The NuVasive® Camber Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Camber Laminoplasty System is used to hold the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion, or impinging the spinal cord.

Device Description

The NuVasive® Camber Laminoplasty System consists of plates and screws of various sizes made from titanium alloy (ASTM F136) to provide reinforcement while expanding the spinal canal and preserving the posterior elements. Instruments required to implant the device are also available.

AI/ML Overview

This document describes the FDA 510(k) clearance for the NuVasive® Camber Laminoplasty System. This is a medical device, not an AI/ML imaging device, so the typical acceptance criteria and study designs for AI/ML devices (e.g., MRMC studies, standalone performance, ground truth establishment for AI training/testing data) are not applicable here.

Therefore, the response below will describe the device-specific acceptance criteria and the methods used to prove the device meets these criteria, based on the provided text, while explicitly stating that AI/ML specific criteria were not relevant for this device.

Acceptance Criteria and Study Proving Device Meets Criteria for NuVasive® Camber Laminoplasty System

The NuVasive® Camber Laminoplasty System is a spinal implant device cleared through the FDA's 510(k) pathway. The core acceptance criterion for this pathway is demonstration of substantial equivalence to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. For devices like this, performance is primarily assessed through non-clinical, bench-top mechanical testing rather than AI/ML specific performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Device Performance as Reported
Similar Intended Use: Intended for laminoplasty procedures in the lower cervical and upper thoracic spine (C3 to T3) to hold allograft/autograft material in place.	The NuVasive® Camber Laminoplasty System has the identical intended use as specified in the Indications for Use on page 2 and page 3. The predicate devices (NuVasive® Laminoplasty Fixation System & LeVerage LFS System, Medtronic Centerpiece Plate Fixation System) also share this intended use.
Similar Technological Characteristics: Consists of plates and screws made from titanium alloy (ASTM F136), designed to provide reinforcement while expanding the spinal canal and preserving posterior elements.	The device consists of plates and screws of various sizes made from titanium alloy (ASTM F136). The technological characteristics (design, material composition, function) were compared and deemed equivalent to predicate devices.
Performance (Non-Clinical/Bench Testing): Meet established mechanical performance standards relevant to spinal fixation devices to ensure comparable safety and effectiveness to predicates.	Non-clinical testing was performed, including: - Axial Pullout (per ASTM F2193) - Static 3-Point Bend - Dynamic 3-Point Bend The results demonstrate that the subject Camber Laminoplasty System meets the same criteria as the predicate devices.

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

Sample Size: Not specified as "sample size" in the context of human data or imaging data. For mechanical testing, the number of test specimens (e.g., number of plates/screws tested) would typically be defined by the test standard (e.g., ASTM F2193) and internal protocols. The document does not provide the specific number of units tested.
Data Provenance: The studies were non-clinical, bench-top tests performed by the manufacturer, NuVasive, Incorporated. The provenance is internal engineering lab testing. These tests are not retrospective or prospective in the sense of clinical studies.

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

This question is not applicable as the device is a mechanical implant, not an AI/ML imaging device. There were no "experts" establishing ground truth in the sense of image interpretation for AI. Device performance was assessed via engineering specifications and mechanical testing standards.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. Performance was measured objectively through mechanical tests (e.g., force, displacement), not through human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. This describes an AI/ML imaging device study. The NuVasive® Camber Laminoplasty System is a physical medical implant. No MRMC study was conducted.

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

This question is not applicable. This refers to AI/ML algorithm performance. The device is a mechanical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is defined by established mechanical engineering standards and criteria relevant to spinal implants (e.g., ASTM F2193, and criteria for static and dynamic bend tests). The device had to demonstrate it met these pre-defined engineering criteria, which are derived from the biomechanical requirements for such implants. There was no clinical outcomes data, pathology, or expert consensus used as "ground truth" in the way it's used for AI/ML diagnostic devices.

8. The Sample Size for the Training Set

This question is not applicable. There was no "training set" as this is not an AI/ML device.

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

This question is not applicable. There was no "training set."

Summary of Relevant Information from the Document:

Device Type: Spinal interlaminal fixation orthosis (mechanical implant).
Regulatory Pathway: 510(k) Premarket Notification.
Primary Evidence for Clearance: Demonstration of substantial equivalence through comparison of intended use, technological characteristics, and non-clinical performance data (mechanical testing) against legally marketed predicate devices.
Key Tests Conducted: Axial Pullout (per ASTM F2193), Static 3-Point Bend, Dynamic 3-Point Bend.
Conclusion: The device was found to be substantially equivalent to the predicate devices, meeting the necessary mechanical performance criteria. No clinical studies were required or conducted.

Summary

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July 3, 2019

NuVasive, Incorporated Thao Huynh Specialist. Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K191169

Trade/Device Name: NuVasive® Camber Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: April 30, 2019 Received: May 1, 2019

Dear Thao Huynh:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191169

Device Name NuVasive® Camber Laminoplasty System

Indications for Use (Describe)

The NuVasive® Camber Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Caminoplasty System is used to hold the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion, or impinging the spinal cord.

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/0 description: The image shows the logo for NuVasive. The logo consists of a stylized leaf shape in purple and gray on the left, followed by the word "NUVASIVE" in gray. The logo is simple and modern, and the colors are muted.

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 A.

Thao Huynh Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-5256

Date Prepared: July 2, 2019

B. Device Name

Trade Name:	NuVasive® Camber Laminoplasty System
Common Name:	Spinal Interlaminal Fixation Orthosis
Classification Name:	Orthosis, Spine, Plate, Laminoplasty, Metal
Regulation Number:	21 CFR § 888.3050
Product Code:	NQW

C. Predicate Devices

The subject NuVasive® Camber Laminoplasty System is substantially equivalent to the primary predicate device, NuVasive® Laminoplasty Fixation System & LeVerage LFS System (K1091623), and additional predicate Medronic Centerpiece Plate Fixation System (K050082). NuVasive® VuePoint® II OCT System (K180198) and NuVasive Affix II Spinous Process Plate System (K132411) are also used as reference predicates.

D. Device Description

E. Indications for Use

F. Technological Characteristics

As was established in this submission, the subject Camber Laminoplasty System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States.

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Image /page/4/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray on the left, followed by the word "NUVASIVE" in gray. The leaf shape is partially purple and partially gray, with the purple portion being on top. The word "NUVASIVE" is in a sans-serif font and is all uppercase.

The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate devices through comparison in areas including design, labeling/intended use, material composition, and function.

G. Performance Data

Non-clinical testing was performed to demonstrate that the subject Camber Laminoplasty System is substantially equivalent to other predicate devices. Engineering rationale and the following testing was performed:

. Axial Pullout (per ASTM F2193)
Static 3-Point Bend
Dynamic 3-Point Bend

The results demonstrate that the subject Camber Laminoplasty System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate. No clinical studies were conducted.

H. Conclusions

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

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.