The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

Device Description

The Quantum Vertebral Body Replacement is a generally box-shaped device with various holes located throughout its geometry. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium or polyetheretherketone (PEEK).

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the "Quantum Vertebral Body Replacement." It describes the device, its intended use, and states that "Mechanical testing indicates that the Quantum Vertebral Body Replacement is capable of performing in accordance with its intended use."

However, this document does not contain any information regarding specific acceptance criteria, detailed study designs (including sample sizes, data provenance, expert qualifications, or adjudication methods), or performance metrics beyond a general statement about mechanical testing.

Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data elements are not present in the provided text.

Based on the provided input, the following information is unavailable:

A table of acceptance criteria and the reported device performance: No specific acceptance criteria or quantitative performance metrics are listed. The document only states that mechanical testing indicates the device is "capable of performing in accordance with its intended use."
Sample sized used for the test set and the data provenance: No information on test set sample size or data provenance is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device (a physical implant) would typically rely on mechanical testing rather than expert-established ground truth on images or clinical data in this context.
Adjudication method for the test set: Not applicable.
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, as this is a physical medical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as the evaluation type appears to be mechanical testing.
The sample size for the training set: Not applicable, as this is a physical medical implant and not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary

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APR 1 2 2006

510(k) Summary Quantum Vertebral Body Replacement

Manufacturer IdentificationSubmitted by:	Quantum Orthopedics, Inc.2744 Loker Ave. W., Suite 100Carlsbad, CA 92010760-607-0121
Contact Information:	Jason BlainChief Technology OfficerQuantum Orthopedics, Inc.2744 Loker Ave. W., Suite 100Carlsbad, CA 92010760-607-0121iblain@quantumorthopedics.com
Date Prepared:	September 22, 2005
Device IndentificationProprietary Name:	Quantum Vertebral Body Replacement
Common Name:	Vertebral Body Replacement
Classification Name:	Spinal Vertebral Body Replacement

Predicate Devices

The subject device is substantially equivalent to the previously cleared Quantum Vertebral Body Replacement.

Device Description

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Intended Use of the Device

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

Performance Data

Mechanical testing indicates that the Quantum Vertebral Body Replacement is capable of performing in accordance with its intended use.

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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 features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2006

Quantum Orthopedics, Incorporated c/o Jason Blain Chief Technology Officer 2744 Loker Ave. W., Suite 100 Carlsbad, California 92010

Re: K052641

Trade/Device Name: Quantum Veretebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: II Product Code: MQP Dated: March 14, 2006 Received: March 15, 2006

Dear Mr. Blain:

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. Dr to 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, inting 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 - Mr. Jason Blain

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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,
elmee

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

510(k) Number: K052641

Device Name: Quantum Vertebral Body Replacement

Indications For Use:

The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

Prescription Use X (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)

DRH, Office of Device Evaluation (ODE) Concurrence

(Division Sign-Off) Division of General, Restorer and Neurological Devices

Page 1 of 1

510(k) Number_ko52641

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.