coDiagnostiX is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in the field of application. The software reads imaging information output from medical scanners such as CBCT or CT scanners.

It is indicated for pre-operative simulation and evaluation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options, in edentulous, partial edentulous or dentition situations, which may require a surgical guide. It is further indicated for the user to design such guides for, alone or in combination, the guiding of a surgical path along a trajectory or a profile, or to help evaluate a surgical preparation or step.

coDiagnostiX software allows for surgical guide export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical guide may require to be used with accessories.

Device Description

The main uses and capabilities of the coDiagnostiX software are unchanged from the primary predicate version.

As in the primary predicate version, it is a software for dental surgical treatment planning. It is designed for the evaluation and analysis of 3-dimensional datasets and the precise image-guided and reproducible preoperative planning of dental surgeries.

The first main steps in its workflow include the patient image data being received from CBCT (Cone Beam Computed Tomography) or CT. The data in DICOM format is then read with the coDiagnostiX DICOM transfer module according to the standard, converted into 3-dimensional datasets and stored in a database.

The pre-operative planning is performed by the computation of several views (such as a virtual Orthopantomogram or a 3-dimensional reconstruction of the image dataset), by the analysis of the image data, and the placement of surgical items (i.e. sleeves, implants) upon the given views. The pre-operative planning is then followed as decided by the design of a corresponding surgical guide that reflects the assigned placement of the surgical items.

Additional functions are available to the user for refinement of the preoperative planning, such as:

· Active measurement tools, length and angle, for the assessment of surgical treatment options:
· Nerve module to assist in distinguishing the nervus mandibularis canal;
3D sectional views through the jaw for fine adjustment of surgical treatment options; .
Segmentation module for coloring several areas inside the slice dataset, e.g., jawbone, . native teeth, or types of tissue such as bone or skin, and creating a 3D reconstruction for the dataset;
Parallelizing function for the adjustment of adjacent images; and
· Bone densitometry assessment, with a density statistic in areas of interest.

All working steps are automatically saved to the patient file may contain multiple surgical treatment plan proposals which allows the user to choose the ideal surgical treatment plan. The output file of the surgical guide and/or the guided surgical is then generated from the final surgical treatment plan.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the coDiagnostiX dental implant planning and surgery planning software. It details the device's indications for use, comparison to predicate/reference devices, and non-clinical performance data used to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria for a device's performance (e.g., accuracy metrics or thresholds), nor does it describe a comparative study that proves the device meets such criteria with detailed quantitative results. The section on "Non-Clinical Performance Data" broadly discusses verification and validation, but lacks the granular data requested.

Therefore, many of the requested points cannot be answered from the provided text.

Here's an attempt to answer based on the available information, noting where information is absent:

Device: coDiagnostiX (K193301)

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Provided in Document: The document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics against such criteria. It states that "The acceptance criteria are met" for sterilization validation and "Expected results are met" for process performance qualifications, but does not provide details on what those criteria or results actually were.

2. Sample Size and Data Provenance for Test Set

Information Not Provided in Document: The document mentions "software verification and validation" and "Biocompatibility testing" but does not specify sample sizes for any test sets (e.g., number of patient scans, number of manufactured guides). There is also no explicit mention of data provenance (e.g., country of origin, retrospective/prospective collection).

3. Number and Qualifications of Experts for Ground Truth Establishment

Information Not Provided in Document: The document states "software verification and validation is conducted to assure requirements and specifications as well as risk mitigations (design inputs) are correctly and completely implemented and traceable to design outputs." However, it does not specify if experts were involved in establishing ground truth for a test set, their number, or their qualifications. The device is intended for "dental professionals who have appropriate knowledge in the field of application."

