The Nuvasive® PEEK Corpectomy System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The PEEK Corpectomy System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft may be used at the surgeon's discretion.

Device Description

The NuVasive PEEK Corpectomy System is a vertebral body replacement system manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The PEEK Corpectomy System is made up of two primary components: a core and a set of endcaps. The core is offered in a variety of shapes and sizes to suit individual pathology and anatomical conditions of the patient. The modular endcaps are offered in multiple footprints and lordosis options. The device contains pins made of either titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 to serve as radiopaque markers. The System is provided non-sterile, and is designed to be sterilized by the user before each use.

AI/ML Overview

This document is a 510(k) summary for the NuVasive PEEK Corpectomy System, a device for spinal vertebral body replacement. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than providing detailed acceptance criteria and a study design for a diagnostic or AI device. Therefore, much of the requested information regarding acceptance criteria, study sample sizes (test and training sets), expert involvement for ground truth, adjudication methods, and MRMC studies is not applicable or available in this document.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

Key Takeaway: This submission relies on non-clinical mechanical testing to demonstrate substantial equivalence, not clinical performance data for a diagnostic device. As such, many of the requested elements related to diagnostic accuracy (like sensitivity, specificity, expert ground truth, etc.) are not applicable here.

Description of Acceptance Criteria and Proving Device Meets Them

This document does not describe acceptance criteria in the context of clinical performance or diagnostic accuracy (e.g., sensitivity, specificity, or agreement with ground truth established by experts). Instead, it demonstrates the device meets mechanical performance standards to show substantial equivalence to legally marketed predicate devices.

The "acceptance criteria" are implicitly the successful completion of the specified non-clinical tests, with results comparable to or better than predicate devices, thereby ensuring the device is safe and effective for its intended mechanical function within the body.

The study that proves the device meets these (mechanical) criteria is the set of non-clinical tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical device, not a diagnostic one, typical "acceptance criteria" like sensitivity/specificity are not applicable. The implicit acceptance criteria are successful completion of the following non-clinical tests and demonstrating comparable performance to predicate devices. The document does not provide specific numerical criteria or performance values from these tests, but states that the results "demonstrate that the subject PEEK Corpectomy System is substantially equivalent to predicate devices."

Acceptance Criteria (Implicit from Testing)	Reported Device Performance (Implicit from Study Conclusion)
Withstand static and dynamic axial compression per ASTM F2077	"The results demonstrate that the subject PEEK Corpectomy System is substantially equivalent to predicate devices." (Implies successful completion within acceptable limits)
Withstand static and dynamic torsion per ASTM F2077	"The results demonstrate that the subject PEEK Corpectomy System is substantially equivalent to predicate devices." (Implies successful completion within acceptable limits)
Maintain stability during push-out testing	"The results demonstrate that the subject PEEK Corpectomy System is substantially equivalent to predicate devices." (Implies successful completion within acceptable limits)
Exhibit acceptable subsidence characteristics based on analysis	"The results demonstrate that the subject PEEK Corpectomy System is substantially equivalent to predicate devices." (Implies successful completion within acceptable limits)

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

Sample Size for Test Set: Not specified in the document. For mechanical testing, this refers to the number of devices or constructs tested for each mechanical analysis (e.g., how many devices were subjected to axial compression). This information is typically found in the full test reports, not usually in the 510(k) summary.
Data Provenance: Not applicable in the context of human data. The "data" comes from in vitro mechanical testing performed on the device itself.
Retrospective or Prospective: Not applicable, as this refers to human data collection. Mechanical testing is a controlled experimental process.

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

Not applicable. Ground truth, in the context of expert review, refers to clinical or diagnostic accuracy. This document describes mechanical testing of a medical implant, where "ground truth" is determined by physical measurements and engineering standards, not expert clinical assessment.

4. Adjudication Method for the Test Set

Not applicable. Adjudication is relevant for expert disagreement in diagnostic or clinical assessment. For mechanical testing, results are quantitative and objective.

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

Not applicable. This is a medical implant, not an AI or diagnostic imaging device. No MRMC studies were performed. The document explicitly states: "No clinical studies were conducted."

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

Not applicable. This is a physical medical implant, not an algorithm or software. No standalone performance testing in this context was done.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering standards and mechanical test results. Specifically, the performance of the device relative to established ASTM (American Society for Testing and Materials) standards (F2077) and in comparison to predicate devices, is used to confirm its safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in this context.

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

Not applicable. As there's no training set for an AI model, there's no ground truth established for it.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 3, 2015

NuVasive, Incorporated Ms. Olga Lewis Lead Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K151167

Trade/Device Name: NuVasive® PEEK Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 4, 2015 Received: August 7, 2015

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Olga Lewis

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

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)

K151167

Device Name NuVasive® PEEK Corpectomy System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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 Lead Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3360

Date Prepared: August 4, 2015

B. Device Name

Trade or Proprietary Name:	NuVasive® PEEK Corpectomy System
Common or Usual Name:	Spinal Vertebral Body Replacement Device
Classification Name:	Spinal Intervertebral Body Fixation Orthosis

Device Class:	Class II
Classification:	21 CFR § 888.3060
Product Code:	MQP

C. Predicate Devices

The subject PEEK Corpectomy System is substantially equivalent to a primary predicate device, NuVasive Mesh (K032476), and additional predicate devices, NuVasive X-Core® Expandable VBR System (K142205), Osteotech VBR (K012254), Medtronic Verte-Stack® Spinal System (K070173) and Novel VBR Spinal System (K050553).

D. Device Description

The device contains pins made of either titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 to serve as radiopaque markers. The System is provided non-sterile, and is designed to be sterilized by the user before each use.

E. Indications For Use

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systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

F. Technological Characteristics

The subject PEEK Corpectomy 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 have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject PEEK Corpectomy System is substantially equivalent to other predicate devices. The following testing and analysis was performed:

Static and dynamic axial compression per ASTM F2077
Static and dynamic torsion per ASTM F2077 ●
Push-out testing ●
Subsidance analysis

The results demonstrate that the subject PEEK Corpectomy System is substantially equivalent to predicate devices. No clinical studies were conducted.

H. Conclusions

Based on the indications for use, technological characteristics, mechanical testing, and comparison to predicate devices, the subject PEEK Corpectomy System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.