NemoCast is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned dectives. It can also be applied during the treatment to inspect and analyze the progress of the treatment.

The use of the NemoCast requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Device Description

NemoCast is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes STL Models (also called dental casts) for thermoforming aligners, STL files for direct printing aligners and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). The device has no patient contact.

AI/ML Overview

This document (K232549) is a 510(k) premarket notification for the device "NemoCast," an orthodontic software. It establishes substantial equivalence to existing predicate devices, particularly 3Shape Ortho System™ (K152086) and a previous version of NemoCast (K193003).

The key takeaway is that this is primarily a software validation and substantial equivalency claim, rather than a study proving new clinical performance. The manufacturer is demonstrating that their current software performs similarly to a previously cleared version and a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and performance study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the typical format of a clinical study summary. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is the functionality of NemoCast itself, and the "study" is the comparison against the predicate devices.

The "Comparison of Intended Use and Technological Characteristics with the reference Device" table (pages 7-8) serves as the primary evidence of meeting "acceptance criteria" for substantial equivalence. It lists various features and functions, and for each, it aims to show "None" under "Differences" or a difference that does not affect safety and effectiveness.

Here's a condensed version of how that table functions as a de facto "acceptance criteria" and "performance report":

Feature	Acceptance Criteria (Implied by Predicate)	NemoCast Performance (Reported)
Product Code	PNN, LLZ	PNN, LLZ
Common Name	Orthodontic Software	Orthodontic Software
Classification Name	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket
Regulation Number	21 CFR 872.5470	21 CFR 872.5470
Supported anatomic areas	Maxilla and Mandible	Maxilla and Mandible
Use by dental professionals in orthodontic treatment planning	Yes (NemoCast K193003: "only before treatment")	Yes (NemoCast K232549: "before, during, after treatment") Difference noted: broadened scope compared to reference device, but aligned with primary predicate.
Management of patients and models	Yes	Yes
Inspection, measurement and analysis of orthodontic models	Yes	Yes
Treatment simulation	Yes	Yes
Virtual appliance preparation, handling and export	Yes	Yes
Provide digital file and device output	Yes (STL files for dental casts)	Yes (STL files for dental casts, and additionally indirect Bonding Transfer Media)
Supported PC formats	Windows	Windows
Creating, editing, deleting and copying patient data	Yes	Yes
Creating, editing, deleting and copying case data	Yes	Yes
Surface scan from intra-oral scanner	Yes	Yes
Surface scan from STL, PLY, OBJ file	Yes (Predicate: STL only)	Yes (STL, PLY, OBJ) Difference noted: Broader import formats, stated not to affect security/safety.
CT image data	DICOM	DICOM
2D overlay	PNG, JPG, BMP	PNG, JPG, BMP
Aligning surface scan and CT image	Yes	Yes
Aligning cephalometric images	Yes	Yes
Alignment of surface scan with 2D overlays	Yes	Yes
Ability to check/adjust DICOM visibility	Yes	Yes
DICOM scan segmentation	Yes	Yes
Occlusal Orientation	Yes (Reference Device) / No (Predicate Device)	Yes Difference noted: Feature present in subject and reference, not in primary predicate.
Segmenting teeth roots	Yes (Reference Device) / No (Predicate Device)	Yes Difference noted: Feature present in subject and reference, not in primary predicate.
DICOM orientation	Yes	Yes
2D measurement toolbox	Yes	Yes
3D measurement toolbox	Yes	Yes
Arch shape analysis	Yes	Yes
Wire length analysis	Yes	Yes
Tooth width analysis	Yes	Yes
Bolton analysis	Yes (Predicate Device) / No (Reference Device)	Yes
Space analysis	Yes	Yes
Overjet/overbite analysis	Yes (Predicate Device) / No (Reference Device)	Yes
Occlusion map	Yes	Yes
Treatment analysis and report generation	Yes	Yes
2D & 3D simulation	Yes	Yes
Orthodontic appliance search	Yes	Yes
Orthodontic appliance virtual preparation	Yes	Yes
Orthodontic appliance design	Yes	Yes
Orthodontic appliance export	Yes	Yes
Virtual articulator	Yes	Yes
Intended User	Dental Professionals	Dental Professionals
Intended Patient Population	Patients requiring Orthodontic Treatment (Predicate) / Adults requiring Orthodontic Treatment (Reference)	Patients requiring Orthodontic Treatment Difference noted: Aligned with primary predicate.