4. Adjudication Method for Test Set

Information Not Provided in Document: No information regarding an adjudication method (e.g., 2+1, 3+1, none) for a test set is provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Information Not Provided in Document: The document focuses on demonstrating substantial equivalence primarily through technological characteristics and non-clinical data, rather than through an MRMC comparative effectiveness study involving human readers. There is no mention of such a study or an effect size for human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Information Not Provided in Document: While the document refers to "software verification and validation" to demonstrate that "the software performs as intended" and "the base accuracy is identical as compared to the predicate device," it does not provide details of a standalone (algorithm only) performance study with specific metrics, such as sensitivity, specificity, or accuracy values. It implies the software's capabilities (CAD type, image sources, output files) are unchanged from the predicate, and therefore its base accuracy is "identical."

7. Type of Ground Truth Used

Information Not Provided in Document: The document does not specify the type of ground truth used for any testing. It mentions "evaluation and analysis of 3-dimensional datasets" from CBCT or CT scans, but not how ground truth (e.g., for specific anatomical features, surgical path accuracy, etc.) was established for validation purposes.

8. Sample Size for Training Set

Information Not Provided in Document: The document does not provide any information about a training set or its sample size. This is a 510(k) submission primarily comparing the device to a predicate, not detailing the development or training of an AI algorithm from scratch. The changes described are primarily feature expansions to an existing software.

9. How Ground Truth for Training Set Was Established

Information Not Provided in Document: As no information on a training set is provided, there is no information on how its ground truth was established.

Summary of Document's Approach to Meeting Requirements:

The document primarily relies on demonstrating substantial equivalence to an existing predicate device (K130724 coDiagnostiX Implant Planning Software) and reference devices rather than presenting a de novo performance study with specific acceptance criteria and detailed quantitative results.

The key arguments for substantial equivalence are:

The device has the "same intended use" as the primary predicate device.
It has "similar technological characteristics" (software, interface, inputs, outputs are either identical or considered similar with addressed impacts).
Changes are described as "feature expansions" and "minor updates" to an existing, cleared software.
Non-clinical data, including software verification and validation, biocompatibility testing, sterilization validation, and manufacturing process qualifications, are stated to have met acceptance criteria and demonstrated that the device "performs as intended" and is "safe and effective."

The non-clinical data section broadly implies that the software's core accuracy functions are maintained from the predicate device, since its fundamental CAD capabilities, image sources, and output file functions are unchanged. The new features ("planning of a surgical path along a trajectory," "planning of a surgical path along a profile," and "planning to help evaluate surgical preparation or step") are leveraged from the predicate's general implant planning and surgical planning indications. The document asserts that these changes "do not change the intended use or the applicable fundamental technology, and do not raise any new questions of safety or effectiveness."

Summary

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Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

June 21, 2021

Dental Wings GmbH % Jennifer Jackson Director of Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K193301

Trade/Device Name: coDiagnostiX Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: May 26, 2021 Received: May 27, 2021

Dear Jennifer Jackson:

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); 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,

Michael E. Adjodha, M.ChE. 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) K193301

Device Name coDiagnostiX

Indications for Use (Describe)

It is indicated for pre-operative simulation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options, in edentulous or dentition situations, which may require a surgical guide. It is further indicated for the user to design such guides for, alone or in combination, the guiding of a surgical path along a trajectory or a profile, or to help evaluate a surgical preparation or step.

coDiagnostiX software allows for surgical guide export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible and sterilizable). A surgical guide may require to be used with accessories.

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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Section 5: 510(k) Summary - coDiagnostiX 5

Submitter's Contact Information 5.1

Submitter:	Straumann USA, LLC60 Minuteman RoadAndover, MA 01810
Registration No.:	1222315 Owner/Operator No.: 9005052
On the behalf of:	Dental Wings GmbHDüsseldorfer Platz 109111 ChemnitzGermany
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023
Date of Submission:	June 17, 2021

5.2 Name of the Device

Trade Names:	coDiagnostiX
Common Name:	Dental Surgery Planning Software
Classification Name:	Bone cutting instrument and accessories
Regulation Number:	21 CFR 872.4120
Device Classification:	II
Product Code:	DZJ
Secondary Product Code(s):	LLZ
Review Panel:	Dental

