The NuVasive Brigade Anterior 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) I-Sl) 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 Brigade Anterior Plate System is an anterior/anterolateral, thoracolumbar system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, and Nitinol SE508 alloy conforming to ASTM F2063.

AI/ML Overview

The provided document describes a 510(k) summary for the NuVasive® Brigade® Anterior Plate System, a spinal implant. The focus of the summary is to demonstrate substantial equivalence to previously cleared predicate devices through performance testing. This type of regulatory submission for a medical device does not involve a study to "prove the device meets acceptance criteria" in the way one would for an AI/CADe device.

Instead, the "acceptance criteria" here refer to demonstrating that the new device performs at least as well as, or better than, the predicate devices in specific mechanical tests, thereby proving substantial equivalence. There is no AI component, and thus no need for human expert review, ground truth establishment, or MRMC studies.

Here's an analysis based on the provided text, adapted to the questions where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a mechanical device like a spinal implant, "acceptance criteria" are typically defined by recognized standards (e.g., ASTM) and internal design specifications. The performance is measured against these standards or compared directly to predicate devices.

Acceptance Criterion	Reported Device Performance
Static Compression per ASTM F1717	The subject Brigade Anterior Plate System meets or exceeds the performance of the predicate device.
Dynamic Compression per ASTM F1717	The subject Brigade Anterior Plate System meets or exceeds the performance of the predicate device.
Static Torsion per ASTM F1717	The subject Brigade Anterior Plate System meets or exceeds the performance of the predicate device.
Material Composition Conformance	Manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, and Nitinol SE508 alloy conforming to ASTM F2063.
Intended Use Equivalence	Substantially equivalent to predicate devices for the stated indications.
Technological Characteristics Equivalence	Substantially equivalent to predicate devices in design, function, and range of sizes.

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

Sample Size: The document does not specify the exact number of physical samples (implants) used for each mechanical test. This level of detail is typically found in the full test reports, not the 510(k) summary.
Data Provenance: The tests are explicitly stated as "Nonclinical testing" conducted to demonstrate performance. This implies laboratory testing on physical samples of the device, rather than data from human subjects or clinical settings, and therefore does not have a "country of origin" for data in the typical sense, nor is it retrospective or prospective clinical data.

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

Not Applicable. This is a mechanical device test, not an AI/CADe device or a study involving human interpretation of medical images. "Ground truth" in this context refers to the measured physical properties and performance against established engineering standards (ASTM F1717). No human experts are used to "establish ground truth" in the way they would for a diagnostic study.

4. Adjudication Method for the Test Set

Not Applicable. As this is a mechanical test rather than a clinical or diagnostic study, there is no need for an adjudication method. The results are quantitative measurements against defined standards.

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

No, an MRMC study was not done. This is a mechanical device with no AI component or human-in-the-loop interaction for diagnostic purposes.

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

No, this is not an AI/algorithm-based device. Therefore, no standalone algorithm performance testing was conducted.

7. The Type of Ground Truth Used

Engineering Standards and Specifications: The "ground truth" for this device's performance is based on established engineering test standards (specifically ASTM F1717 for static and dynamic compression and static torsion) and the material specifications (ASTM F136, ISO 5832-3, ASTM F2063). Performance is then compared against that of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not Applicable. This is a mechanical device, not a machine learning model. There is no concept of a "training set."

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

Not Applicable. As there is no training set, this question is not relevant.

In summary, the provided document describes a 510(k) submission for a traditional mechanical spinal implant. It focuses on demonstrating substantial equivalence to predicate devices through well-established nonclinical (laboratory) mechanical testing, rather than clinical studies or the development and validation of an AI/CADe system.

Summary

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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:

Cynthia Adams Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (858) 320-4549

JUL 16 2012

Date Prepared: June 21, 2012

B. Device Name

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

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

C. Predicate Devices

The subject NuVasive Brigade Anterior Plate System is substantially equivalent to the following devices:

KI11866 NuVasive, Inc. Halo® II Anterior Lumbar Plate System .
. K072339 - NuVasive Anterior Lumbar Plate System

D. Device Description

E. Intended Use

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Special 510(k) Premarket Notification Brigade® Anterior Plate System

F. Technological Characteristics

JUVASIV

As was established in this submission, the subject Brigade Anterior 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 Brigade Anterior 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 Brigade Anterior 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 Brigade Anterior 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a stylized caduceus symbol. The text is arranged in a circular pattern around the symbol. The symbol is a stylized representation of a staff with a snake winding around it.

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

NuVasive, Incorporated % Ms. Cynthia Adams Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121

JUL 16 2012

Re: K121837

Trade/Device Name: NuVasive® Brigade® Anterior Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 21, 2012 Received: June 22, 2012

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-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.

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Page 2 - Ms. Cynthia Adams

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 yours,

Eunice Keith

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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

The NuVasive Brigade Anterior 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-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K121837 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.