The Quantum Vertebral Body Replacement System 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).

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 System is composed of a flanged VBR body with screw holes and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry and teeth on its external surfaces. Screws pass through screw holes and affix to bone to help prevent implant migration. The devices are available in a multitude of sizes and are made from titanium and polyetheretherketone (PEEK).

AI/ML Overview

The provided text describes a medical device, the Quantum Vertebral Body Replacement System, and its intended use, but it does not include the detailed information requested regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert ground truth establishment, or multi-reader comparative effectiveness studies.

The document is a 510(k) summary for a medical device submitted to the FDA for clearance. It focuses on demonstrating substantial equivalence to a predicate device and includes information about the device's description, intended use, and a statement about performance data.

Here's a breakdown of what can be extracted and what is missing:

What is present in the document:

Device Identification: Quantum Vertebral Body Replacement System
Intended Use: To replace a collapsed, damaged, or unstable vertebral body in the thoracic and/or thoracolumbar spine (T1-L5) due to tumor or trauma (fracture), to be used with supplemental spinal fixation systems.
Performance Data Statement: "Mechanical testing indicates that the Quantum Vertebral Body Replacement System is capable of performing in accordance with its intended use."

What is missing from the document and therefore cannot be provided in the requested format:

A table of acceptance criteria and the reported device performance: The document only states "Mechanical testing indicates that the Quantum Vertebral Body Replacement System is capable of performing in accordance with its intended use." It does not specify any quantitative acceptance criteria (e.g., minimum strength, fatigue life, displacement limits) nor does it provide reported numerical performance results against such criteria.
Sample size used for the test set and the data provenance: Not mentioned. The "performance data" refers to mechanical testing, not a clinical study with a test set of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a mechanical device, not an AI/imaging device requiring expert interpretation for ground truth.
Adjudication method for the test set: Not applicable for mechanical testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is a mechanical implant, not an AI system assisting human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical implant, not an algorithm.
The type of ground truth used: For mechanical testing, "ground truth" would be the engineering specifications and validated test methods. The document does not detail these.
The sample size for the training set: Not applicable. This is a mechanical device, not an AI system requiring a "training set."
How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary focuses on the regulatory clearance process for a mechanical medical device through substantial equivalence to a predicate, rather than providing detailed performance study data against specific acceptance criteria for a diagnostic or AI-based device. Therefore, the majority of the requested information, which pertains to performance studies for software-based or diagnostic devices, is not available in the given text.

Summary

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K061576 Quantum Orthopedics, Inc. Special 510(k) – Quantum Vertebral Body Replacement System Page 1 of 2

510(k) Summary Quantum Vertebral Body Replacement System

JUL - 3 2006

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 92010760-607-0121jblain@quantumorthopedics.com
Date Prepared:	June 6, 2006
Device IdentificationProprietary Name:	Quantum Vertebral Body Replacement System
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

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).

Performance Data

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

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Image /page/2/Picture/1 description: The image shows a circular logo with a stylized depiction of a bird in the center. The bird is composed of three curved lines that suggest movement or flight. Surrounding the bird is a circular arrangement of text, although the specific words are not legible due to the image's resolution. The logo appears to be a symbol for an organization or entity, possibly related to aviation, nature, or a government agency.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2006

Quantum Orthopedies. Inc. c.o Mr. Jason Blain. Chief Technology Officer 2744 Loker Ave. W., Suite 100 Carlsbad. CA 92010

Re: K061576

Trade Name: Quantum VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 6, 2006 Received: June 7, 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, 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.

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Page 2 - Mr. Blain

Please be advised that FDAs issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements not hast 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 lectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 100, 11050. This letter will allow you to begin marketing your device as described in your Scetion 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legal|y marketed predicate device results in a classification for your device and thus, permitts 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 mon ohtain 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/industrv/support/index.html.

Sincerely yours,

Charbang buelirp

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:	K061576
Device Name:	Quantum Vertebral Body Replacement System

Indications For Use:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sharbare Buchund for MCM
(Division Sign-Off)

Division of Ger and Neurologics

510(k) Number K061576

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.