Predicate Device(s) 5.3

Primary Predicate:

K130724 coDiagnostiX Implant Planning Software -
Reference Devices:
K182789 KLS Martin Individual Patient Solution (IPS) Planning System -
K112280 Straumann® CARES® Screw-retained Bridge Ti, Straumann® CARES® -Dolder® Bar Ti

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Image /page/4/Picture/0 description: The image contains the logo for "dental wings". The logo consists of a stylized blue and gray graphic on the left, followed by the text "dental wings" in a gray, sans-serif font. The graphic is a rounded shape with a blue lower portion and a gray upper portion, creating a modern and clean design.

5.4 Description

The main uses and capabilities of the coDiagnostiX software are unchanged from the primary predicate version.

Additional functions are available to the user for refinement of the preoperative planning, such as:

· Active measurement tools, length and angle, for the assessment of surgical treatment options:
· Nerve module to assist in distinguishing the nervus mandibularis canal;
3D sectional views through the jaw for fine adjustment of surgical treatment options; .
Segmentation module for coloring several areas inside the slice dataset, e.g., jawbone, . native teeth, or types of tissue such as bone or skin, and creating a 3D reconstruction for the dataset;
Parallelizing function for the adjustment of adjacent images; and
· Bone densitometry assessment, with a density statistic in areas of interest.

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Image /page/5/Picture/0 description: The image shows the logo for Dental Wings. The logo consists of a stylized icon on the left and the text "dental wings" on the right. The icon is a rounded shape with two colors: gray on the top and blue on the bottom. The text "dental wings" is in a sans-serif font and is gray in color.

The changes with respect to the coDiagnostiX predicate device version are to expand on the different surgical planning tools that can be considered as part of the predicate's general implant planning and surgical planning indications for use. The three tools are:

a) Planning of a surgical path along a trajectory this provides for a path to be determined that defines the alignment orientation of a surgical item (e.g., an implant and/or instrument).
b) Planning of a surgical path along a profile this provides for a profile surface to be determined to quide the orientation of a surgical instrument along a profile.
c) Planning of a form suitable to evaluate surgical preparation or other surgical steps this provides for a procedure to be planned with the corresponding design of a form with geometric features to evaluate the results of a surqical procedure or step.

Such planning may include the design of drill guides (planning a), cutting guides (planning b) and evaluation guides (planning c). Drill guides are manufactured from acrylate, whereby the drilling area is protected by metal. The same applies for the evaluation guides. Cutting guides are manufactured from commercially pure titanium and - if piezo-surgical instruments are applied acrylate. Note that only cutting guides are subject of this submission. Drill guides and evaluation guides are mentioned for informational purposes only. They are not subject to the premarket clearance in this K193301 submission. Manufacturing takes place at Straumann's validated manufacturing center or at the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical guide may require to be used with accessories are included or referenced in the surgical item library, as well as items which are required to be known for the surgery planning.

These changes were accommodated by changes to the GUI, adding items to the surgical item libraries, and the product's instructions for use to clarify and explain the use of the general surgery planning tool specificities. There are no changes to the base software functionalities or architecture as compared to the predicate device coDiagnostiX software.

5.5 Indications for Use of the Subject Device:

coDiagnostiX software allows for surgical guide export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM

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Image /page/6/Picture/0 description: The image contains the logo for Dental Wings. The logo consists of a stylized graphic to the left of the text "dental wings". The graphic is a rounded shape with a gray upper portion and a blue lower portion. The text "dental wings" is in a sans-serif font and is colored gray.

equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical guide may require to be used with accessories.

5.6 Substantial Equivalence Determination:

The general intended use is identical for both the subject device and primary predicate device. As to the indications for use, the general planning tools indication has been modified for the subject device coDiagnostiX as compared to its predicate device version (K130724), to also indicate three specific planning tool principles or approaches that are available with the software. The subject device also specifies the indicated patient conditions: for use in edentulous, partial edentulous, and dentition conditions. However, this is already included in the labelling of the primary predicate (K130724). Finally, the alternate workflow involving the printouts and manufacturing method using the manually operated gonyX has been removed.

