant placement accuracy	Achievable accuracy of 0.3 mm relative to CT data
	Collision detection accuracy
8.	Collision detection accuracy, visual	Collisions are detected:Implant/implant, marked nerve/implant, collision object mesh/implant
9.	Collision detection accuracy	Collision detection accuracy: 0.01mm
	Sleeve placement accuracy
10.	Drill Sleeve placement accuracy,	Accuracy of placing a sleeve along the implant axis: 0.01mm
	Rotation marker accuracy
11.	Drill Sleeve rotation accuracy,	Achievable repetitious accuracy of 1°
	Accuracy of surgical guide bottom compared to jaw scan
12	Accuracy of Surgical Guide bottom,	Accuracy of the surgical guide bottom to the optical scan data plus theuser defined offset is 0.1mm in smooth areas without undercuts
	Accuracy of merged output compared to individual parts (mount, surgical guide top)
13.	Accuracy of merged Surgical Guide parts	Accuracy of the surgical guide individual parts to the surface of themerged parts is 0.01mm in smooth areas
	Accuracy of merged surgical guide fit on surgical guide bottom
14	Accuracy of merged Surgical Guide bottom,	Accuracy of the surgical guide bottom to the surface of the mergedbottom is 0.01mm in smooth areas

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 predicate device:

510(k) Number: K152078

Implant Studio™ 2015 Predicate device:

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

ComparableCriteria	Predicate device	Device under evaluation	Eval.
Trade/proprietaryName, 510(k) #:	K152078, Implant Studio™ 2015	exoplan	---
DeviceClassificationName:	Picture archiving and communicationssystem	Picture archiving and communications system	Identical
RegulationNumber:	892.2050	892.2050	Identical
Classification:	Class II	Class II	Identical
Product Code:	LLZ	LLZ	Identical
Prescription/over the counteruse	Prescription use	Prescription use	Identical
Intended use /indications /description	Implant Studio™ is indicated for use asmedical front-end software that can beused by medically trained professionalsfor the purpose of visualizing gray valueimages. It is intended for use as pre-operative planning software for theplacement of dental implant(s) based onimported CT image data, optionallyaligned to an optical 3D surface scan.Virtual Crowns can be used foroptimized implant positioning under theprosthetic aspect. The digital threedimensional model of a surgical guidefor a guided surgery can be designedbased on the approved implant position.This 3D data can be exported tomanufacture a separate physicalproduct. Indications of the dentalimplants do not change with guidedsurgery compared to conventionalsurgery. Use of the software requiresthat the user has the necessary medicaltraining in implantology and surgicaldentistry.	exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization ofthe implant placement within images of the patient's anatomy.The process is based on CT/CBCT data sets originating fromother 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 theplacement of endosseous dental implants in guided surgery. Thedesign of surgical guides is based on 3D surface datarepresenting the preoperative situation and approved implantpositions. The software exports the planning and design resultsas geometrical data and a digital 3D model of the surgical guideto support the manufacture of a separate physical product.exoplan does not extend or change indications of dentalimplants. Usage of a surgical guide designed with the softwaredoes not change the necessary due diligence required comparedto conventional (non-guided) surgery.The software is intended to be used only by dental professionalswith sufficient medical training in dental implantology andsurgical dentistry in office environments suitable for readingdiagnostic dental DICOM data sets. exoplan shall not be usedfor any purpose other than planning dental implant placement ordesign of surgical guides.	Equivalent
Users	necessary medical training inimplantology and surgical dentistry	dental professionals with sufficient medical training in dentalimplantology and surgical dentistry	Equivalent
Input data	CT image data andoptical surface scan	CT image data andoptical surface scan	Identical
Registration /Alignment	Registration / Alignment of CT imagedata and optical surface scan	Registration / Alignment of CT image data andoptical surface scan	Identical
Output data	surgical report, drill protocol is provided,STL file with designed guide formanufacturing	Implant planning report, surgical protocol, STL file with designedguide for manufacturing	Equivalent
Handling of riskstructures	Definition of mandibular nerve canal,collision detection with implant duringimplant planning	Definition of mandibular nerve canal, collision detection withimplant during implant planning	Equivalent
Surgical guidemanufacturing	Transfer to a manufacturing site.	Transfer to a manufacturing site.	Identical
Hardware	Any compatible of-the shelf PC, GPU,monitor and network connection	Any compatible off-the-shelf PC with a dedicated GPU, monitorand network connection	Identical
Gui OS	Windows ® 7, 8.1, 10 ; 32 and 64 bitOperating System	Windows ® 7, 8.1, 10 ; 64 bit Operating System	Equivalent

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Based on the comparison of intended use, principles of operation, features, characteristics, technical data and results of the verification and validation, we conclude that exoplan is substantially equivalent to the predicate device 3Shape, Implant Studio™ 2015, and therefore safe to use as intended.

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).