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

The document states: "The performance testing remains unchanged from the company's own reference device submission, NemoCast K193003. The performance testing for the subject device is being leveraged from the company's own reference device including: design verification and validation testing."

This implies that the sample size and data provenance for the current 510(k) submission are not new. They are relying on previous testing. The document does not explicitly state the sample size (number of cases/patients) or the data provenance (e.g., country of origin, retrospective/prospective) for the test set. This information would typically be found in the original K193003 submission or internal validation reports, which are not detailed here.

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

This information is not provided in the document. As this is a software substantial equivalence submission leveraging previous testing, details about the ground truth establishment for the test set (number and qualifications of experts) are not specified here.

4. Adjudication method for the test set

This information is not provided in the document.

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

No, a MRMC comparative effectiveness study demonstrating improved human reader performance with AI assistance was not done for this submission. The "NemoCast" device is described as a "medical front-end device providing tools for management... analysis, treatment simulation, and virtual appliance design." It is a planning and design software, not an AI-assisted diagnostic tool that would typically involve a human-in-the-loop MRMC study for assessing reader improvement.

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

The document mentions "The software is thoroughly tested in accordance with a documented test plan. This test plan is derived from the specifications and ensures that all controls and features are functioning properly. The software is validated together with end-users." This general statement indicates functional and validation testing that would assess standalone performance (software functioning as intended). However, specific quantifiable metrics of "algorithm-only" performance (e.g., accuracy of automatic measurements) are not reported in this summary. The focus is on the functional equivalence of the tools provided within the software.

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

The document does not explicitly state the type of "ground truth" used for the underlying validation of the software's measurements or simulations. Given the nature of orthodontic planning software, ground truth for features like measurements or segmentations would typically be established through:

Expert consensus: Manual measurements or segmentations performed by experienced orthodontists on 3D models.
Physical measurements/phantom data: Validation against known physical dimensions or phantom models.

However, these details are not provided in this 510(k) summary.

8. The sample size for the training set

This information is not provided. As this is a software product, not necessarily one relying on a large deep learning model needing a defined "training set" in the context of AI development for image interpretation, this detail might not be applicable or explicitly stated. If there are features utilizing machine learning (which is not explicitly detailed but possible for functions like segmentation), the training set details are not included. The submission is focused on demonstrating functional equivalence.

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

This information is not provided and is likely not applicable in the context of this 510(k) submission, as it focuses on demonstrating substantial equivalence of a software tool rather than a novel AI algorithm with a distinct training phase. If machine learning components exist, the process for establishing their "training ground truth" is not disclosed here.

In summary, the provided text details a 510(k) submission for substantial equivalence. It does not contain the detailed clinical study information (like sample sizes, expert qualifications, adjudication methods, or MRMC study results) that would typically accompany a submission for a novel diagnostic AI device where independent performance validation is the primary focus. Instead, it relies on demonstrating that the updated software (NemoCast K232549) is functionally equivalent to its predicate devices (NemoCast K193003, 3Shape Ortho System™ K152086) and that any differences do not impact 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

November 21, 2023

Software Nemotec S.L. % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127

Re: K232549

Trade/Device Name: NemoCast Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: August 23, 2023 Received: August 23, 2023

Dear Kevin Walls:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA 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) K232549

Device Name

NemoCast

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

즈 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the letters in a dark blue color. Below the word "NEMOTEC" is the phrase "A BIOTECH DENTAL COMPANY" in a smaller, lighter blue font. To the right of the text is a circular graphic with a dark blue circle in the center and three light blue segments around it.

510(K) Summary - K232549

This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant Information:

Software Nemotec S.L.

