The NuVasive Lateral Plate System is indicated for use as an adjunct to fusion 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.

Device Description

The NuVasive Lateral Plate System consists of a variety of plates and screws. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a Medical Device (NuVasive Lateral Plate System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing for mechanical components. It does not typically involve the kinds of clinical studies or AI algorithm evaluations that would generate acceptance criteria and performance data as requested in the prompt.

Therefore, most of the requested information regarding acceptance criteria for device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set details for AI algorithms is not applicable to this specific document.

The document states:

"Summary of Clinical Tests (Not Applicable)." This explicitly states no clinical tests were performed.
"All mechanical testing performed in full compliance with ASTM F1717 was presented." This indicates the primary method of demonstrating performance was through mechanical testing against a standard.

Given this, I cannot provide the requested information from the provided text for most of the points.

Here's what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The device was tested in "full compliance with ASTM F1717". This ASTM standard would define the acceptance criteria for mechanical performance (e.g., fatigue strength, static strength) for spinal implant assemblies. However, the specific values of these criteria and the reported device performance against them are not provided in this summary document. The summary only states that the testing was performed in compliance.
Reported Device Performance: Not detailed in the provided summary.

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 device underwent mechanical testing, not clinical data collection. Therefore, there is no "test set" in the context of clinical or AI performance evaluation. The term "sample size" would refer to the number of devices tested mechanically, which is not specified.

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. Ground truth, in the context of expert consensus, is relevant for clinical or AI studies. This device underwent mechanical testing.

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

Not Applicable. No clinical or AI test set requiring adjudication was used.

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

Not Applicable. This is not an AI device, and no clinical comparative effectiveness study was performed.

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

Not Applicable. This is not an AI device.

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

Not Applicable. The "ground truth" for mechanical testing is compliance with a specific industry standard (ASTM F1717).

8. The sample size for the training set

Not Applicable. This is not an AI device, so there is no training set.

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

Not Applicable. This is not an AI device, so there is no training set or associated ground truth establishment process.

Summary

{0}------------------------------------------------

Special 510(k) Premarket Notification Lateral Plate System

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.

Ms. Han Fan Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3338 Fax: (858) 909-3438 Email: hfan@nuvasive.com

MAY - 8 2009

B. Device Name

NuVasive Lateral Plate System Trade or Proprietary Name: Common or Usual Name: Spinal Implants Spinal Intervertebral Body Fixation Orthosis Classification Name: Device Class: Class II Classification: 888.3060 Product Code: K WQ

C. Predicate Devices

Predicate Device:	NuVasive Lateral Plate System, NuVasive Lateral Plate System, NuVasive Lateral Plate System, and NuVasive Anterior Lumbar Plate System
510(k) Number:	K070273, K061789, K082070, and K072339
Date of Concurrence:	April 3, 2008, August 10, 2006, September 24, 2008, and October 19, 2007

D. Device Description

The NuVasive Lateral Plate System consists of a variety of plates and screws. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.

{1}------------------------------------------------

Intended Use E.

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.

All mechanical testing performed in full compliance with ASTM F1717 was presented.

H. Summary of Clinical Tests (Not Applicable).

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAY - 8 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NuVasive Inc. % Ms. Han Fan Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California

Re: K091071

Trade/Device Name: NuVasive Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 9, 2009 Received: April 16, 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 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.

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.

{3}------------------------------------------------

Page 2- Ms. Han Fan

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

David Krone for

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

Enclosure

{4}------------------------------------------------

510(k) Number (if known): K091071

Device Name: NuVasive Lateral Plate System

Indications For Use:

The NuVasive Lateral Plate System is indicated for use as an adjunct to fusion 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), turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scollosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Prescription Use (Part 21 CFR 801 Subpart D)

510(k) Numbe

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)

Page 1 of 1

G. Hi for. MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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.