The NuVasive HELIX ACP 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 HELIX ACP 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 HELIX ACP System consists of a variety of plates and screws designed to provide stabilization as an adjunct to cervical fusion.

AI/ML Overview

This document describes the NuVasive HELIX ACP System, a cervical plate and screw system. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study that proves the device meets them based on the provided input.

Here's a breakdown of why I cannot answer each point from the input:

A table of acceptance criteria and the reported device performance: Not provided in the text.
Sample sized used for the test set and the data provenance: Not provided in the text. The document mentions "Mechanical testing was presented" but doesn't detail the test set size or provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a clinical test set with ground truth is not described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as a clinical test set is not 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 is a medical device (spinal implant), not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (spinal implant), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as a clinical test set with ground truth is not described.
The sample size for the training set: Not applicable as this is not an AI/algorithm-based device requiring a training set.
How the ground truth for the training set was established: Not applicable as this is not an AI/algorithm-based device.

The document explicitly states under "H. Summary of Clinical Tests": "(Not Applicable)". This confirms that no clinical studies (which would typically involve ground truth, test sets, and performance criteria for a diagnostic/AI device) were part of this 510(k) submission for the NuVasive HELIX ACP System. The basis for clearance was "substantial equivalence" to a predicate device and mechanical testing (details of which are not provided here).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "NUVASIVE Creative Spine Technology". The logo features a stylized "N" with a curved line above it and a series of small circles within the letter. Below the main text, the words "Creative Spine Technology" are written in a smaller font.

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:

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

AUG - 8 2007

B. Device Name

Trade or Proprietary Name:	NuVasive HELIX ACP 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 HELIX ACP System is substantially equivalent to the Gradient Plus System currently distributed commercially in the U.S. by NuVasive.

D. Device Description

The NuVasive HELIX ACP System consists of a variety of plates and screws designed to provide stabilization as an adjunct to cervical fusion.

E. Intended Use

WARNING: The NuVasive HELIX ACP 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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Image /page/1/Picture/0 description: The image shows the logo for NUVASIVE, a medical device company. The logo features a stylized "N" with a curved line above it, followed by the word "NUVASIVE" in bold, sans-serif font. Below the company name 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.

G. Summary of Non-Clinical Tests

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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2007

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

Re: K071329

Trade/Device Name: NuVasive HELIX ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 20, 2007 Received: July 23, 2007

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. Ilsting 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Buehrig

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

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K071329
Page 1 of 1

Indications for Use

KOZI329 510(k) Number (if known):

Device Name: HELIX Anterior Cervical Plating System

Indications For Use:

The NuVasive HELIX Anterior Cervical Plating 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 HELIX Anterior Cervical Plating 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 Buellup for Mpd
Division Sign Off

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K071329

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.