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

Device Description

The NuVasive Laminoplasty Fixation System consists of different sizes of plates and screws that can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.

AI/ML Overview

The provided text is for a 510(k) Premarket Notification for the NuVasive Laminoplasty Fixation System. It describes a medical device for spinal surgery. The document is a regulatory submission, not a study report detailing acceptance criteria and performance data in the context of an AI-powered device or diagnostic tool.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment is not available in this document because it pertains to the regulatory clearance of a physical medical implant, not a software or AI-driven diagnostic device.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing or not applicable:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicit in text	Not explicit in text
Substantial Equivalence to predicate device	Demonstrated substantial equivalence in indications for use, design, material, and function to Synthes's Arch™ System (K032534).
Mechanical Testing standards met	Mechanical testing was presented (details not provided).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document discusses a physical medical device (implants) and its regulatory clearance, not a data-driven device or diagnostic tool that would typically involve test sets or data provenance in the context of performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This information is not relevant to the regulatory submission for this type of medical device. "Ground truth" in the context of data for a device performance study is not established for this product.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This information is not relevant to the regulatory submission for this type of medical device.

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 comparative effectiveness study was not done. This type of study is for evaluating observer performance with diagnostic tools, especially AI, which is not what this document is about. The document explicitly states "Summary of Clinical Tests (Not Applicable)".

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

No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. The concept of "ground truth" as it applies to performance evaluation of algorithms or diagnostic tests is not relevant to this medical device submission. The substantial equivalence was based on direct comparison to a predicate device and mechanical testing results.

8. The sample size for the training set

Not Applicable. There is no "training set" for this type of medical device.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, there is no corresponding ground truth to establish.

Summary

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K091623

Onuvasive

510(k) Premarket Notification Laminoplasty Fixation System

5. 510(K) SUMMARY

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

A. Submitted by

Ms. Han Fan Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Boulevard San Diego, California 92121 Telephone: (858) 909-3338 Fax: (858) 909-3438

OCT - 9 2009

B. Device Name

Trade or Proprietary Name:	NuVasive Laminoplasty Fixation System
Common or Usual Name:	Interlaminal Fixation Appliance
Classification Name:	Spinal Interlaminal Fixation Orthosis
Device Class:	Class II
Classification:	§888.3050
Product Code:	NQW

C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared device. Synthes's Arch™ System (K032534) that is currently distributed commercially in U.S.

D. Device Description

The NuVasive Laminoplasty Fixation System consists of different sizes of plates and screws that can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.

E. Intended Use

F. Substantial Equivalence

Data was provided which demonstrated the NuVasive Laminoplasty System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function.

G. Summary of Non-Clinical Tests

Mechanical testing was presented.

H. Summary of Clinical Tests (Not Applicable).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.

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

NuVasive, Incorporated % Ms. Han Fan Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121

Re: K091623

Trade/Device Name: NuVasive® Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: NOW Dated: September 25, 2009 Received: September 28, 2009

OCT - 9 2009

Dear Ms. Fan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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.

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. Han Fan

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 (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/defaulthtm.

Sincerely yours,

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

Enclosurc

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INDICATIONS FOR USE

510(k) Number (if known): K091623

Device Name: NuVasive® Laminoplasty Fixation System

Indications for Use:

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)

vice Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number /K09/623

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.