Similarities and Differences to the Predicate Device

The predicate device coDiagnostiX software version (K130724) is identical or similar to the subject device' technological characteristics with regards to the software, interface requirements, as well as inputs and outputs. The surgical item library has been updated. For manufacturing at the point of care, the acrylate has been replaced by a similar acrylic resin. Central manufacturing of guides made of acrylic resin and commercially pure titanium have been added.

A technological difference is that the subject device proposes the usage of piezo-surgical cutting instruments with acrylic guides. The potential impact on substantial equivalence of this technological difference is addressed by risk analysis and testing. With the non-clinical data obtained this method is considered equivalent to the usage of a state of the art cutting device with a metal guide and does not present any new significant questions of safety or effectiveness.

Reference Devices

KLS Martin Individual Patient Solution (IPS) Planning System (K182789) has been included as reference device to leverage the increased specificity of general tool indication as part of surgery planning and surgical treatment options. KLS Martin Individual Patient Solution (IPS) Planning System is using the same technologies and methods as the subject device and is describing surgical planning tool specificities for maxillofacial treatments, which include the treatments in the oral-maxillofacial region of the subject device.

Straumann® CARES® Screw-retained Bridge Ti, Straumann® CARES® Dolder® Bar Ti (K112280) has been included as reference device to leverage individual customized titanium guides made of commercially pure titanium using subtractive manufacturing method (centralized milling).

The table below summarizes the similarities and differences between the proposed device, the predicate device, and the reference devices with respect to the intended uses and indications for use, and the device features and specifications:

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K193301 – coDiagnostiX Traditional 510(k)

Image /page/7/Picture/1 description: The image contains the logo for "dental wings". The logo consists of a stylized icon on the left and the text "dental wings" on the right. The icon is a rounded shape with two layers, the top layer is gray and the bottom layer is blue. The text is in a sans-serif font and is also gray.

