The Novel™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Novel™ VBR Spinal System is intended for use with supplemental spinal fixation systems. Specifically, the Novel™ VBR Spinal System is to be used with the Alphatec Zodiac™ Polyaxial Pedicle Screw System or the Alphatec Mirage™ Top Tightening Spinal System. Additionally, the Novel™ VBR Spinal System is intended for use with bone graft.

Device Description

The NOVEL™ VBR Spinal System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. System components are offered in three footprints of varying lengths, widths and heights to meet individual patient anatomy. System components are manufactured from titanium alloy (ASTM F136).

AI/ML Overview

The provided text is a 510(k) summary for the NOVEL™ VBR Spinal System, which is a vertebral body replacement device. This document describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the specific information required to answer your questions regarding acceptance criteria and a study proving device performance using AI/ML methodologies.

Here's a breakdown of why the information is missing and what it does provide:

No AI/ML Component: The NOVEL™ VBR Spinal System is a physical medical device (an implant). The 510(k) summary describes standard mechanical testing (Static and dynamic testing) for comparing its physical properties to predicate devices, not AI/ML performance.
Approval Date: The 510(k) was cleared in 2004, well before the widespread application of AI/ML in medical device performance evaluation as you've described in your questions.
Focus of the Document: A 510(k) summary primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily extensive novel performance studies in the way you've outlined for AI/ML systems.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/ML device because this document does not pertain to such a device or study.

What the document does provide regarding performance:

VIII. Performance Data:

Static and dynamic testing of the NOVEL™ VBR Spinal System was performed. The test results demonstrated that the NOVEL™ VBR Spinal System is at least comparable to, if not better than those of the predicate devices.

Based on the available document, I cannot complete your request. It describes a physical medical device (a spinal implant) and its mechanical testing, not an AI/ML diagnostic or assistive device that would have acceptance criteria for algorithms, ground truth creation by experts, or MRMC studies.

Summary

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

NOVEL™ VBR Spinal System 510(k) SUMM August 200

K042201

l. Company: Alphatec Manufacturing, Inc. 6110 Corte Del Cedro Carlsbad, CA 92009, USA (760) 431-9286

OCT 7 - 2004

II. Contact Person: Ellen Yarnall, Director of Regulatory Affairs
III. Trade/Proprietary Name: NOVEL™ VBR Spinal System
IV. Classification: MQP (888.3060) Vertebral Body Replacement Device

V. Product Description

VI. Intended Use:

VII. Substantial Equivalence:

The NOVEL™ VBR Spinal System is substantially equivalent to the following predicate devices

Trade/Proprietary Name	Manufacturer	Clearance
Verte-Stack Spinal System	Medtronic Sofamor Danek	K021791
DePuy AcroMed Stackable Cage	DePuy AcroMed	K990148

VIII. Performance Data:

Static and dynamic testing of the NOVEL™ VBR Spinal System was performed. The test results demonstrated that the NOVEL™ VBR Spinal System is at least comparable to, in not better than those of the predicate devices.

Page 1 of 1

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

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized emblem consisting of three wavy lines, which are meant to represent the human services provided by the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JCT 2 - 2004

Ellen A. Yarnall Director of Regulatory Affairs Alphatec Manufacturing, Inc. 6110 Corte Del Cedro Carlsbad, California 92009

Re: K042201

Trade/Device Name: NOVEL™ VBR Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 12, 2004 Received: August 13, 2004

Dear Ms. Yarnall:

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 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.

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

Page 2 - Ms. Ellen A. Yarnall

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millerson

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known):	K041226
---------------------------	---------

Device Name: NOVEL™ VBR Spinal System

Indications for Use:

The Novel™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Novel™ VBR System is intended for use with supplemental spinal fixation systems. Specifically, the Novel™ VBR System is to be used with the Alphatec Zodiac™ Polyaxial Pedicle Screw System or the Alphatec Mirage™ Top Tightening Spinal System. Furthermore, the Novel™ VBR System is intended for use with bone graft.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office, of Device Evaluation (ODE)

Mark N Millesser

Division of General, Restorative, and Neurological Device

510(k) Number K04220

Page 1 of 1

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.