The TECHFIT Diagnostic Models are patient-specific devices intended to be used as a pre-operative planning tool for treatment in the field of maxillofacial surgery.

The input data file (DICOM imaging information from a medical scanner file) is processed by commercial off-the-shelf software, and the result is an output data file that may then be provided as digital models or used as input to produce physical anatomic models using additive manufacturing.

The physical replica can be used for diagnostic purposes in the field of, maxillofacial applications.

TECHFIT Diagnostic Models should be used in conjunction with other diagnostic tools and expert clinical judgment.

TECHFIT Diagnostic Models are not intended to enter the operating room

Device Description

TECHFIT Diagnostic Models are virtual and additive manufactured anatomic models intended for diagnostic use during maxillofacial surgery planning.

The models are created from a CT scan of the patient's anatomy, which is segmented through Commercial-Off-The-Shelf (COTS) software and converted into virtual 3D models. The surgeon uses these 3D models to make the initial plan/diagnosis based on examination or physical measurement of the patient's anatomy, this includes planning anatomic structures movements (for example, maxilla and mandible movements for occlusion), the resections, measurement of anatomic distances (e.g., the facial symmetry), and determining fixation points and the size and shape of the implants if requested. These functions are those that the surgeon can perform, not functions that the subject device provides by itself.

TECHFIT creates a design proposal for the case based on the information given by the medical professional and the process continues until the final design proposal is approved. Finally, the digital file can be used as an input to produce physical anatomic models through additive manufacturing.

TECHFIT Diagnostic Models are intended for single use only.

AI/ML Overview

The provided text describes the TECHFIT Diagnostic Models, which are patient-specific devices intended for pre-operative planning in maxillofacial surgery. The device processes DICOM imaging data to create virtual 3D models or physical anatomical models through additive manufacturing.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
3D Printing process validation	The manufacturing process correctly prints TECHFIT Diagnostic Models.	"The acceptance criteria were met." (Details not specified, but likely refers to successful execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)).
Dimensional Validation	All measurements must comply with the acceptance criterion (implied accuracy within a certain tolerance when comparing original models to scanned 3D-printed models).	"All the measurements complied with the acceptance criterion." (Specific numerical tolerance/criterion for dimensional accuracy is not provided.)
Packaging Validation	The packaging system must successfully undergo simulated shipment and environmental conditioning as per ASTM D4169-16 and ISTA 3A, without compromising the device.	"The acceptance criteria were met." (Indicates successful completion of tests without damage to the product or packaging integrity.)
Diagnostic Qualitative Evaluation	Maxillofacial surgeons must deem the models diagnostically significant and helpful for identifying pathologies and planning surgical interventions when used with other diagnostic tools.	"The interviewed surgeons deemed TECHFIT Diagnostic models a significant help when it comes to identifying different pathologies and plan a more precise surgical intervention when used in conjunction of other diagnostic tools."
Fidelity Validation of detectable anatomical landmarks	All selected landmarks in the educational anatomic model must be identified in both the virtual and 3D-printed models, maintaining dimensional accuracy.	"All selected landmarks in the educational anatomic model were identified in the virtual models and the 3D printed models." (Implies successful replication of landmarks and retention of dimensional accuracy, though specific metrics for accuracy are not detailed.)

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

Dimensional Validation: "multiple anatomic models from different patients (mandibles and maxilla)" were used. The exact number of patients or models is not specified.
Diagnostic Qualitative Evaluation: The number of clinicians interviewed is not specified, only referred to as "interviewed surgeons".
Fidelity Validation of detectable anatomical landmarks: "educational anatomic models" were used. The number of models or specific types is not provided.
Data Provenance: Not explicitly stated whether the patient data used for dimensional validation was retrospective or prospective, or its country of origin. The use of "educational anatomic models" for landmark fidelity implies a non-clinical, potentially synthetic, origin for that specific test.

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

Dimensional Validation: The ground truth for dimensional accuracy would likely be the original CAD model or physical measurement of the source object. No human experts are explicitly mentioned for establishing this ground truth, rather the comparison is against the "original model".
Diagnostic Qualitative Evaluation: "Maxillofacial surgeons" were interviewed. Their specific qualifications (e.g., years of experience, subspecialty) are not provided beyond being maxillofacial surgeons. The number of surgeons is not specified.
Fidelity Validation of detectable anatomical landmarks: The ground truth would be the known anatomical landmarks on the "educational anatomic models." No experts are explicitly mentioned for establishing this ground truth, as it is inherent to the models.

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

No specific adjudication method is mentioned for any of the studies. For qualitative evaluations, it sounds like individual surgeon opinions were aggregated, but no formal adjudication process (like consensus reading or tie-breaking) is described.

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 MRMC comparative effectiveness study is mentioned. The qualitative evaluation focused on the perceived utility of the models as a "significant help" to surgeons, rather than quantifying improvement in human reader performance with or without the device. The device itself is described as a "pre-operative planning tool" and "diagnostic models" to be used "in conjunction with other diagnostic tools and expert clinical judgment," implying it's an aid, not a standalone diagnostic tool or an AI for image interpretation.