Av. Juan Caramuel, №1

Leganés, Madrid, Spain, 28919

Submission Correspondent:

Kevin Walls Principal Consultant, Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127

Device Information:

Trade Name:	NemoCast
Common Name:	Orthodontic Software
Classification Name:	Orthodontic Plastic Bracket
Classification Regulation:	21CFR 872.5470
Device Class:	II
Product Code:	PNN, LLZ

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Image /page/5/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the "NEMO" in a darker blue and the "TEC" in a lighter blue. Below the name is the text "A BIOTECH DENTAL COMPANY" in a smaller, lighter font. To the right of the name is a circular graphic divided into three sections of varying shades of blue, with a dark blue circle in the center.

Reference Device:

NemoCast, Software Nemotec, K193003

Primary Predicate:

3Shape Ortho System™, 3Shape A/S, K152086

Date Prepared:

Aug 08, 2023

Predicate Device:

The NemoCast Software has the same intended uses and technical characteristics as primary predicate 3Shape Ortho System™ (K152086) from 3Shape A/S and reference predicate NemoCast from Software Nemotec (K193003) as listed in the table below:

Based on the information and supporting documentation provided, the NemoCast Software and the primary predicate (3Shape Ortho System™) have the same intended use.

Both software devices are used by Dental Professionals in orthodontic treatment planning (before, during, after treatment) covering management of patients and models, inspection, 2D and 3D measurement and orthodontic analysis of models, 2D & 3D treatment simulation, as well as virtual appliance preparation, handling and export, and they are both providing device output. Additionally, the indirect bonding functionality of both systems is intended for use with commercially available brackets and wires. Therefore, the NemoCast Software and the primary predicate (3Shape) are found to be similar in their intended use, supported anatomic areas and the majority of the available features and functionalities.

Device Description:

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Image /page/6/Picture/0 description: The image is a logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the first three letters in a darker blue and the last four letters in a lighter blue. Below the word "NEMOTEC" is the phrase "A BIOTECH DENTAL COMPANY" in a smaller, sans-serif font. To the right of the word "NEMOTEC" is a circular graphic divided into three sections, with a smaller circle in the center.

Indications for Use:

NemoCast is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. It can also be applied during the treatment to inspect and analyze the progress of the treatment.

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Image /page/7/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in large, bold, dark blue letters. Below the word "NEMOTEC" is the phrase "A BIOTECH DENTAL COMPANY" in smaller, light blue letters. To the right of the text is a circular graphic with three sections in different shades of blue and a dark blue circle in the center.

Comparison of Intended Use and Technological Characteristics with the reference Device:

Substantial Equivalence Table
Feature name	SUBJECTDEVICENemoCast	REFERENCEDEVICENemoCast(K193003)	PRIMARYPREDICATE3Shape OrthoSystem ™,K152086	Differences
Product Code	PNN, LLZ	PNN, LLZ	PNN, LLZ	None
Common Name	OrthodonticSoftware	OrthodonticSoftware	OrthodonticSoftware	None
Classification Name	OrthodonticPlasticBracket	OrthodonticPlastic Bracket	OrthodonticPlastic Bracket	None
Regulation Number	21 CFR872.5470	21 CFR872.5470	21 CFR872.5470	None
Supported anatomic areas	Maxilla andMandible	Maxilla andMandible	Maxilla andMandible	None
Intended Use
Use by dental professionals inorthodontic treatmentplanning (before, during, aftertreatment).	Yes	Yes	Yes	Reference deviceNemoCast wasused by dentalprofessionalsonly beforetreatment.
Management of patients andmodels.	Yes	Yes	Yes	None
Inspection, measurement andanalysis of orthodonticmodels.	Yes	Yes	Yes	None
Treatment simulation.	Yes	Yes	Yes	None
Virtual appliance preparation(including dental casts),handling and export.	Yes	Yes	Yes	None
Provide digital file and deviceoutput.	Yes	Yes	Yes	All 3 devicesoutput STL filesfor fabrication ofdental casts.The subjectDevice andpredicate Device
				both additionallyoutput indirectBonding TransferMedia.
Supported PC formats	Windows	Windows	Windows	None
Managing patient and case base data:
Creating, editing, deletingand copying patient data	Yes	Yes	Yes	None
Creating, editing, deletingand copying case data	Yes	Yes	Yes	None
Collection of study material
Surface scan fromintra-oral scanner	Yes	Yes	Yes	None
Surface scan from STL, PLY,OBJ file	Yes	No	Yes, only STL	Althoughpredicate deviceonly import STLformat, the OBJand PLY formatsare otherequivalentformats which donot affect thesecurity andsafety of thedevice.
CT image data	DICOM	DICOM	DICOM	None
2D overlay	PNG, JPG,BMP	PNG, JPG,BMP	PNG, JPG,BMP	None
Alignment of study material
Aligning surface scan andCT image	Yes	Yes	Yes	None
Aligning cephalometricimages	Yes	Yes	Yes	None
Alignment of surface scanwith 2D overlays	Yes	Yes	Yes	None
Ability to check/adjustDICOM visibility	Yes	Yes	Yes	None
DICOM scan segmentation	Yes	Yes	Yes	None
Occlusal Orientation	Yes	Yes	No	Although thepredicate devicedoes not performocclusal
				orientation, the
				reference device
				contains this
Segmenting teeth roots	Yes	Yes	No	option.Although the
				predicate device
				does not
				segment teeth
				roots, the
				reference device
				contains this
				option.
DICOM orientation	Yes	Yes	Yes	None
Measuring study material
2D measurement toolbox	Yes	Yes	Yes	None
3D measurement toolbox	Yes	Yes	Yes	None
Analyzing study material
Arch shape	Yes	Yes	Yes	None
Wire length	Yes	Yes	Yes	None
Tooth width	Yes	Yes	Yes	None
Bolton	Yes	No	Yes	None
Space analysis	Yes	Yes	Yes	None
Overjet/overbite	Yes	No	Yes	None
Occlusion map	Yes	Yes	Yes	None
Treatment analysis andreport generation	Yes	Yes	Yes	None
Treatment simulation

2D & 3D simulation	Yes	Yes	Yes	None
Virtual appliance design
Orthodontic appliancesearch	Yes	Yes	Yes	None
Orthodontic appliance	Yes	Yes	Yes	None
virtual preparation
Orthodontic appliancedesign	Yes	Yes	Yes	None
Orthodontic applianceexport	Yes	Yes	Yes	None
Virtual articulator	Yes	Yes	Yes	None

Indications for Use	NemoCast is	NemoCast is	3Shape Ortho	The indications
	intended for	intended for	System™ is	for use for the 3
	use as a	supporting the	intended for	devices are the
	medical	diagnostic and	use as a	same, with the
	front-end	treatment	medical	exception of the
	device	plan processes	front-end	virtual design
	providing	for	device	options.
	tools for	orthodontic	providing	(Compared to the
	management	procedures	tools for	reference device,
	of	related to	tools for	the Subject
	orthodontic	minor anterior	management	Device
	models,	tooth	of orthodontic	additionally is
	systematic	movements; it	models,	used for design
	inspection,	provides tools	systematic	of Indirect
	detailed	for	inspection,	Bonding Transfer
	analysis,	management	detailed	Media.
	treatment	of orthodontic	analysis,
	simulation	models,	treatment	The Subject
	and virtual	systemic	simulation and	Device virtual
	appliance	inspection,	virtual	design options
	design	detailed	appliance	are the same as
	options	analysis,	design options	the Virtual design
	(Export of	treatment	(Custom Metal	options for the
	Models,	simulation	Bands, Export	predicate
	Indirect	and virtual	of Models,	Device.)
	Bonding	appliance	Indirect
	Transfer	design options	Bonding
	Media) based	(export of	Transfer
	on 3D models	models) based	Media) based
	of the	on 3D models	on 3D models
	patient's	of the	of
	dentition	patient's	the patient's
	before the	dentition	dentition
	start of an	before the	before the start
	orthodontic	start of an	of an
	treatment. It	orthodontic	orthodontic
	can also be	treatment. It	treatment. It
	applied	can also be	can also be
	during the	applied to	applied during
	treatment to	evaluate if the	the treatment
	inspect and	outcome is	to inspect and
	analyze the	consistent	analyze the
	progress of	with	progress of the
	the	the	treatment. It
	treatment. It	planned/desir	can be used at
	can be used	ed treatment	the end of the
	at the end of	objectives.	treatment to
	the treatment	NemoCast	evaluate if the
	to evaluate if	requires the	outcome is
	the outcome	user to have	consistent with

