The NuVasive® VersaTie™ System is a temporary implant for use in orthopedic surgery. The System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

Spinal trauma surgery, used in sublaminar or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium alloy whenever "wiring" may help secure the attachment of other implants.

Device Description

The NuVasive VersaTie System is part of a spinal fixation system designed to provide an interface between spinal anatomy and a rod used in spinal surgery. The device is secured around posterior vertebral structures such as the lamina, facet, transverse processes, and spinous process from T1-L5. The system is comprised of braided bands and clamps designed to attach to titanium alloy or cobalt-chromium alloy rods. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to introduce an additional surgical technique.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the NuVasive® VersaTie™ System, a temporary implant for use in orthopedic surgery. The document focuses on establishing substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study design for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not found within this particular document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It generally states that the device was shown to be "substantially equivalent" to its predicate based on the nonclinical testing.

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Implied: Mechanical performance (strength, durability, pull-through resistance) equivalent to predicate device.	"The results demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate."

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

The document mentions "nonclinical testing" was performed, which typically refers to mechanical or bench testing. It does not refer to a "test set" in the context of patient data or clinical studies. Therefore, information about sample size for a test set (in terms of patient data) or data provenance (country of origin, retrospective/prospective) is not applicable as this was not a clinical study involving human subjects or patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes nonclinical (bench) testing, not a study involving human data or expert review for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes nonclinical (bench) testing, not a study involving human data or requiring adjudication.

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

This information is not applicable. The device is a physical bone fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical bone fixation system, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the nonclinical testing, the "ground truth" would be the engineering specifications and established mechanical properties of the predicate device. The performance of the subject device (NuVasive® VersaTie™ System) was compared against these established characteristics of the predicate to demonstrate substantial equivalence. This is not "expert consensus, pathology, or outcomes data" in the typical clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. The document describes nonclinical (bench) testing of a physical device, and does not involve a training set as would be relevant for machine learning or AI models.

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

This information is not applicable for the same reasons as point 8.

Summary of Study (Based on Provided Text):

The study described is a nonclinical performance study comparing the NuVasive® VersaTie™ System to a legally marketed predicate device (NuVasive VersaTie System cleared in K161265). The purpose was to demonstrate substantial equivalence for the new device.

The testing performed included:

Static and dynamic Anterior-Posterior band pull-through testing
Static and dynamic Caudal-Cranial band pull-through testing

Conclusion from the document: The results of this nonclinical testing demonstrated that the subject NuVasive® VersaTie™ System is substantially equivalent to the predicate. The "acceptance criteria" were implied to be performance characteristics (e.g., strength, durability, pull-through resistance) comparable to or better than the predicate device.

Summary

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December 7, 2017

NuVasive, Inc. Ms. Olga Lewis Senior Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K173117

Trade/Device Name: NuVasive® VersaTie™ System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: December 4, 2017 Received: December 6, 2017

Dear Ms. Lewis:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173117

Device Name NuVasive® VersaTie™ System

Indications for Use (Describe)

The indications for use include the following applications:

Spinal trauma surgery, used in sublaminar or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium alloy whenever "wiring" may help secure the attachment of other implants.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

A. Submitted by:

Olga Lewis Senior Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800

Date Prepared: December 4, 2017

B. Device Name

Trade or Proprietary Name:	NuVasive® VersaTie™ System
Common or Usual Name:	Bone Fixation Cerclage, Sublaminar
Classification Name:	Bone Fixation Cerclage
Device Class:	Class II
Classification:	21 CFR § 888.3010
Product Code:	OWI

C. Predicate Devices

The subject device is substantially equivalent to the primary predicate device NuVasive VersaTie System cleared in K161265.

D. Device Description

E. Intended Use

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
1. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis;
1. Spinal degenerative surgery, as an adjunct to spinal fusions.

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Image /page/4/Picture/0 description: The image shows the Nuvasive company logo. The logo consists of a stylized leaf shape in purple and gray, followed by the company name "NUVASIVE" in gray. The logo is simple and modern, and the colors are muted and professional.

The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobalt-chromium alloy whenever "wiring" may help secure the attachment of other implants.

F. Technological Characteristics

As was established in this submission, the subject NuVasive VersaTie System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.

Performance Data G.

Nonclinical testing was performed to demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate device. The following testing was performed:

Static and dynamic Anterior-Posterior band pull-through testing ●
Static and dynamic Caudal-Cranial band pull-through testing

The results demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate.

H. Conclusions

The subject NuVasive VersaTie System has been shown to be substantially equivalent to a legally marketed predicate devices for its intended use.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.