The VSP® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the VSP® System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

Device Description

The VSP® System utilizes a combination of Commercial Off-The-Shelf (COTS) and custom software to manipulate 3D medical images (CT based systems) to create virtual and physical anatomical models, templates, surgical guides, and surgical plans for reconstructive surgical procedures.

AI/ML Overview

The provided text is a 510(k) Summary for the VSP® System and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a study with a test set, expert ground truth, and statistical analysis as would be done for an AI/ML-driven device.

The VSP® System is described as a software system and image segmentation system for maxillofacial surgery, which processes imaging information (CT-based) to create digital models, physical outputs (anatomical models, surgical guides), and aids in pre-operative simulation. The primary change in the current submission is the addition of a new material (Accura® ClearVue™) for anatomical models, not a change or new feature related to an AI/ML algorithm's diagnostic or predictive performance.

Therefore, the document does not contain the information required to answer the questions regarding acceptance criteria for an AI/ML device, such as performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, expert ground truth establishment, or MRMC studies. The "performance testing" described (Operational Qualification, Performance Qualification, Cleaning Validation, Sterilization Validation, Biocompatibility Validation) are related to manufacturing processes and material safety, not the diagnostic or prognostic performance of a software algorithm on a test dataset.

The only "performance testing" mentioned is:

Operational Qualification: Assessed manufacturing process over allowable parameters. All test method acceptance criteria were met.
Performance Qualification: Assessed manufacturing process repeatability at nominal parameters. All test method acceptance criteria were met.
Cleaning Validation: Performed in accordance with AAMI TIR 30. All test method acceptance criteria were met.
Sterilization Validation: Performed in accordance with ISO 17665-1:2006 to a SAL of 10^-6. All test method acceptance criteria were met.
Biocompatibility Validation: Evaluated in accordance with ISO 10993-1. Sensitization, irritation, and acute systemic toxicity testing conducted on the subject device manufactured from Accura ClearVue are within the pre-defined acceptance criteria.

The document explicitly states: "Clinical Performance Data - Clinical testing was not necessary for the determination of substantial equivalence." This further confirms that no study of the software's performance on a diagnostic/predictive task, using clinical data and ground truth, was performed or presented in this 510(k) summary.

In summary, based on the provided text, it is not possible to fill out the requested information as it pertains to an AI/ML driven device's performance study because such a study was not conducted or reported for this submission.

Summary

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April 26, 2021

3D Systems Scott Brewer Director, Regulatory Affairs, Healthcare 5381 South Alkire Circle Littleton, Colorado 80127

Re: K210347

Trade/Device Name: VSP® System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: February 5, 2021 Received: February 8, 2021

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

For Michael Adjodha 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) K210347

Device Name VSP® System

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 - K210347

1. INTRODUCTION

This document contains the 510(k) summary for the VSP® System. The content of this summary is based on the requirements of 21 CFR 807.92.

2. SUBMITTER

Name:	3D Systems
Address:	5381 South Alkire CircleLittleton, CO 80127, USAPhone: (720) 643-1001Fax: (720) 643-1009
Official Contact:	Scott BrewerDirector, Regulatory Affairs, Healthcare
Date Prepared:	April 23, 2021
DEVICE
Trade Name:	VSP® System
Common Name:	Patient specific maxillofacial anatomical models, templates, guides, andsurgical plans.
Classification Name:	Bone Cutting Instruments and Accessories
Classification:	21 CFR 872.4120
Class:	Class II
Product Code:	DZJ
Subsequent Product Code:	LLZ

4. PREDICATE DEVICES

Predicate device:

· VSP® System, Medical Modeling a 3D Systems Company (K192192)

5. DESCRIPTION OF THE DEVICE

6. INTENDED USE

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physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The intended use and technological characteristics of the subject device are either identical or substantially equivalent to the predicate device (VSP® System), differing only in the expansion of materials included within the VSP® System for anatomic models to include Accura® ClearVue™. The potential impact on substantial equivalence of each technological difference was addressed by risk analysis and verification and validation testing.

