The NuVasive ACP4 System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

WARNING: The NuVasive ACP4 System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Description

The NuVasive ACP4 System consists of a variety of plates, screws, and screw-retaining covers designed to provide stabilization as an adjunct to cervical fusion.

AI/ML Overview

The provided document is a 510(k) Summary for the NuVasive ACP4 System, a cervical plate and screw system. This document focuses on demonstrating the substantial equivalence of the device to a predicate device through mechanical testing and comparison of indications for use. It explicitly states that clinical tests are "Not Applicable."

Therefore, based on the provided document, the following information regarding acceptance criteria and a study proving the device meets those criteria is not available or not relevant to the type of submission:

Table of acceptance criteria and the reported device performance: Not available. This document pertains to mechanical testing (summary only) and equivalence to a predicate device. Performance criteria for clinical use with specific metrics (e.g., sensitivity, specificity, accuracy) are not included.
Sample size used for the test set and the data provenance: Not applicable as no clinical study with a test set is described. The document mentions "Mechanical testing was presented," but details of this testing (sample sizes, specific methods, results) are not provided in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study with a test set is described.
Adjudication method for the test set: Not applicable as no clinical study with a test set is described.
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: Not applicable. This device is a surgical implant, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical study with a test set is described.
The sample size for the training set: Not applicable as no AI/algorithm training is described for this device.
How the ground truth for the training set was established: Not applicable as no AI/algorithm training is described for this device.

Summary of what is available from the document:

Device Type: Cervical plate and screw system for anterior screw fixation of the cervical spine.
Study Type: The submission relies on mechanical testing (details not provided in this summary) and a comparison of indications for use to a predicate device (SmartPlate Gradient Plus System by NuVasive) to demonstrate substantial equivalence.
Clinical Tests: Explicitly stated as "(Not Applicable)" in section H.

Therefore, the provided document does not contain the specific information requested about acceptance criteria and clinical study performance in the context of an AI/diagnostic device. It is a 510(k) summary for a physical medical device (implant) where substantial equivalence is typically established through non-clinical (e.g., mechanical) testing and comparison of design and indications to a legally marketed predicate.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the word "NUVASIVE" in all caps. Below the word "NUVASIVE" is the text "Creative Spine Technology" in a smaller font. The logo is simple and modern, and the text is clear and easy to read.

VII. 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular $807.92, the following summary of information is provided:

Submitted by: A.

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

JAN 1 8 2007

B. Device Name

Trade or Proprietary Name:	NuVasive ACP4 System
Common or Usual Name:	Cervical Plate and Screw System
Classification Name:	Spinal Intervertebral Body Fixation Orthosis
Device Class:	Class II
Classification:	§888.3060
Product Code:	KWQ

C. Predicate Devices

The subject ACP4System is substantially equivalent to the SmartPlate Gradient Plus System currently distributed commercially in the U.S. by NuVasive.

D. Device Description

The NuVasive ACP4 System consists of a variety of plates, screws, and screw-retaining covers designed to provide stabilization as an adjunct to cervical fusion.

E. Intended Use

WARNING: The NuVasive ACP4 System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

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Y062590 Page 2 of 2

Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized "N" symbol to the left of the word "NUVASIVE" in bold, sans-serif font. Below the word "NUVASIVE" is the tagline "Creative Spine Technology" in a smaller, italicized font.

Comparison to Predicate Devices F.

The subject device has indications for use identical to those of its predicate, and employs the same principles of operation.

Summary of Non-Clinical Tests G.

Mechanical testing was presented.

Summary of Clinical Tests H.

(Not Applicable).

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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 its wings spread, and three human figures underneath the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NuVasive, Incorporated c/o Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance 4545 Towne Centre Court San Diego, California 92121

JAN 1 8 2007

Re: K062590

Trade/Device Name: NuVasive ACP4 System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 09, 2006 Received: October 10, 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.

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Page 2 - Ms. Laetitia Cousin

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 forth in the quality systems (OS) 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,

Barbara Bush

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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Indications for Use

K062590 510(k) Number (if known):

Device Name: ACP4 Anterior Cervical Plating System

Indications For Use:

WARNING: The NuVasive ACP4 System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Prescription Use (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 Buchner for NKN
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K062590

Regulation Number and Section

N/A