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, templates, 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 provided text describes a 510(k) summary for the VSP® Orthopedics System, which is a device for surgical planning and guiding. However, the document does not contain specific information regarding acceptance criteria for device performance studies, nor does it detail a study that proves the device meets specific performance acceptance criteria.

Instead, the document focuses on:

Regulatory classification and intended use.
Comparison to a predicate device, highlighting that the new device is "substantially equivalent" with only differences in a new material (SLA printing resin Accura ClearVue for anatomical models).
Verification and validation testing related to manufacturing processes, cleaning, sterilization, biocompatibility, and shelf life of the components of the system, rather than a clinical performance study measuring an output metric against an acceptance criterion.

The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." This means a clinical performance study, often involving human readers or direct measurement of an output against a functional criterion, was not performed or deemed necessary for this 510(k) submission.

Therefore, I cannot provide the requested table or answer the specific questions about performance studies, sample sizes, ground truth establishment, or MRMC studies, as this information is not present in the provided text.

The closest information found pertains to general testing conducted:

Summary of Testing Mentioned (not device performance acceptance criteria):

Testing Type	Acceptance Criteria (General Statement)	Reported Performance (General Statement)
Operational Qualification	All test method acceptance criteria met	Manufacturing process assessed over the range of allowable process parameters; all criteria met.
Performance Qualification	All test method acceptance criteria met	Manufacturing process repeatability assessed at nominal parameters; all criteria met.
Cleaning Validation	All test method acceptance criteria met	Following soiling and cleaning of the subject device, bioburden, protein levels, and hemoglobin levels were examined; all criteria met.
Sterilization Validation	All test method acceptance criteria met	Steam sterilization validations performed in accordance with ISO 17665-1:2006 to a sterility assurance level (SAL) of 10-6; all criteria met.
Biocompatibility Validation	Pre-defined acceptance criteria met	Sensitization, irritation, and acute systemic toxicity testing conducted on Accura ClearVue were within pre-defined acceptance criteria.
Shelf Life Validation	Maintain functionality	Accura ClearVue anatomical model outputs maintain functionality following a shelf life of 3 months.
Clinical Performance Data	N/A	Clinical testing was not necessary for the determination of substantial equivalence.

Regarding the specific questions:

A table of acceptance criteria and the reported device performance: See table above, but note these are for manufacturing/material V&V, not device performance in terms of accuracy or clinical utility.
Sample sizes used for the test set and the data provenance: Not specified for device performance. Sample sizes for validation tests (e.g., biocompatibility batch sizes, number of sterilization cycles) are not detailed. Data provenance is implied to be internal testing by 3D Systems.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such performance study is described. The device involves "physician input" and review, but this is part of its design and workflow, not a ground truth establishment for a performance study.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "Clinical testing was not necessary."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a system involving physical and digital outputs, and intended for use "to assist in preoperative planning and/or in guiding..." indicating a human-in-the-loop product. No standalone algorithmic performance is described.
The type of ground truth used: Not applicable, as no performance study requiring ground truth is described.
The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the conventional sense. It's a surgical planning and guiding system.
How the ground truth for the training set was established: Not applicable.

Summary

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November 10, 2021

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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

3D Systems Ben Johnson Vice President, Portfolio & Regulatory, Healthcare 5381 South Alkire Circle Littleton, Colorado 80127

Re: K211244

Trade/Device Name: VSP Orthopedics 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: October 12, 2021 Received: October 14, 2021

Dear Ben Johnson:

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.

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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 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.

For

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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)

K211244

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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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:	Scott BrewerDirector, Regulatory Affairs, Healthcare
Date Prepared:	April 23, 2021
DEVICE
Trade Name:	VSP® Orthopedics System
Common Name:	Patient specific orthopedic anatomical models, templates, guides, andsurgical plans.
Classification Name:	Orthopaedic Surgical Planning and Instrument Guides
Classification:	Class II, 21 CFR 888.3030
Product Code:	PBF

4. PREDICATE DEVICES

Predicate device:

VSP® Orthopedics System, 3D Systems (K190044)

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.

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

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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.

6. INTENDED USE

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® Orthopedics System), differing only in the expansion of materials included within the VSP® Orthopedics System for anatomic models. The potential impact on substantial equivalence of each technological difference was addressed by risk analysis and verification and validation testing.

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 comprise both digital and physical outputs which can include patientspecific anatomical models, and guides for the purpose of assisting the surgeon during maxillofacial surgeries. The subject device and the predicate device are both intended to be generated by trained personnel, in a non-medical manufacturing or office environment, with active support from the surgeon. The subject device uses the same technologies as the predicate device. These include image transfer and manipulation via software that is subsequently used for 3D printing of anatomical models and guides 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 produced by the subject device. The subject device serves the same patient population as the predicate device.

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 anatomical 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.

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The following testing was conducted for the VSP® Orthopedics 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 it's intended use.
Shelf Life Validation A shelf life validation was performed to ensure Accura ClearVue anatomical model outputs maintain functionality following a shelf life of 3 months.
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® Orthopedics 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.

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.