Ricoh 3D Anatomic Models are intended as physical replicas of patient anatomy to be used for diagnostic purposes in the fields of craniomaxillofacial and orthopedic applications. The Anatomic Models are based on DICOM imaging information from a medical scanner and output files from FDA cleared software intended for the creation and output of digital files suitable for the fabrication of physical replicas. The models should be used in conjunction with other diagnostic tools and expert clinical judgement.

Device Description

The subject device, each "Ricoh 3D Anatomic Model," is a patient-specific physical replica of an anatomic structure or site, produced via additive manufacturing from a user generated 3D print file. The input 3D print file is created from medical images in DICOM format that have been seqmented to a specific reqion of interest within an FDA cleared application, IBM iConnect Access (K203104). The input 3D print file is then transferred to Ricoh for production and delivery of the physical replica.

AI/ML Overview

The provided text describes a 510(k) summary for the Ricoh 3D Anatomic Models device. The device is a patient-specific physical replica of an anatomic structure, produced via additive manufacturing from a user-generated 3D print file. It is intended for diagnostic purposes in craniomaxillofacial and orthopedic applications.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The core performance validation for the Ricoh 3D Anatomic Models focuses on the geometric accuracy of the physical replicas compared to the input digital 3D file.

Acceptance Criteria	Reported Device Performance
Geometric accuracy of physical replicas	Physical models can be printed accurately at less than 1mm mean deviation when compared against the input digital 3D file. All clinically relevant acceptance criteria were met.
Packaging protects product from damage	Testing showed that the packaging adequately protects the product from damage throughout the distribution process.

Study Details

The provided text offers limited, high-level details regarding the study methodologies.

1. Sample Size Used for the Test Set and Data Provenance:

The text states "geometric accuracy of printed orthopedic and craniomaxillofacial physical models was assessed via bench testing." It does not specify the exact sample size (i.e., number of models, number of measurements per model) used for this test set.
The data provenance is implied to be prospective bench testing performed by Ricoh, rather than based on patient data from specific countries. The input digital 3D files are derived from patient DICOM imaging information, but the "test set" for accuracy assessment refers to the physical models themselves.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The text does not specify the number of experts or their qualifications involved in establishing the ground truth measurements for the geometric accuracy testing of the physical models. The "ground truth" here is the original digital 3D file, and the comparison is a technical measurement, not a subjective expert assessment of the model's diagnostic utility directly.
The indication for use states that "The models should be used in conjunction with other diagnostic tools and expert clinical judgement," implying that clinical experts would ultimately use and evaluate the models in practice, but this is not part of the described technical validation study.

3. Adjudication Method for the Test Set:

The text does not describe an adjudication method as it relates to human review of the test set, as the primary assessment is a quantitative comparison of the physical model to the digital file. This is a technical measurement validation rather than an image reading study.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done or described. This type of study typically involves human readers (e.g., radiologists) evaluating medical images or outputs with and without AI assistance to measure diagnostic performance. The Ricoh 3D Anatomic Models are physical replicas, and the validation described focuses on their physical accuracy, not on human diagnostic performance using the models in a comparative MRMC setup.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Yes, a standalone performance assessment was done in the sense that the geometric accuracy of the fabricated physical models was assessed against the digital input file. This is a direct measurement of the device's output (the physical model) against its intended technical specification (replicating the digital design), without human interpretation of diagnostic value as the primary endpoint of this specific performance test.

6. The Type of Ground Truth Used:

The ground truth for the geometric accuracy testing was the input digital 3D file. The physical model was compared against this digital representation.

7. The Sample Size for the Training Set:

The Ricoh 3D Anatomic Models device does not appear to be an AI/ML algorithm that requires a "training set" in the conventional sense. It is a manufacturing process (additive manufacturing) that takes a digital file and produces a physical object. Therefore, a training set size is not applicable to the description of this device's validation. The device's performance relies on the precision of the manufacturing process and materials.

8. How the Ground Truth for the Training Set was Established:

As noted above, this question is not applicable as the device description does not involve an AI/ML training set. The "ground truth" for the overall process originates from patient DICOM images that are segmented using FDA-cleared software (e.g., IBM iConnect Access), which then generates the 3D print file. The validation described here is of the physical printing process itself, not the image segmentation or diagnosis preceding the 3D print file generation.

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 text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

Ricoh USA, Inc. % Mr. Scott Brewer Sr. Manager, Regulatory Compliance, Additive Manufacturing 5575 Venture Drive Unit A PARMA OH 44130

Re: K220205

June 3, 2022

Trade/Device Name: Ricoh 3D Anatomic Models Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 2, 2022 Received: May 3, 2022

Dear Mr. Brewer:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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.

For

Thalia T. Mills, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220205

Device Name Ricoh 3D Anatomical Models

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

-SUBMITTER

Ricoh USA, Inc. 5575 Venture Drive Unit A Parma, Ohio | USA | 44130 Tel: +1.954.648.5680 Email: Gary.Turner@RicohUSA.com

Contact Person:	Scott Brewer
Date Prepared:	May 31, 2022

DEVICE .

