The Endoskeleton TA VBR is for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Endoskeleton TA VBR is intended for use with supplemental internal spinal fixation systems. The Endoskeleton TA VBR may be used with bone graft material or bone graft substitute.

Device Description

The Endoskeleton TA VBR is a titanium implant that is oval in shape. The implant is available in a range of sizes in 0-7º lordotic angles, higher in the anterior than the posterior, to restore spinal lordosis. The center of the implant is hollow and can be filled with bone graft material. The device is available in a range of sizes to accommodate the individual patient's anatomic space. The surface of the implant is roughened to improve stability and resistance to expulsion. A set of customized instruments will be provided for use with the Endoskeleton TA VBR to facilitate its implantation.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Endoskeleton TA Vertebral Body Replacement). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics, or a study proving that the device meets specific performance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

Identical intended use.
Very similar indications for use and technological features.
Substantially similar implantation procedure.
A statement that "Any minor differences between the Endoskeleton TA VBR and the predicates do not raise any new types of safety or effectiveness issues, and performance data in the submission demonstrate that these differences do not adversely impact its safety or effectiveness." However, the actual performance data or the criteria against which it was measured are not detailed in this summary.

In the context of the provided text, the "study that proves the device meets the acceptance criteria" is essentially the submission demonstrating substantial equivalence to already cleared devices, rather than a specific performance study with defined acceptance criteria and reported outcomes in the way you've outlined for a typical AI/diagnostic device.

To directly answer your request based only on the provided text, I must state that the information requested is not available.

Summary

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K0328/2

DEC - 8 2003

510(K) SUMMARY FOR THE ORTHOVITA, INC. ENDOSKELETON TA VBR

Submitter's Name, Address, Telephone Number, And Contact Person

Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355 Contact: David McIlhenny (610) 407-5211 Telephone: Facsimile: (610) 640-2603

Date Prepared

September 4, 2003

Name of the Device

Endoskeleton TA Vertebral Body Replacement

Common or Usual Name

Vertebral Body Replacement

Classification Name

Vertebral Body Replacement (MQP)

Predicate Devices

DePuy Acromed Stackable Cage (K990148, K013382) ●
Synthes Vertebral Spacer Ti (K020152, K024364) .

Intended Use

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K032012

The principles of operation of the modified device are identical to the other previously cleared VBR systems. Like the predicate VBRs, the Endoskeleton TA VBR is inserted in the spine together with supplemental internal spinal fixation. Bonc graft material may be placed in and/or around the implant. One implant is inscrted per spinal level via an anterior surgical approach.

Technological Characteristics

Summary Basis for the Finding of Substantial Equivalence

The Endoskeleton TA VBR described in this submission has same intended use and very similar indications for use and technological features to a number of other previously cleared VBR devices. The implantation procedure for the Endoskeleton TA VBR also is substantially similar to other currently available VBRs. Any minor differences between the Endoskeleton TA VBR and the predicates do not raise any new tvpes of safety or effectiveness issues, and performance data in the submission demonstrate that these differences do not adversely impact its safety or effectiveness. Therefore, the Endoskeleton TA VBR is substantially equivalent.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem that features a stylized representation of a human figure, with three curved lines forming the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2003

Mr. David McIlhenny Senior Vice President, Operations Orthovita, Inc. 45 Great Valley Parkway Malvern, Pennsylvania 19355

Rc: K032812

Trade/Device Name: Orthovita Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP Dated: September 5, 2003 Received: September 9, 2003

Dear Mr. McIlhenny:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (for the indications for use stated in the enclosure) to legally marketed prodicate 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 elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David McIlhenny

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 vours.

Sincerely yours,

/ Mark N Millkerm

Celia M. Witten, Ph.D., M.D. 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 Statement

510(k) Number (if known): K032812

Device Name: Orthovita Vertebral Body Replacement

Indications for Use:

f. Mark A. Milburn

Memorogical Devices

Number K032812

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

the JSON output is:

Over-The-Counter Use -

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.