Specification /Characteristic	Subject Device, VSP® System, MedicalModeling a 3D Systems Company	Predicate Device, VSP® System,Medical Modeling Inc. (K192192)	Comparison
Classification	21 CFR 872.4120, 21 CFR 892.2050	21 CFR 872.4120, 21 CFR 892.2050	SubstantiallyEquivalent
Class	II	II	SubstantiallyEquivalent
Product Code	DZJ, LLZ	DZJ, LLZ	SubstantiallyEquivalent
Indications forUse	The VSP® System is intended for useas a software system and imagesegmentation system for the transferof imaging information from a medicalscanner such as a CT based system.The input data file is processed by theVSP® System and the result is anoutput data file that may then beprovided as digital models or used asinput to a rapid prototyping portion ofthe system that produces physicaloutputs including anatomical models,templates, and surgical guides for usein maxillofacial surgery. The VSP®System is also intended as a pre-operative software tool for simulating/ evaluating surgical treatmentoptions.	The VSP® System is intended for useas a software system and imagesegmentation system for the transferof imaging information from a medicalscanner such as a CT based system.The input data file is processed by theVSP® System and the result is anoutput data file that may then beprovided as digital models or used asinput to a rapid prototyping portion ofthe system that produces physicaloutputs including anatomical models,templates, and surgical guides for usein maxillofacial surgery. The VSP®System is also intended as a pre-operative software tool for simulating/ evaluating surgical treatmentoptions.	SubstantiallyEquivalent
TechnologicalDescription	Software / Hardware based devicethat incorporates image manipulationsoftware to transfer, segment andmodify images with input from thephysician that are further used tomanufacture, via rapid prototyping,anatomical models and surgicalguides. Additional system outputsinclude digital files and surgical caseplanning reports. Device includesimage processing software, hardwarefor rapid prototyping of physicaloutputs, and the resulting anatomicalmodels and surgical guides.	Software / Hardware based devicethat incorporates image manipulationsoftware to transfer, segment andmodify images with input from thephysician that are further used tomanufacture, via rapid prototyping,anatomical models and surgicalguides. Additional system outputsinclude digital files and surgical caseplanning reports. Device includesimage processing software, hardwarefor rapid prototyping of physicaloutputs, and the resulting anatomicalmodels and surgical guides.	SubstantiallyEquivalent
Specification /Characteristic	Subject Device, VSP® System, MedicalModeling a 3D Systems Company	Predicate Device, VSP® System,Medical Modeling Inc. (K192192)	Comparison
SoftwareTechnologies	Image transformation into 3D models,Computer Aided Design, Surgicalplanning / simulation	Image transformation into 3D models,Computer Aided Design, Surgicalplanning / simulation	SubstantiallyEquivalent
HardwareTechnologies	3D Printing to produce physical outputdevices	3D Printing to produce physical outputdevices	SubstantiallyEquivalent
System Inputs	DICOM file from Medical Scanner (CT,CBCT), patient contoured andstandard implant .STL files; input fromphysician	DICOM file from Medical Scanner (CT,CBCT), patient contoured andstandard implant .STL files; input fromphysician	SubstantiallyEquivalent
TechnologiesEmployed	Software, 3D Printing	Software, 3D Printing	SubstantiallyEquivalent
Materials	- Accura ClearVue Epoxy/ResinAcrylic (photopolymer):Stereolithography (SLA)- Accura SL 7810M Epoxy/Resin,Acrylic (photopolymer):Stereolithography (SLA)- Somos BioClear Epoxy/Resin,Acrylic (photopolymer):Stereolithography (SLA)- Accura Y-C 9300M Epoxy/Resin,Acrylic (photopolymer):Stereolithography (SLA)- Ti-6Al-4V: Direct Metal Printing- Polyamide: Selective LaserSintering	- Accura SL 7810M Epoxy/Resin,Acrylic (photopolymer):Stereolithography (SLA)- Somos BioClear Epoxy/Resin,Acrylic (photopolymer):Stereolithography (SLA)- Accura Y-C 9300M Epoxy/Resin,Acrylic (photopolymer):Stereolithography (SLA)- Ti-6Al-4V: Direct Metal Printing- Polyamide: Selective LaserSintering	SubstantiallyEquivalent
Method ofSterilization	Steam sterilization1 x 10-6 SAL	Steam sterilization1 x 10-6 SAL	SubstantiallyEquivalent
PhysicianInteractionwith Planningand PhysicianModel / GuideApproval	Yes	Yes	SubstantiallyEquivalent

Table 1: Substantial Equivalence Comparison

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Similarities to Predicate

The inputs to the subject device are identical to those of the predicate device. System outputs of the subject and predicate device are comprised of both digital outputs, which can include patient-specific anatomical models, guides, and splints for the purpose of assisting the surgeon during maxillofacial surgeries. The subject device and the predicate device are both intended to be used by trained personnel, in a non-medical manufacturing or office environment, with active support from the surgeon. The subject device uses the same fundamental technologies as the predicate device. These include image transfer and manipulation via software that is subsequently used for 3D printing of anatomical models, guides, and for surgical planning. The subject and predicate device use the same software components for the digital workflow. There has been no change to the sterilization process for the surgical guides and templates produced by the subject device. The subject device serves the same patient population as the predicate device.

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Differences to Predicate

One new material is presented in the modified system and makes up the changes presented within this Traditional 510(k) submission. The material, SLA printing resin Accura ClearVue, is being added to the system for anatomic models.

8. SUMMARY OF PERFORMANCE TESTING

The testing outlined below was intended to show that the output of the design and development process demonstrated compliance with the device specifications. Non-clinical testing was conducted to prove the subject device performs in accordance with its intended use and is substantially equivalent to the listed predicate device.

The following testing was conducted for the VSP System:

· Operational Qualification

A process operational qualification was performed to assess the manufacturing process over the range of allowable process parameters. All test method acceptance criteria were met.

• Performance Qualification

A process performance qualification was conducted to assess the manufacturing process repeatability at nominal parameters. All test method acceptance criteria were met.

· Cleaning Validation

A cleaning validation was performed in accordance with AAMI TIR 30. Following soiling and cleaning of the subject device, bioburden, protein levels, and hemoglobin levels were exampled. All test method acceptance criteria were met.

• Sterilization Validation

Steam sterilization validations were performed for the dynamic-air-removal cycle in accordance with ISO 17665-1:2006 to a sterility assurance level (SAL) of 10° using the biological indicator (BI) overkill method. All test method acceptance criteria were met.

• Biocompatibility Validation

Biocompatibility endpoints were evaluated in accordance with ISO 10993-1. Sensitization, irritation, and acute systemic toxicity testing conducted on the subject device manufactured from Accura ClearVue are within the pre-defined acceptance criteria. The results of the testing adequately address biocompatibility for the output device and its intended use.

• Clinical Performance Data

Clinical testing was not necessary for the determination of substantial equivalence.

All process and verification and validation testing, which were conducted as a result of risk analyses and design impact assessments, showed conformity to pre-established specifications and acceptance criteria. The acceptance criteria was established in support of device performance, and testing demonstrated substantial equivalence of the system to the predicate device.

9. CONCLUSION

The VSP System has the same intended use and similar technological characteristics as the predicate. Minor differences in the technological and performance characteristics do not raise new or different questions of safety and effectiveness. Therefore, the subject device is substantial equivalence to the predicate device.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

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