The VSP® Orthopedics System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the distal femur, tibia, and non-sacrum pelvis.

Device Description

The VSP® Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures. The system contains several physical and digital outputs including patient-specific anatomical models, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs).

Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution.

The VSP® Orthopedics System also contains Stainless Steel Drill Inserts (VSP® Orthopedics System Accessories) which are intended to be used by the physician to guide drilling activities during the surgical procedure. The inserts fit into a standard hole in the cutting / drill guides and can be used across all VSP® Orthopedics System guides and templates.

AI/ML Overview

The VSP® Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of numerical acceptance criteria or reported device performance metrics like sensitivity, specificity, or accuracy for the overall system. Instead, it states that:

"All design, process, and other 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."

This indicates that the acceptance criteria were qualitative and focused on demonstrated compliance with pre-established specifications and substantial equivalence to the predicate device.

The "Performance Testing" section lists the types of tests performed:

Test Type	Description
Equipment Qualification	IQ/OQ/PQ
Process Qualification	PQ
Mechanical Testing	Detailed results not provided in the summary
Software Validation	Detailed results not provided in the summary
Cleaning Validation	Detailed results not provided in the summary
Sterilization Validation	Detailed results not provided in the summary
Biocompatibility Validation	Detailed results not provided in the summary
Packaging Validation	Detailed results not provided in the summary
Shelf Life Validation	Detailed results not provided in the summary
Drop Test Validation	Detailed results not provided in the summary
Debris Validation	Detailed results not provided in the summary
Cadaver Study	Performed to prove the device performs according to its intended use

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

The document specifies "Bench and cadaveric testing was conducted" and includes "Cadaver Study" as a test type. However, it does not provide any details on the sample size (number of cadavers or specific test scenarios) used for the cadaver study or any other test set.

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective).

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

The document states: "Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution." While this indicates physician involvement in the design and review process, it does not specify the number of experts used to establish ground truth for a test set or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size for human readers improving with AI assistance. The system is described as a "surgical instrument to assist in pre-operative planning and/or in guiding..." which implies human-in-the-loop, but no comparative study to measure assistance effectiveness is detailed in this summary.

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

The document does not explicitly state if a standalone (algorithm only) performance study was conducted. The description of the system's outputs ("patient-specific anatomical models, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs)") suggests that the system generates these outputs, which are then reviewed by a physician.

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

The document implies that the ground truth for the system's performance, particularly in the cadaver study, would be based on direct observation of surgical guidance and accuracy against the pre-operative plan. Since the system assists in planning and guiding, the "ground truth" would likely be the surgical outcome or accuracy of instrument placement as verified in the cadaveric setting. However, the exact nature of this "ground truth" and how it was established is not detailed. It mentions "physician input" and "reviewed by the physician," suggesting expert judgment forms a basis, but not explicitly as a ground truth for a test set.

8. The sample size for the training set

The document does not provide any information regarding a training set or its sample size. This summary focuses on verification and validation testing, not the development or training of an AI component, if one exists within the system's planning features.

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

Since no information on a training set is provided, there is also no information on how its ground truth was established.

Summary

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August 21, 2019

Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

3D Systems, Inc. Kim Torluemke Vice President, Quality & Regulatory 5381 South Alkire Circle Littleton, Colorado 80127

Re: K190044

Trade/Device Name: VSP® Orthopedics System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PBF Dated: July 23, 2019 Received: July 24, 2019

Dear Kim Torluemke:

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 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,

For, Shumaya Ali, MPH Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic 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) K190044

Device Name VSP® Orthopedics 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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Medical Modeling™

510(K) SUMMARY

1. Introduction

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

2. SUBMITTER

Name:	3D Systems, Inc.
Address:	5381 South Alkire CircleLittleton, CO 80127, USAPhone: (720) 643-1001Fax: (720) 643-1009
Official Contact:	Kim TorluemkeVice President, Quality and Regulatory, Healthcare
Date Prepared:	July 23, 2019
DEVICE
Trade Name:	VSP® Orthopedics System
Common Name:	Patient specific orthopedic anatomical models, templates, guides, and surgicalplans.
Classification Name:	Orthopaedic Surgical Planning and Instrument Guides
Classification:	Class II, 21 CFR 888.3030
Product Code:	PBF
PREDICATE DEVICES

Predicate device:

· SurgiCase Orthopaedics System, Materialise N.V. (K163156)
Reference devices:
VSP® System, 3D Systems Inc. (K120956, K133907)
VSP® Cranial System, 3D Systems Inc. (K151285)

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Medical Modeling™

5. DESCRIPTION OF THE DEVICE

Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution.

6. INDICATIONS FOR USE

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The intended use and technological characteristics of the subject device (VSP® Orthopedics System) are either identical or substantially equivalent to the predicate device (Surgicase Orthopaedics System), differing only in the expansion of anatomical regions included within the VSP® Orthopedics System. The potential impact on substantial equivalence of each technological difference was addressed by risk analysis and verification and validation testing.

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. Bench and cadaveric 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® Orthopedics System:

· Equipment Qualification (IQ/OQ/PQ)
· Process Qualification (PQ)
· Mechanical Testing
Software Validation
· Cleaning Validation
Sterilization Validation

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Image /page/5/Picture/1 description: The image shows the 3D Systems logo. On the left is a 3D cube-like shape with the number 3 on its side. To the right of the shape is the company name "3D SYSTEMS" in a sans-serif font. The logo is clean and modern, with a focus on the company's name and its association with 3D technology.

Medical Modeling™

Biocompatibility Validation
Packaging Validation
Shelf Life Validation
Drop Test Validation
Debris Validation
· Cadaver Study

Summary

All design, process, and other 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

Based on a comparison of the intended use and technological characteristics, the VSP® Orthopedics System is substantially equivalent to the identified predicate device. Minor differences in the indications for use, technological and performance characteristics do not raise new or different questions of safety and effectiveness. Additionally, the non-clinical testing supports that the system performs in accordance with its intended use and is as safe, as effective, and performs as well as the predicate device.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.