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

The studies described are primarily focused on the physical and qualitative aspects of the generated models. The device's function involves human input (processing DICOM by "commercial off-the-shelf software" and subsequent human interaction for planning) and the output (digital or physical models) is for a human surgeon to use in conjunction with their judgment. Therefore, a standalone algorithm-only performance study in the sense of a purely interpretative AI is not applicable or described. The "Fidelity Validation" and "Dimensional Validation" assess the accuracy of the output product (models) in replicating anatomical features, which is a form of standalone performance for the manufacturing process, but not for diagnostic interpretation by an AI.

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

Dimensional Validation: Original digital model or measured physical dimensions.
Diagnostic Qualitative Evaluation: Clinical experience and qualitative assessment by maxillofacial surgeons.
Fidelity Validation of detectable anatomical landmarks: Known anatomical landmarks on educational models.
No mention of pathology or outcomes data being used for ground truth.

8. The sample size for the training set:

The document describes the device as processing "DICOM imaging information" through "commercial off-the-shelf software" (Mimics Medical, K183105) and then having "biomedical engineers" work with surgeons for planning. It also states that the "anatomic models are created by TechFit versus the end user" and that they use "the same segmentation/3D reconstruction software to create 3D anatomic models Mimics Medical (K183105)."
This suggests that the core segmentation and 3D reconstruction is performed by a previously cleared software (Mimics Medical). The "TECHFIT Diagnostic Models" appear to be the output of a service that utilizes this software, along with human expertise, to create patient-specific models.
Therefore, there isn't a "training set" for the "TECHFIT Diagnostic Models" in the typical AI/ML sense, as the core algorithms for image processing and segmentation likely belong to the COTS software (Mimics Medical) and would have their own validation. The TECHFIT process leverages this and human expertise.

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

As elaborated in point 8, a dedicated training set for "TECHFIT Diagnostic Models" is not described as it is not a de novo AI/ML algorithm being trained by TECHFIT. The ground truth establishment for the underlying COTS software (Mimics Medical) would be relevant here, but is not detailed in this document.

Summary

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TECHFIT Digital Surgery, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K222577

January 6, 2023

Trade/Device Name: TECHFIT Diagnostic Models Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: November 1, 2022 Received: November 2, 2022

Dear Prithul Bom:

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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological ImagingDevices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222577

Device Name TECHFIT Diagnostic Models

Indications for Use (Describe)

The TECHFIT Diagnostic Models are patient-specific devices intended to be used as a pre-operative planning tool for treatment in the field of maxillofacial surgery.

The physical replica can be used for diagnostic purposes in the field of, maxillofacial applications.

TECHFIT Diagnostic Models should be used in conjunction with other diagnostic tools and expert clinical judgment.

TECHFIT Diagnostic Models are not intended to enter the operating room

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Techfit. The logo consists of a blue sphere with a smaller, gray, crescent-shaped object partially overlapping it. Below the sphere, the word "TECHFIT" is written in a simple, sans-serif font, with each letter in uppercase.

510(k) Summary K222577

21 CFR 807.92 2050

Submitter information:

Submitter	TECHFIT Digital Surgery Inc.1511 Aviation Center PkwySuite 220HDaytona Beach, FL 32114
Contact person	David García-PatiñoRegulatory Affairs SpecialistPhone: +57 604 322-33-75 Ext. 165david.garcia@techfit.com.co
Date prepared	January 6, 2023

Subject device information:

Trade name	TECHFIT Diagnostic Models
Common or Usual name	Medical image management and processing system
Classification name	System, Image Processing, Radiological
Product code (classification regulation)	LLZ
Regulation number	892.2050

Predicate device information:

Trade name	Materialise N.V.
510(k) number	K183105
Common or Usual name	Mimics Medical
Classification name	System, Image Processing, Radiological
Product code (classification regulation)	LLZ
Regulation number	892.2050

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Device description

TECHFIT Diagnostic Models are virtual and additive manufactured anatomic models intended for diagnostic use during maxillofacial surgery planning.

TECHFIT Diagnostic Models are intended for single use only.

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The TECHFIT Diagnostic Models are patient-specific devices intended to be used as a pre-operative planning tool for treatment in the field of maxillofacial surgery.

The input data file (DICOM imaging information from a medical scanner file) is processed by commercial off-the-shelf Indications for Use software, and the result is an output data file that may then be provided as digital models or used as input to produce physical anatomic models using additive manufacturing.

The physical replica can be used for diagnostic purposes in field of, of, maxillofacial the the the

TECHFIT Diagnostic Models should be used in conjunction with other diagnostic tools and expert clinical judgment.

TECHFIT Diagnostic Models are not intended to enter the operating room

Device design and manufacturing

Starting from a patient's CT scan and dentition data (optional), a virtual model of the patient's anatomy is generated. Prior to the surgery, a biomedical engineer works along with the surgeon to define a pre-operative surgical plan based on virtual 3D models of the patient's anatomy.