Item	coDiagnostiX	coDiagnostiX	IPS	SRBB
	K193301	K130724	K182789	K112280
	(Subject Device)	(Predicate Device)	(Reference Device)	(Reference Device)
Indications forUse	coDiagnostiX is an implant planning and surgeryplanning software tool intended for use by dentalprofessionals who have appropriate knowledge in thefield of application. The software reads imaginginformation output from medical scanners such asCBCT or CT scanners.It is indicated for pre-operative simulation andevaluation of patient anatomy, dental implantplacement, surgical instrument positioning, andsurgical treatment options, in edentulous, partialedentulous or dentition situations, which may requirea surgical guide. It is further indicated for the user todesign such guides for, alone or in combination, theguiding of a surgical path along a trajectory or aprofile, or to help evaluate a surgical preparation orstep.coDiagnostiX software allows for surgical guideexport to a validated manufacturing center or to thepoint of care. Manufacturing at the point of carerequires a validated process using CAM equipment(additive manufacturing system, including softwareand associated tooling) and compatible material(biocompatible and sterilizable). A surgical guide mayrequire to be used with accessories.	coDiagnostiX is an implant planningand surgery planning software toolintended for use by dentalprofessionals who have appropriateknowledge in dental implantology andsurgical dentistry. This software readsimaging information output frommedical scanners such as CT or DVTscanners. It allows pre-operativesimulation and evaluation of patientanatomy, and dental implantplacement.For automated manufacturing of drillguides in the dental laboratoryenvironment, the coDiagnostiXsoftware allows for export of data to3D manufacturing systems.Alternatively, coDiagnostiX canprovide printouts of template plans forthe creation of surgical templatesusing a manually operated gonyXtable.	The KLS Martin Individual PatientSolutions (IPS) Planning System isintended for use as a software systemand image segmentation system forthe transfer of imaging informationfrom a medical scanner such as a CTbased system. The input data file isprocessed by the IPS PlanningSystem and the result is an outputdata file that may then be provided asdigital models or used as input to arapid prototyping portion of the systemthat produces physical outputsincluding anatomical models, guides,splints, and case reports for use inmaxillofacial surgery. The IPSPlanning System is also intended as apre-operative software tool forsimulating / evaluation surgicaltreatment options.	Straumann CARES Screw-retainedBridge Ti and Straumann CARESDolder Bar Ti are indicated for use asbares and bridges that attach to dentalimplants (Straumann implant RegularNeck (RN(Ø4.8mm and Wide Neck(WN) Ø6.5mm) in the treatment ofpartially or totally edentulous jaws forthe purpose of restoring chewingfunction.The Straumann CARES Screw-retained Bridge Ti can be designed forspecific patient size and spans thatare attached to 2 to 16 implants.The Straumann CARES Dolder Bar Tican be designed for specific patientsizes and spans that are attached to 2to 10 implants.
Classification	21 CFR 872.4120, Class II21 CFR 892.2050, Class II	21 CFR 892.2050, Class II	21 CFR 872.4120, Class II21 CFR 892.2050, Class II	21 CFR 872.3630, Class II
Product Code(s)	DZJ, LLZ	LLZ	DZJ, LLZ	NHA
Product CodeName	Bone Cutting Instruments and AccessoriesSystem, Image Processing, Radiological	System, Image Processing,Radiological	Bone Cutting Instruments andAccessoriesSystem, Image Processing,Radiological	Endosseous Dental Implant Abutment
GeneralDescription	Dental Surgery Planning System	Dental Surgery Planning System	Dental Surgery Planning System	Implant Restoration
PrescriptionUse	Yes	Yes	Yes	Yes
CoreComponent	Stand-alone software	Stand-alone software	Stand-alone software	Bar, Bridge
TargetPopulation	General public	General public	Pediatric & Adults	N/A
Item	coDiagnostiXK193301(Subject Device)	coDiagnostiXK130724(Predicate Device)	IPSK182789(Reference Device)	SRBBK112280(Reference Device)
Patientcondition	For edentulous, partial edentulous or dentitionsituations	For edentulous, partial edentulous ordentition situations	Non-specific	For edentulous or partial edentulous.