	is consistentwith theplanned/desired treatmentobjectives. Itcan also beappliedduring thetreatment toinspect andanalyze theprogress ofthetreatment.The use oftheNemoCastrequires theuser to havethe necessarytraining anddomainknowledge inthe practiceoforthodontics,as well as tohave receiveda dedicatedtraining in theuse of thesoftware.	the necessarytraining anddomainknowledge inthe practice oforthodontics,as wellas to havereceived adedicatedtraining in theuse of thesoftware.	theplanned/desired treatmentobjectives.The use of theOrthoSystemTMrequires theuser to havethe necessarytraining anddomainknowledge inthe practice oforthodontics,as well as tohave received adedicatedtraining in theuse of thesoftware.
Intended User	DentalProfessionals	DentalProfessionals	DentalProfessionals	None
Intended PatientPopulation	PatientsrequiringOrthodonticTreatment	AdultsrequiringOrthodonticTreatment	PatientsrequiringOrthodonticTreatment	The intendedpatientpopulation forthe subjectdevice is thesame as thepredicate device.The referencedevice intendedpatientpopulation was

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Image /page/8/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the first four letters in a darker blue and the last three in a lighter blue. Below the company name, the words "A BIOTECH DENTAL COMPANY" are written in a smaller font. To the right of the company name is a circular graphic with a dark blue dot in the center and three sections in different shades of blue surrounding the dot.

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Image /page/9/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the letters in a dark blue color. Below the company name is the text "A BIOTECH DENTAL COMPANY" in a smaller, lighter font. To the right of the company name is a circular graphic with a dark blue dot in the center.

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Image /page/10/Picture/0 description: The image shows the word "NEMOTEC" in blue font, with the words "A BIOTECH DENTAL COMPANY" in smaller font underneath. To the right of the word "NEMOTEC" is a circular logo with a blue dot in the center. The logo is made up of three different shades of blue.

Image /page/10/Picture/1 description: The image shows a circular diagram divided into three sections. The sections are colored in varying shades of blue, with the darkest shade at the top right, a medium shade at the bottom, and the lightest shade at the top left. There is a solid dark blue circle in the center of the diagram.

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Image /page/11/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the letters in a dark blue color. Below the company name, the words "A BIOTECH DENTAL COMPANY" are written in a smaller, lighter blue font. To the right of the company name is a circular graphic with a dark blue circle in the center.

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Image /page/12/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the first two letters in a darker blue and the rest in a lighter blue. Below the company name, the words "A BIOTECH DENTAL COMPANY" are written in a smaller, sans-serif font. To the right of the company name is a circular graphic with three sections in different shades of blue and a white circle in the center with a dark blue dot.

TECHNOLOGICAL CHARACTERISTICS

NemoCast; Software Nemotec, is software for simulating/evaluating orthodontic treatment programmed in C++ language and running on the Windows operating system.

TESTING & VALIDATION

The software is thoroughly tested in accordance with a documented test plan. This test plan is derived from the specifications and ensures that all controls and features are functioning properly. The software is validated together with end-users.

The performance testing remains unchanged from the company's own reference device submission, NemoCast K193003. The performance testing for the subject device is being leveraged from the company's own reference device including: design verification and validation testing.

Differences:

The Indications for Use statement between the subject and predicate devices are equivalent; minor differences in wording do not alter the intended use of the subject device. In addition, there are minimum differences in the software functions or technical requirements; none of these differences affect the safety and effectiveness of the subject device relative to the predicate, both can be considered equivalent.

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.