The NOVEL™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) to replace 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.

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 various shapes and sizes to meet individual patient anatomy. System components are manufactured from titanium alloy (ASTM F-136) or polyetheretherkeytone (PEEK) material (ASTM F 2026 and ISO 10993). A radiographic marker fabricated from titanium alloy (ASTM F-136) or tantalum (ASTM F-560) allows for easy radiographic identification.

AI/ML Overview

This document, K050553 for the NOVEL™ VBR Spinal System, is a 510(k) premarket notification. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The document states:

"Performance data were submitted to characterize the NOVEL™ VBR Spinal System manufactured from PEEK material." (Section VIII)
It refers to "substantial equivalence" to a previously cleared device.
It is a regulatory clearance document, not a performance study report.

Therefore,Based on the provided document, the following information about acceptance criteria and a study proving the device meets those criteria cannot be found or inferred:

A table of acceptance criteria and the reported device performance: This document does not specify any quantitative acceptance criteria for the device's performance, nor does it present device performance data in a table or any other format that would allow for comparison to such criteria.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No information regarding sample sizes for any test sets, data provenance, or study design (retrospective/prospective) is provided. The document mentions "Performance data were submitted to characterize," but does not detail the specifics of this data or the studies generating it.
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): Since no clinical performance study is described, there is no mention of experts, ground truth establishment, or their qualifications.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: No adjudication method is mentioned as no test set or clinical assessment is detailed.
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: This is a spinal surgical implant, not an AI-powered diagnostic device. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is a physical medical implant and not an algorithm, the concept of standalone algorithm performance is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is discussed as no clinical performance study is detailed.
The sample size for the training set: There is no mention of a training set, as this is a physical device and not a machine learning model.
How the ground truth for the training set was established: Not applicable, as there is no training set for an algorithm.

In summary, this document is a 510(k) clearance letter confirming that the FDA found the NOVEL™ VBR Spinal System substantially equivalent to a predicate device. It does not contain the detailed performance study information with acceptance criteria that you are requesting.

Summary

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K050553
Page 1 of

l. Alphatec Manufacturing, Inc. Company: 6110 Corte Del Cedro Carlsbad, CA 92009, USA (760) 431-9286
Ellen Yarnall, Director of Regulatory Affairs Contact Person: 11.
NOVEL™ VBR Spinal System ��. Trade/Proprietary Name:
MQP (888.3060) Vertebral Body Replacement Device IV. Classification:

Product Description: V.

VI. Intended Use:

VII. Substantial Equivalence:

The NOVEL™ VBR Spinal System is substantially equivalent to the previously cleared NOVEL™ VBR Spinal System manufactured from titanium alloy.

VIII. Performance Data:

Performance data were submitted to characterize the NOVEL™ VBR Spinal System manufactured from PEEK material.

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Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Public Health Service

APR 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050553

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: March 25, 2005 Received: March 25, 2005

Dear Ms. Yarnell:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your bectorn b x(x) fee device is substantially equivalent (for the indications ferenced above and nave decemblied by arketed predicate devices marketed in interstate for use statu in the encrosare) (o regars) to regars the Medical Device Amendments, or 10 commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug. devices mat nave occh recuired in asses approval of a premarket approval application (PMA). allu Cosmette Act (71ct) that do her required to the general controls provisions of the Act. The r ou may, mercere, mance of the Act include requirements for annual registration. Iisting of general controls provisions of ractice, 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 It hay be subject to such additions, Title 21, Parts 800 to 898 In addition. FDA can be found in the Oouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuated or a occeeded complies with other requirements of the Act that I DA has made a actorimiations administered by other Federal agencies. You must of ally it cleral statures and regulations daminds. but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTK Fart 807), adding (21 CFR Part 820), and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820), 1980-1950 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Ellen A. Yarnell

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter whil anow you to oegin manteeing your million of your device to a legally premarket notification: "The PDT Intentig stification 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 If you desire specific advice for your as 101) 276-0120 . Also, please note the regulation entitled, Connact the Office of Companise notification" (21CFR Part 807.97). You may obtain of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

Miriam C. Provost, Ph.D. Acting 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

510(k) Number (if known): K0505S3

Device Name: NOVEL™ VBR Spinal System

Indications for Use:

× 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)

R. A. M.

ACTIVE

05053

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.