Based on the pre-operative plan, models are designed using medical CAD software. After the surgeon approves the pre-operative plan and device designs, the diagnostic models are produced through an additive manufacturing process

Technological Characteristics & Substantial Equivalence Discussion

The intended use of the subject device, TECHFIT Diagnostic Models, is the same as the predicate device, Mimics Medical (K183105). The design process for both the subject and the predicate device starts from a patient's CT scan, taken according to a specific CT scan protocol.

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Similarities to predicate

The subject and the predicate device have the same intended use, the anatomic models are produced from the patient's CT scan and we use the same segmentation/3D reconstruction software to create 3D anatomic models Mimics Medical (K183105).

Differences from predicate

The differences between the subject and predicate device are that the anatomic models are created by TechFit versus the end user.

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A device comparison table of the subject and predicate device is provided in Table 1.

Characteristic	Subject device:TECHFITDiagnosticmodels	Mimics Medical K183105
Classification	21 CFR 892.2050	21 CFR 892.2050
Class	Class II.	Class II.
Product code	LLZ	LLZ
Indications for Use	The TECHFIT DiagnosticModels are patient-specificdevices intended to be usedas a pre-operative planningtool for treatment in the fieldof maxillofacial surgery.The input data file (DICOMimaging information from amedical scanner file) isprocessed by commercial off-the-shelf software, and theresult is an output data filethat may then be provided asdigital models or used asinput to produce physicalanatomic models usingadditive manufacturing.The physical replica can beused for diagnostic purposesin the field of, maxillofacialapplications.TECHFIT Diagnostic Modelsshould be used inconjunction with otherdiagnostic tools and expertclinical judgment.TECHFIT Diagnostic Modelsare not intended to enter theoperating room.	Mimics Medical is intended foruse as a software interface andimage segmentation system forthe transfer of medical imaginginformation to an output file.Mimics Medical is also intendedfor measuring and treatmentplanning.The Mimics Medical output canbe used for the fabrication ofphysical replicas of the outputfile using traditional or additivemanufacturing methods. Thephysical replica can be used fordiagnostic purposes in the fieldof orthopedic, maxillofacial andcardiovascular applications.Mimics Medical should be usedin conjunction with expertclinical judgement.
Material(s)	Clear resin	Multiple
Manufacturer	TECHFIT Digital Surgery	Materialise N.V.

Table 1. Substantial Equivalence Comparison.

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HardwareTechnologies	3D Printing to producephysical output devices	3D Printing to produce physicaloutput devices
Proprietary planningsoftware	No, we use Mimics Medical(K183105)	Yes
Patient-specificconfiguration?	Yes	Yes
CT Scan	Yes	Yes
PhysicianInteraction	Yes	Yes

Non-clinical Performance Data

A table with the summary of the performance data was provided in Table 2

Test Performed	Description	Results
3D Printing processvalidation	A manufacturing processcharacterization wasperformed to validate thatthe manufacturing processcan correctly print theTECHFIT DiagnosticModels.The process validationstrategy included theInstallation Qualification(IQ), OperationalQualification (OQ), andPerformance Qualification(PQ).	The acceptance criteriawere met
Dimensional Validation	The 3D printed deviceswere manufactured andscanned with CT scan. The3D printed devicesconsisted of multipleanatomic models fromdifferent patients (mandiblesand maxilla) as the worst-case to evaluate theaccuracy.The original model and	All the measurementscomplied with theacceptance criterion
	scanned model weredigitally aligned andoverlapped. Then, thedimensional error wasestimated by comparing thedifference between theoverlapped images on apoint-by-point basis.
Packaging Validation	The packaging system wassubjected to simulatedshipment following theStandard Practice forPerformance Testing ofShipping Containers andSystems (ASTM D4169-16),and environmentalconditioning as per ISTA3A.	The acceptance criteriawere met
Diagnostic QualitativeEvaluation	A clinician review report wasperformed with the intentionto evaluate thediagnostically significance ofTECHFIT DiagnosticModels (TDMs) according tothe clinical experience ofmaxillofacial surgeons	The interviewed surgeonsdeemed TECHFITDiagnostic models asignificant help when itcomes to identifyingdifferent pathologies andplan a more precise surgicalintervention when used inconjunction of otherdiagnostic tools.
Fidelity Validation ofdetectable anatomicallandmarks	A test was performed tovalidate the device'sreplicability of anatomicallandmarks from educationalanatomic models andmaintain dimensionalaccuracy	All selected landmarks inthe educational anatomicmodel were identified in thevirtual models and the 3Dprinted models

Table 2 Summary of data performance

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Substantial Equivalence Conclusion

Based on the indications for use, technological characteristic, and comparison to subject/predicate devices, the TECHFIT Diagnostic Models show to be substantially equivalent to the predicate device.

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).