The NuVasive Lateral Plate System is indicated for use via the 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 Lateral Plate System consists of a variety of plates, screws, bolts, and Implant components can be rigidly locked to suit the individual locking nuts. pathology and anatomical conditions of the patient.

AI/ML Overview

This document (K061789) is a 510(k) Premarket Notification for the NuVasive Lateral Plate System.

Based on the provided text, a conventional acceptance criteria and study that proves the device meets specific performance metrics, as one might find for software or diagnostic devices, was not conducted and is not present in this document. This document instead follows the regulatory pathway for medical devices seeking substantial equivalence to already legally marketed predicate devices.

Here's an breakdown of why the requested information isn't available and what was done instead:

Explanation of Absence of Requested Information for K061789

The provided document is a 510(k) Premarket Notification, which is a regulatory submission to the FDA. For devices seeking clearance via the 510(k) pathway, the primary goal is to demonstrate "substantial equivalence" to a predicate device already on the market. This typically involves comparing device features, intended use, materials, and technological characteristics, and often includes non-clinical performance testing (e.g., mechanical testing). It generally does not require de-novo clinical studies with acceptance criteria based on performance metrics like sensitivity, specificity, or reader improvement.

Specifically, the document states:

"H. Summary of Clinical Tests (Not Applicable)." (Page 1) This explicitly indicates that no clinical trials were performed to demonstrate performance in humans for this submission.
"Data was provided which demonstrated the NuVasive Lateral Plate to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function." (Page 1) This is the core of a 510(k) submission.

Therefore, the following requested sections cannot be filled from the provided text:

A table of acceptance criteria and the reported device performance: Not applicable; no such criteria or performance reporting for clinical metrics are present.
Sample sized used for the test set and the data provenance: Not applicable; no clinical test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical test set requiring expert ground truth was used.
Adjudication method: Not applicable; no clinical test set requiring adjudication was used.
Multi reader multi case (MRMC) comparative effectiveness study: Not applicable; no clinical study was performed.
Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable; this device is a physical implant, not an algorithm.
The type of ground truth used: Not applicable; no clinical ground truth was established for performance metrics.
The sample size for the training set: Not applicable; this device is a physical implant, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable; this device is a physical implant, not an AI/ML algorithm requiring a training set.

What Was Done Instead (Based on the Document):

The substantial equivalence was demonstrated through:

Comparison of Indications for Use: The NuVasive Lateral Plate System has indications for use that are considered equivalent to predicate devices for spinal instability due to various conditions (fracture, tumor, degenerative disc disease, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous surgery) in thoracic, thoracolumbar, lumbar, and lumbosacral regions.
Design, Material, and Function Equivalence: The document states that "substantial equivalence is based upon equivalence in indications for use, design, material, and function." This implies that the design of the plates, screws, bolts, and locking nuts, the materials used for these components, and how they function (e.g., interlocking mechanisms, stability) were demonstrated to be similar enough to predicate devices.
Non-Clinical Tests: "Mechanical testing was presented." This is the primary form of 'testing' mentioned for physical implants in a 510(k). This testing would typically assess aspects like fatigue strength, pull-out strength, bending stiffness, and torsional rigidity to ensure the device can withstand physiological loads and perform its intended mechanical function safely, similar to predicate devices. The specific acceptance criteria and results of these mechanical tests are not detailed in this summary document but would have been part of the full 510(k) submission.

In summary, this document is a regulatory clearance letter and summary for a physical medical device. It relies on demonstrating substantial equivalence and mechanical testing, not clinical studies with performance acceptance criteria as typically seen for diagnostics or AI/ML devices.

Summary

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K061789 (pg 1 of 2)
510(k) Premarket Notification
Lateral Plate System

AUG 1 0 2006

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

Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121 Telephone: (858) 909-1868 Fax: (858) 909-2068

B. Device Name

Trade or Proprietary Name: NuVasive Lateral Plate System Common or Usual Name: Spinal Implants Classification Name: Spinal Intervertebral Body Fixation orthosis. Device Class: Class II Classification: $888.3060 Product Code: KWO

C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared devices.

D. Device Description

E. Intended Use

The NuVasive Lateral Plate System is indicated for use via the 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 lumborsacral (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.

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NUVASIVE

510(k) Premarket Notification
Lateral Plate System

F. Substantial Equivalence

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

G. Summary of Non-Clinical Tests Mechanical testing was presented.
Kob 1789
H. Summary of Clinical Tests (Not Applicable).

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2006

NuVasive, Inc. c/o Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance 4545 Towne Center Court San Diego, CA 92121

Re: K061789

Trade Name: NuVasive Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: K WQ Dated: June 23, 2006 Received: June 26, 2006

Dear Ms. Cousin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Laetitia Cousin

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Barbara Buelno

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

Enclosure

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4. INDICATIONS FOR USE

510(k) Number (if known):

Device Name: NuVasive Lateral Late System

Indications for Use:

The NuVasive Lateral 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.

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)

	Barbara Buchholz for pam
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(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K061789
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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.