Main Features/Tools	CAD tools to manipulate/modify/render/import/export/sectioning patient models (teeth,upper/lower jaws), surgical item models, areas ofinterest.Includes:- Panoramic curve- Nerve detection- Virtual structures- Orient images to occlusal plane- Surgical item libraries- Bone density analyses, geometricmeasurements	CAD tools to manipulate/modify/render/import/export/sectioning patientmodels (teeth, upper/lower jaws),surgical item models, areas of interest.Includes:- Panoramic curve- Nerve detection- Virtual structures- Orient images to occlusal plane- Surgical item libraries- Bone density analyses,geometric measurements	CAD tools to manipulate/modify/render/import/export/sectioning patientmodels (teeth, upper/lower jaws),surgical item models, areas of interest.Includes:- Panoramic curve- Nerve detection- Virtual structures- Orient images to occlusal plane- Surgical item libraries- Bone density analyses,geometric measurements- Orthognathic modelling	N/A
Anatomical site	Oral-maxillofacial regions	Oral-maxillofacial regions	Cranio-maxillofacial regions	N/A
Specialty ofapplication /SurgicalPlanning ToolSpecificities	Surgery treatment planningSpecificities as per surgical planning tool withtreatment examples in the user manual:- Planning of a surgical path along a trajectory- Planning of a surgical path along a profile- Planning to help evaluate a surgical preparation orstepApplicable in:- Restorative Dentistry (including Endodontics andImplantology)- Oral Surgery- Maxillofacial Surgery- Periodontics- Orthodontics	Surgery treatment planningSpecificities with treatment exampleimplantation in the user manual.Applicable in:- Restorative Dentistry (includingImplantology)	Surgery treatment planningSpecificities with treatment examplebone reconstruction, orthognathicprocedures, implant design and modelcreation in the user manual.Applicable in:- Maxillofacial Surgery	N/A
Physical outputdesign perPlanning	Yes	Yes	Yes	N/A
Item	coDiagnostiXK193301(Subject Device)	coDiagnostiXK130724(Predicate Device)	IPSK182789(Reference Device)	SRBBK112280(Reference Device)
MinimumSystemRequirements	PC with specified requirements on hardware,operating system and security (in user manual)	PC with specified requirements onhardware, operating system andsecurity (in user manual)	PC with specified requirements onhardware, operating system andsecurity (in user manual)	N/A
InterfaceRequirements	Desktop Application	Desktop Application	Web Application	N/A
DICOMStandardCompliant	Yes	Yes	Yes	N/A
Image Import	- DICOM standard format data from CBCT or CT,- STL standard format from impression and/orsurface scanners	- DICOM standard format data fromCBCT or CT- STL standard format from impressionand/or surface scanners	- DICOM standard format data fromCBCT or CT- STL standard format from impressionand/or surface scanners	N/A
Export	STL file format	STL file format	STL file format	N/A
Printouts	Report/plan with patient information, screenshots,plan results	Report/plan with patient information,screenshots, plan results	Report/plan with patient information,screenshots, plan results	N/A
Guide Material	AcrylateCP Titanium	AcrylatePolystyrene	Polyamid, Titanium Alloy (Ti-6AI-4V),CP TitaniumMethacrylate (splints)	CP Titanium (no guide design, butbridge and bar on implant)
Guide Function	Cutting guide (CP Titanium or Acrylate)	Drill guide, Evaluation Guide	Marking/Cutting Guide (Polyamid,Titanium Alloy (Ti-6AI-4V), CPTitanium)Splints (Methacrylate)	N/A (no guide design)
Sterilization	Non-sterile (Steam)	Non-sterile (Steam)	Non-sterile (Steam)	Non-sterile (Steam)
ManufacturingMethod	Acrylate: Additive (Digital Light Processing (DLP))	Acrylate: Additive (Polyjet)	Acrylate: Additive (Stereolithography(SLA))	CP Titanium: Subtractive (traditional)
	CP Titanium: Subtractive	Polystyrene: gonyX (manuallyoperated)	Polyamide: Additive (Selective LaserSintering (SLS))
			Titanium Alloy: Additive (SelectiveLaser Melting (SLM))
			CP Titanium: Subtractive (traditional)
Item	coDiagnostiXK193301(Subject Device)	coDiagnostiXK130724(Predicate Device)	IPSK182789(Reference Device)	SRBBK112280(Reference Device)
GuideSpecifications	Design Volume:Min: patient specificMax: 200 mm x 200 mm x 100 mm	Not provided	Length:Min: 15 mmMax: 350 mm;Width:Min: 7 mmMax: 200 mm;Thickness:Min: 1 mmMax: 5 mm;Degree of curvature (in-plane):Min: 90°Max:180°;Degree of curvature (out of plane):Min: 60°Max: 180°	N/A
	No. of supporting points:Min: 3, arranged in a triangle	Not provided	No. of holes:Min: 2Max: Depends on length and screwhole spacing	N/A
	Supporting points distance:Max: 40 mm	Not provided	Screw hole spacing:$\ge$ 4.5 mm	N/A
	Cutting bar dimensions:Height/Thickness: $\ge$ 3 mmWidth: $\ge$ 4 mm	Not provided	Length:Min: 15 mmMax: 350 mm;Width:Min: 7 mmMax: 200 mm;Thickness:Min: 1 mmMax: 5 mm;	N/A

