The NuVasive Halo II Anterior Lumbar Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Device Description

The NuVasive Halo II Anterior Lumbar Plate System consists of a series of plates and screws manufactured from Ti-6Al-4V per ASTM F-136 and ISO 5832-3. The plates also include components manufactured from Nitinol alloy SE508 per ASTM F2063.

AI/ML Overview

Here's an analysis of the provided text regarding the NuVasive Halo II Anterior Lumbar Plate System, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Requirements)	Reported Device Performance
Material Composition	Manufactured from Ti-6Al-4V per ASTM F-136 and ISO 5832-3. Plates include components manufactured from Nitinol alloy SE508 per ASTM F2063.
Design	Substantially equivalent to predicate devices (K072339 NuVasive, Inc. Anterior Lumbar Plate System, K052546 Depuy Spine AEGIS Anterior Lumbar Plate System) in design and technological characteristics.
Intended Use	Substantially equivalent to predicate devices in intended use. Indicated for use via lateral or anterolateral surgical approach (T1-L5) or anterior surgical approach (L1-S1) for various spinal instabilities.
Mechanical Performance (Strength/Durability)	Meets or exceeds the performance of the predicate device. Demonstrated through nonclinical testing: Static and dynamic compression testing per ASTM F1717, and Static torsion testing per ASTM F1717.
Biocompatibility	Implied to be acceptable as materials (Ti-6Al-4V, Nitinol) are standard for implants and the device is deemed "safe and effective." (No specific biocompatibility test results are detailed in the summary).

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

Sample Size: Not explicitly stated. The document refers to "nonclinical testing" but does not specify the number of devices or components tested.
Data Provenance: The studies are "nonclinical testing," meaning they are laboratory-based tests, not human or animal studies. The data is internal to the manufacturer (NuVasive, Inc.). It is retrospective in the sense that the tests were conducted prior to the 510(k) submission, but it's not clinical data.
Country of Origin: United States (NuVasive, Inc. is based in San Diego, California).

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

Number of Experts: Not applicable in the context of this device. The "ground truth" for this type of device (spinal implant) is established through engineering and material standards, and benchmark testing against predicate devices. The "experts" are the engineers and scientists who conducted and interpreted the mechanical and material tests, aligning with established ASTM and ISO standards.
Qualifications of Experts: Not specified. However, by adhering to ASTM and ISO standards, it's implied that the personnel involved possess the necessary engineering and technical expertise.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. For mechanical performance testing of an implant, there isn't typically an "adjudication" process like there would be for image interpretation. The results are quantitative measurements compared against predefined engineering standards and predicate device performance benchmarks. The determination of whether the device "meets or exceeds" these standards is based on direct measurement and statistical analysis (though the specific statistical methods are not detailed).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No.
Effect size of human readers with vs. without AI assistance: Not applicable. This device is a physical spinal implant, not an AI-assisted diagnostic or decision-support system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? Not applicable. This device is a physical spinal implant, not an algorithm. The "standalone" performance here relates to its mechanical integrity and material properties, which were tested in a standalone manner (without a human implanting it into a patient during the test).

7. Type of Ground Truth Used

Ground Truth: The ground truth for this device is primarily based on:
- Engineering Standards: Established ASTM (F1717) and ISO (5832-3, F2063) standards for material properties and mechanical performance for spinal implants.
- Predicate Device Performance: The demonstrated performance of legally marketed, substantially equivalent predicate devices (K072339 and K052546). The Halo II system needed to meet or exceed these established benchmarks.

8. Sample Size for the Training Set

Sample Size: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

How Ground Truth was Established: Not applicable, as there is no training set for this device.

Summary

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K111866

Image /page/0/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized eye-like shape on the left and the word "NUVASIVE" on the right. Below the word "NUVASIVE" is the phrase "speed of innovation" in a smaller font.

510(k) Premarket Notification Halo II Anterior Lumbar Plate System

510(k) Summary

2 2 2011 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:

Sheila Bruschi Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (858) 320-4515

Date Prepared: July 20, 2011

B. Device Name

Trade or Proprietary Name:	NuVasive Halo II Anterior Lumbar Plate System
Common or Usual Name:	Anterior, Noncervical Spinal Implant
Classification Name:	Spinal Intervertebral Body Fixation Orthosis

Device Class:	Class II
Classification:	21 CRF §888.3060
Product Code:	KWQ

C. Predicate Devices

The subject NuVasive Halo II Anterior Lumbar Plute System is substantially equivalent to the following devices:

· K072339 NuVasive, Inc. Anterior Lumbar Plate System
· K052546 Depuy Spine AEGIS Anterior Lumbar Plate System

D. Device Description

E. Intended Use

The NuVasive Halo II Anterior Lumbar Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L) .-SI) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

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K11866

Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized letter "N" on the left, followed by the word "NUVASIVE" in all caps. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font. The logo is simple and modern, and the tagline emphasizes the company's focus on innovation.

510(k) Premarket Notification Halo II Anterior Lumbar Plate System

Technological Characteristics F.

As was established in this submission, the subject Halo II Anterior Lumbar Plate 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 the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject Halo II Anterior Lumbar Plate System is substantially equivalent to other predicate devices. The following testing was performed:

. Static and dynamic compression testing per ASTM F1717
. Static torsion testing per ASTM F1717

The results of these studies show that the subject Halo II Anterior Lumbar Plate System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Halo II Anterior Lumbar Plate System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

NuVasive, Inc. % Ms. Sheila Bruschi Associate Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

JULL 2 22 22 2013

Re: K111866

Trade/Device Name: NuVasive Halo II Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 28, 2011 Received: June 30, 2011

Dear Ms. Bruschi:

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

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Page 2 - Ms. Sheila Bruschi

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely vours.

Kru Dothin Lirir

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

Enclosure

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Indications for Use

510(k) Number (if known): KI | | 866

Device Name:

Indications For Use:

The NuVasive Halo II Anterior Lumbar Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division/Sign-O :)

Division of Surgi - 1. Orthopedic, and Restorative Levices

KIII866 510(k) Number_

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.