Ricoh 3D Anatomic Models are intended as physical replicas of patient anatomy to be used for diagnostic purposes in the fields of craniomaxillofacial, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast 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 the acceptance criteria and the study that proves the device meets the
acceptance criteria in the context of a 510(k) premarket notification for a 3D Anatomic
Model.

Here's the breakdown of the information requested based on the
provided text:

1. Table of Acceptance Criteria and Reported Device

Performance

Acceptance Criteria	Reported Device Performance
Geometric accuracy of the physical replicas ("can be printed accurately at less than 1mm mean deviation when compared against the input digital 3D file")	Testing showed that the 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.	All clinically relevant acceptance criteria were met. (Specific criteria are not enumerated, but the broad statement
of meeting them is present.)
Packaging adequately protects the product from damage throughout the distribution process.	Testing showed that the packaging adequately protects the product from damage throughout the distribution process.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the specific
sample size used for the geometric accuracy testing (e.g., number of models
tested). It refers to "testing" and "assessment" but not quantitative sample
sizes.
Data Provenance: The document does not specify the country of origin of the data
or whether the study was retrospective or prospective. It describes "bench testing"
and "simulated distribution and handling testing," which are laboratory/controlled
tests rather than patient-data-driven clinical studies in the typical sense for an
AI/imaging device.

3. Number of Experts Used to Establish Ground Truth and

Qualifications

Not applicable. For this device (3D Anatomic Model), the "ground
truth" for geometric accuracy is the input digital 3D file (the design spec).
The product is a physical replica, and its accuracy is measured against the
digital file itself, not against a human expert's interpretation of a medical
image or a medical diagnosis. The document mentions "clinical user" approval of
the model, but this is part of the workflow and quality process, not the
ground truth establishment for performance testing.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the primary performance test
(geometric accuracy) compares the physical model directly to the digital input
file. There is no human interpretation or subjective assessment that would
require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness

Study was Done

No. The document makes no mention of an MRMC study. This type of
study is typically performed for AI-powered diagnostic software to assess its
impact on human reader performance. The device here is a physical replica
generated from an existing cleared software's output, not a diagnostic AI
algorithm.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop

Performance) Study was Done

Yes, in a way. The "Validation Testing" described, particularly the
geometric accuracy assessment, represents a standalone performance test of the
device's manufacturing capability to produce accurate physical models based on
digital input. It assesses the output of the manufacturing process (the
physical model) against its input (the digital file) without human
intervention being a variable in the measurement of geometric accuracy itself.

7. The Type of Ground Truth Used

The ground truth for the device's performance (geometric accuracy)
is the input digital 3D file from which the physical replica is printed.
The physical model is compared directly to this digital file using measurement
techniques to determine deviation.

For the purpose of the device's function (being a physical replica
for diagnostic purposes), the underlying "ground truth" of the patient's
anatomy would stem from the original DICOM imaging information, which is then
segmented by FDA cleared software to create the 3D print file. However, the
performance assessment of this specific device (the physical model itself)
uses the digital file as its reference.

8. The Sample Size for the Training Set

Not applicable. This device is a manufactured physical product (a 3D
print) based on a digital file, not an AI/machine learning algorithm that
requires a training set. The performance data relates to the manufacturing
accuracy and physical integrity of the printed models, not to an algorithm's
ability to learn from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.

Ricoh USA, Inc. % Scott Brewer Director, Regulatory Affairs and Quality, Additive Manufacturing 5575 Venture Drive, Unit A PARMA OH 44130

Re: K230119

May 2, 2023

Trade/Device Name: 3D Anatomic Model Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 28, 2023 Received: March 29, 2023

Dear Scott 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices 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)

K230119

Device Name 3D Anatomic Model

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: January 16, 2023

DEVICE =

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

= PREDICATE & REFERENCE DEVICES

Ricoh USA, Inc. Predicate Manufacturer: Predicate Trade Name: 3D Anatomic Models Predicate 510(k): K220205

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	Ricoh 3D Anatomic ModelsK220205	Comments on SE
Trade Name	Anatomic Models(Subject Device)	Anatomic Models	-
Common Name	Anatomic Models, Ricoh 3DImage processing system	Anatomic Models, Ricoh 3DImage processing system	Same
Classification Name	System, Image processing,Radiological	System, Imageprocessing, Radiological	Same
Classification	LLZ	LLZ	Same
Product Code	892.2050	892.2050	Same
Indications for Use	Ricoh 3D Anatomic Modelsare intended as physicalreplicas of patient anatomyto be used for diagnosticpurposes in the fields ofcraniomaxillofacial,orthopedic, cardiovascular,neurological,gastrointestinal,genitourinary, and breastapplications. The AnatomicModels are based onDICOM imaging informationfrom a medical scanner andoutput files from FDAcleared software intendedfor the creation and outputof digital files suitable forthe fabrication of physicalreplicas. The modelsshould be used inconjunction with otherdiagnostic tools and expertclinical judgement.	Ricoh 3D Anatomic Modelsare intended as physicalreplicas of patient anatomyto be used for diagnosticpurposes in the fields ofcraniomaxillofacial andorthopedic applications.The Anatomic 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.	The indications foruse of the subjectdevice expand thescope of anatomicregions from thoselisted for thepredicate device.Expandedapplications includecardiovascular,neurological,gastrointestinal,genitourinary, andbreast.
Design (keycomponents/features)	The Ricoh 3D AnatomicalModels are produced froma 3D print file. The 3D printfile is imported from a ClassII medical device, whichallows for advanced imagesegmentation and editingtools for the purpose ofcreating digital 3Danatomical models. Oncethe 3D print file is imported,the surgical team,radiological team(segmentation team) andRicoh production team can:• Communicate about	The Ricoh 3D AnatomicalModels are produced froma 3D print file. The 3D printfile is imported from a ClassII medical device, whichallows for advanced imagesegmentation and editingtools for the purpose ofcreating digital 3Danatomical models. Oncethe 3D print file is imported,the surgical team,radiological team(segmentation team) andRicoh production team can:• Communicate about	Same
	Anatomic Models(Subject Device)	Ricoh 3D Anatomic ModelsK220205	Comments on SE
	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, the anatomicalmodel will be printed, post-processed, and undergo aquality validation process.After inspection andapproval, the anatomicalmodel is labeled anddistributed to the customer.	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, the anatomicalmodel will be printed, post-processed, and undergo aquality validation process.After inspection andapproval, the anatomicalmodel is labeled anddistributed to the customer.
Performance Testing	• Geometric accuracy ofthe physical replicas	• Geometric accuracy ofthe physical replicas	Same

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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 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 were met.

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.

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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).