The NuVasive® Monolith 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 Monolith 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 material may be used at the surgeon's discretion.

Device Description

The Monolith Corpectomy System is a vertebral body replacement system manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The Monolith 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 Monolith Corpectomy System is provided non-sterile to be sterilized by the user before each use.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets them in the format requested.

The document is a 510(k) Premarket Notification for the NuVasive® Monolith Corpectomy System. It primarily focuses on demonstrating substantial equivalence to already marketed predicate devices.

Here's what the document does say regarding performance:

Performance Data: Nonclinical testing was performed to demonstrate substantial equivalence. The following tests were mentioned:
- Static Axial compression and torsion per ASTM F2077
- Push-out Analysis
- Subsidence Analysis
- MR Compatibility Analysis
Additional Analysis: Finite Elemental Analysis (FEA) and engineering rationale were provided.
Conclusion: The results of the testing and FEA demonstrate that the subject Monolith Corpectomy System is substantially equivalent to predicate devices.
Crucially: "No non-clinical or clinical studies were conducted."

Therefore, I cannot provide:

A table of acceptance criteria and reported device performance (specific numerical acceptance criteria are not detailed, nor are the specific numerical results of the tests).
Sample size for the test set or data provenance (as no clinical studies were performed).
Number of experts or their qualifications, or adjudication method (as no studies requiring expert review were performed).
Information on MRMC or standalone studies (as no clinical studies were performed).
Type of ground truth used (not applicable here, as it's a mechanical device tested against engineering standards, not diagnostic performance).
Sample size for the training set or how ground truth was established for it (not applicable here, as this is not an AI/machine learning device).

The document is about demonstrating the mechanical and material equivalence of a medical implant to existing devices through engineering tests, not about the performance characteristics of an AI or diagnostic device that would typically involve the criteria you've asked for.

Summary

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

March 30, 2017

NuVasive, Incorporated Cynthia Adams Specialist. Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K170271

Trade/Device Name: NuVasive® Monolith Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: January 26, 2017 Received: January 27, 2017

Dear Ms. Adams:

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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ResourcesforYou/Industry/default.htm. 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.

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,

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)

K170271

Device Name NuVasive® Monolith Corpectomy 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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Image /page/3/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf is split into two colors, purple and gray.

Traditional 510(k) Premarket Notification Nu Vasive® Monolith Corpectomy System

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:

Submitted by: Cynthia Adams Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: 858-320-4549

Date Prepared: January 26, 2017

B. Device Name

Trade or Proprietary Name:	NuVasive® Monolith 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 Monolith Corpectomy System is substantially equivalent to primary predicate device, NuVasive PEEK Corpectomy System (K151167), and additional predicate devices: NuVasive PEEK Corpectomy Railed System (K151538), NuVasive X-CORE Expandable VBR System (K142205), and reference device NuVasive Lumbar Interbody Implants (K161230).

D. Device Description

E. Indications For Use

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Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf is split into two colors, with the top half being a dark purple and the bottom half being a light gray.

Monolith 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 material may be used at the surgeon's discretion.

F. Technological Characteristics

The subject Monolith 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 Monolith Corpectomy System is substantially equivalent to other predicate devices. The following testing and analysis was performed:

Static Axial compression and torsion per ASTM F2077 ●
Push-out Analysis ●
Subsidence Analysis ●
MR Compatibility Analysis ●

Finite Elemental Analysis (FEA) and engineering rationale were also provided as evidence that the modified design of the Monolith Corpectomy System construct did not create a new worst case for performance testing. The results of the testing and Finite Elemental Analysis demonstrate that the subject Monolith Corpectomy System is substantially equivalent to predicate devices. No non-clinical or clinical studies were conducted.

H. Conclusions

Based on the indications for use, technological characteristics, mechanical testing, and comparison to predicate devices, the subject Monolith 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.