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Image /page/8/Picture/0 description: The image contains the logo for Dental Wings. The logo consists of a blue and white abstract shape on the left, followed by the text "dental wings" in a gray sans-serif font. The blue shape appears to be a stylized wing or leaf-like design.

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Image /page/9/Picture/0 description: The image contains the logo for "dental wings". The logo consists of a stylized, rounded shape on the left, which is divided into two sections with a gradient of gray and blue. To the right of the shape, the words "dental wings" are written in a simple, sans-serif font, with the text appearing in a light gray color.

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Image /page/10/Picture/0 description: The image contains the logo for "dental wings". The logo consists of a stylized graphic to the left of the text. The graphic is a rounded shape with two layers, the top layer is gray and the bottom layer is blue. The text "dental wings" is in a sans-serif font and is gray.

K193301 – coDiagnostiX Traditional 510(k)

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5.7 Non-Clinical Performance Data

Software verification and validation is conducted to assure requirements and specifications as well as risk mitigations (design inputs) are correctly and completely implemented and traceable to design outputs. Testing required, including functional and usability testing, shows conformity with expected results. The software documentation provides evidence that the software performs as intended and any potential risks are adequately mitigated as specified.

Software verification and validation includes the evidence that the base accuracy is identical as compared to the predicate device given that the base software (CAD type) capabilities, image sources, and output file functions are unchanged from the predicate device version of coDiaqnostiX. This is similar as to the reference device KLS Martin Individual Patient Solution (IPS) Planning System (K182789) and adequate for the respective new tool specificities and related example uses applicable under those predicate and reference devices, given they involve the same base software capabilities (CAD type) and CBCT or CT image sources, as well as the same type of output files.

Guide material types, specific compositions with its properties are similar and provided for the finished material by the material manufacturers. Stability testing is conducted to validate those properties under expected conditions of use. Results demonstrate for all guide materials used, that the properties are not degraded by sterilization or storage, with the shelf-life validated for 10 months. The material compositions are safe for the devices intended use.

Biocompatibility testing is conducted in accordance with ISO 10993-1 for the acrylates, including an assessment of the impact of material reuse. For titanium the evaluations from the reference device (K112280) are leveraged. Biocompatibility testing includes test results provided by material manufacturers, development partners and own testing. The evaluations conducted are within the acceptance criteria defined by the standard. The results demonstrate that there is no evidence that the guides applied as intended are hazardous. It adequately addresses biocompatibility. Similar testing and confirming results are available for the reference devices.

Sterilization validation is performed for steam sterilization for the acrylate quides in accordance with ISO 17665-1 to a sterility assurance level (SAL) of 10-6 using the biological indicator (BI) overkill method. For titanium quides the sterilization from the reference device (K112280), which are identical in formulation, manufacturing process and post-processing procedures, are leveraged. In addition, accuracy and stability testing was conducted after sterilization. The acceptance criteria are met. The results demonstrate that the guides are safe to sterilize for their intended use.

Process performance qualifications of the manufacturing process are conducted to assure a guide of a certain material can safely and effectively be manufactured (with the compatible 3D manufacturing system). Worst case testing of representative guide designs is utilized, including an assessment of the influence of build orientation and build location in the build space as well as of material reuse. Expected results are met. This process performance qualifications includes

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Image /page/12/Picture/0 description: The image contains the logo for Dental Wings. The logo consists of a stylized graphic on the left and the text "dental wings" on the right. The graphic is a rounded shape with a gradient of light blue to white, suggesting a wing-like form. The text "dental wings" is in a sans-serif font and is colored in gray.

centralized manufacturing and point of care procedures. The validated materials and manufacturing processes are safe and effective for their intended use.

Conclusion 6

The coDiagnostiX software has the same intended use and similar technological characteristics as the primary predicate device. The changes to increase the tool indication specificities, together with the minor updates in the software, the labeling, and the expansion of validated material and manufacturing process capabilities do not change the intended use or the applicable fundamental technology, and do not raise any new questions of safety or effectiveness. Additionally, the nonclinical testing supports that the software and its outputs, perform in accordance with the intended us and are safe and effective, and perform as well as the predicate device. The subject device has been shown to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.