CO Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T1-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR Ø6.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

Device Description

The CO Vertebral Body Replacements are rectangular shaped in pairs for full corpectomy or individually when only a portion of the vertebral body is resected. The interior of the spacers is open to provide space for bone graft. The implant is always implanted in the vertical position. These components are available in various heights (7mm-150mm) and cross sections to accommodate the variability of patient size, anatomic variation, and the size of the vertebral body defect. The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation and migration. The body has a multitude of holes to allow additional impaction of bone graft.

The CO components are fabricated from pure poly(ether cther ketone) (PEEK). This material closely matches the modulus of elastical bone, improving the biomechanical interface and reducing the stress shielding effect. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. I wo metal wires at the opposite cads of the spacers allow radiological confirmation of the cage position post operatively.

AI/ML Overview

This 510(k) summary describes a spinal implant device (CO Vertebral Body Replacements) and therefore does not include information about acceptance criteria or a study proving that the device meets them in the context of device performance metrics like sensitivity, specificity, accuracy, etc., which are typically found for AI/ML-driven devices or diagnostic tools.

Instead, the documentation focuses on demonstrating substantial equivalence to a predicate device based on its design, materials, and intended use. The "study" mentioned is a non-clinical summary that compares the new device to a previously cleared one.

Therefore, many of the requested categories (e.g., sample size for test/training sets, experts, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Summary of Nonclinical Tests)
Design, Shape, Strength: Demonstrated to be similar to the predicate device.	The CO Vertebral Body Replacement is a modification to the Scient'x Ellys VBR (K033109). It is similar in design, shape, and strength.
Material: Demonstrated to be manufactured from the same material as the predicate device.	It is manufactured from the same material (pure poly(ether cther ketone) (PEEK)) as the predicate device.
Indications for Use: Demonstrated to have the same indications for use as the predicate device.	It has the same indications (vertebral body replacements for use in the lumbar and thoracic spine (T4-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma) as the predicate device.

2. Sample size used for the test set and the data provenance

Not Applicable. This is a mechanical device, and the "test set" in this context refers to the non-clinical comparative analysis against a predicate device, not empirical data from a study with patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth, in the sense of expert consensus on medical images or diagnoses, is not relevant for the regulatory clearance of this mechanical spinal implant based on substantial equivalence.

4. Adjudication method for the test set

Not Applicable. See above.

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 a mechanical spinal implant, not an AI-driven diagnostic or assistive device.

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

Not Applicable. This is a mechanical device.

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

The ground truth for this submission is based on the previously cleared predicate device (Scient'x Ellys VBR, K033109). The "truth" is established by demonstrating that the new device shares fundamental technological characteristics with a device already deemed safe and effective.

8. The sample size for the training set

Not Applicable. This is a mechanical device, and there is no "training set" in the computational sense.

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

Not Applicable. See above.

In summary: The provided document is a 510(k) summary for a mechanical spinal implant. The regulatory pathway for such devices typically relies on demonstrating substantial equivalence to an existing, legally marketed predicate device, rather than extensive clinical trials or performance studies with acceptance criteria as would be seen for diagnostic software or AI/ML devices. The "study" mentioned is a non-clinical comparison focusing on design, materials, and intended use.

Summary

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

CO Vertebral Body Replacement 510(k) Summary March 22, 2005

1150348

Submitter	Scient'xBatiment CalypsoParc Ariane 378284 GuyancourtFRANCE	MAY 27 2005
Contact person	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199
Trade Name	CO Vertebral Body Replacement
Common name	Vertebral Body Replacement Device
Classification name	Class II per 21 CFR section 888.3060
Product Code	MQP
Equivalent Device	Scient'x Ellys VBR (K033109)

Device Description

Intended Use

CO Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T4-L5) to replace a damaged, collapsed or unstable vertebral body duc to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR Ø6.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

Summary Nonclinical Tests

The CO Vertebral Body Replacement is a modification to the Scient x Ellys VBR (K033109). It is similar in design, shape, strength, is manufactured from the same material and has the same indications.

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

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The logo is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 2005

Scient'X C/o Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K050348

Trade/Device Name: CO Vertebral Body Replacements Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 5, 2005 Received: May 9, 2005

Dear Mr. Webb:

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- Mr. J.D. Webb

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,

Atyat Purdu

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

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

Indications for Use

510(k) Number (if known): _ K050348

Device Name: CO Vertebral Body Replacements

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Stupt Rhodes

Orvision Sign-Off Division of General, Remative and Neurological Devices

510(k) Number K050348

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.