Name of Device: Ricoh 3D Anatomic Models Classification Name: Radiological Image Processing System Regulation: 21 CFR §892.2050 Requlatory Class: Class II Product Classification Code: LLZ

= PREDICATE & REFERENCE DEVICES

Predicate Manufacturer:	Materialise NV
Predicate Trade Name:	Mimics inPrint
Predicate 510(k):	K173619

DEVICE DESCRIPTION IV.

V. INDICATIONS FOR USE

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

	Anatomic Models	Mimics inPrint K173619	Comments on SE
Trade Name	Anatomic Models, Ricoh3D	Mimics inPrint, Materialise	-
Common Name	Image processing system	Image processing system	Same
Classification Name	System, Imageprocessing, Radiological	System, Imageprocessing, Radiological	Same
Classification	LLZ	LLZ	Same
Product Code	892.2050	892.2050	Same
Indications for Use	Ricoh 3D AnatomicModels are intended asphysical replicas of patientanatomy to be used fordiagnostic purposes in thefields of craniomaxillofacialand orthopedicapplications. TheAnatomic Models arebased on DICOM imaginginformation from a medicalscanner and output filesfrom FDA cleared softwareintended for the creationand output of digital filessuitable for the fabricationof physical replicas. Themodels should be used inconjunction with otherdiagnostic tools and expertclinical judgement.	Mimics inPrint is intendedfor use as a softwareinterface and imagesegmentation system forthe transfer of DICOMimaging information from amedical scanner to anoutput file. It is also used aspre-operative software fortreatment planning. For thispurpose, the Mimics inPrintoutput file can be used forthe fabrication of physicalreplicas of the output fileusing traditional or additivemanufacturing methods.The physical replica can beused for diagnosticpurposes in the field oforthopedic, maxillofacialand cardiovascularapplications. Mimics inPrintshould be used inconjunction with otherdiagnostic tools and expertclinical judgement.	The indications foruse of the subjectdevice are a subsetof the predicatedevice.The subject devicedoes not providediagnostic imagesegmentation or thetransfer of medicalimaging informationto an output file.Instead, the deviceutilizes output filesfrom a cleared ClassII medical device.The subject deviceincludes a subset ofanatomical regions,including onlycraniomaxillofacialand orthopedicapplications.
Design (keycomponents/features)	The Ricoh 3D AnatomicalModels are produced froma 3D print file. The 3D printfile is imported from aClass II medical device,IBM iConnect Access,which allows for advancedimage segmentation andediting tools for thepurpose of creating digital3D anatomical models.Once the 3D print file isimported, the surgicalteam, radiological team	Mimics inPrint is imageprocessing software thatallows the user to import,visualize and segmentmedical images, check andcorrect the segmentations,and create digital 3Dmodels. The models can beused in Mimics inPrint formeasuring, treatmentplanning and producing anoutput file to be used foradditive manufacturing (3Dprinting). Mimics inPrint is	The subject devicedesign is a subset ofthe predicate device.The subject deviceutilizes an imported3D print file fordesign andfabrication of thephysical replica.
	Anatomic Models	Mimics inPrint K173619	Comments on SE
	(segmentation team) andRicoh production teamcan:• Communicate aboutproject needs/scope,establish/track projecttimelines,• Approve final STL file forfabricationUnder the direction of theclinical user, the RicohBiomedical Engineeringteam will generate aprintable anatomic model.Once final approval of themodel is achieved from theclinical user, theanatomical model will beprinted, post-processed,and undergo a qualityvalidation process. Afterinspection and approval,the anatomical model islabeled and distributed tothe customer.	structured as a modularpackage. This includes thefollowing functionality:• Importing medicalimages in DICOM formatand other formats (suchas BMP, TIFF, JPG andraw images)• Viewing images andDICOM data• Selecting a region ofinterest using genericsegmentation tools• Segmenting specificanatomy using dedicatedsemi-automatic tools orfully automaticalgorithms• Verifying and editing aregion of interest• Calculating a digital 3Dmodel and editing themodel• Planning treatments(surgical cuts etc.) on the3D modelsThe output digital 3D modelis suitable for production ofa physical model usingcompatible 3D printers andmaterials.
Performance Testing	• Geometric accuracy ofthe physical replicas	• Software measurementaccuracy and calculate3D study• Geometric Accuracy ofphysical replicas.	The subject deviceincludes a subset ofthe testing of thepredicate device, andonly includesgeometric accuracytesting of physicalreplicas.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Validation Testing

Validation testing included assessment of the workflow from input digital 3D file to output physical replica. Similar to the predicate device, the geometric accuracy of printed orthopedic and craniomaxillofacial physical models was assessed via bench testing. Testing showed that the physical models can be printed accurately at less than 1mm mean deviation when compared against the input digital 3D file, and all clinically relevant acceptance criteria was met.

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Shipping Validation

Simulated distribution and handling testing was performed to assess the packaging for Ricoh 3D Anatomic Models. Testing showed that the packaging adequately protects the product from damage throughout the distribution process.

VIII. CONCLUSIONS

A comparison of intended use and technological characteristics combined with performance data demonstrates that Ricoh 3D Anatomical Model is 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).