The Vista® P Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 – L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). - The Vista® P Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Vista® P Vertebral Body Replacement may be used with bone graft.

Device Description

The Vista" P Vertebral Body Replacement (VBR) System is comprised wholly of unfilled PEEK Optima material. This VBR system accommodates replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine. The device must be implanted in pairs and cannot be used singly. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability. Radiopaque markers are press fit into the device to identify the boundary of the device in intra and postoperative imaging.

AI/ML Overview

The provided text describes a 510(k) submission for the Zimmer Trabecular Metal Technology, Inc. Vista® P Vertebral Body Replacement System. However, it does not describe:

Acceptance criteria in the typical sense of a target performance metric (e.g., sensitivity, specificity, accuracy). Instead, "Performance Data" refers to mechanical testing.
A study proving the device meets acceptance criteria related to diagnostic performance or AI algorithm performance. This is a medical device, not an AI/imaging diagnostic device.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this specific document as it pertains to a physical medical implant device and its mechanical performance, not a diagnostic algorithm.

Here's an attempt to answer the questions based only on the provided text, highlighting the information that is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Type)	Reported Device Performance
Mechanical performance per established ASTM standards	"The results of this performance testing demonstrated that the device will perform as intended and is equivalent to the cited predicate devices."
Substantial equivalence to predicate devices for indications for use	"The Vista P Vertebral Body Replacement System is substantially equivalent to the predicate devices identified in this premarket notification."

Note: The document does not specify quantitative acceptance criteria (e.g., "must withstand X N of force," or specific fatigue life endpoints). It states performance against "established ASTM standards" and equivalence to predicates.

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

Not Applicable. This document reports on mechanical performance testing of an implantable device, not a diagnostic algorithm evaluated on a patient data test set. The "test set" would likely refer to a number of physical devices subjected to mechanical tests, but the sample size is not specified.
Data Provenance: Not applicable in the context of patient data. The mechanical testing would have been conducted in a controlled lab environment.

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 context of diagnostic algorithms, typically refers to expert labels or pathology results. For mechanical testing, the "ground truth" is adherence to engineering standards and comparison to predicate devices, not expert consensus on patient data.

4. Adjudication method for the test set

Not Applicable. This is relevant for studies involving human interpretation or labeling of data, not for mechanical device testing.

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 physical medical device, not an AI-based diagnostic tool. No MRMC study was conducted or is relevant here.

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

Not Applicable. This is a physical medical device. There is no algorithm to be evaluated in a standalone manner.

7. The type of ground truth used

For mechanical performance: Adherence to "established ASTM standards" and comparison to "cited predicate devices."
For regulatory conclusion: Substantial equivalence based on design, materials, and intended use compared to legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. This is a physical medical device. There is no concept of a "training set" in the context of this 510(k) submission.

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

Not Applicable. (See #8)

Summary

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

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter NameAnd Address:	Zimmer Trabecular Metal Technology, Inc.80 Commerce DriveAllendale, New Jersey 07401-1600
Contact Person:	Robert A Poggie, PhD SEP 2 2 2006
Phone Number:	(201) 818-1800 x122
Fax Number:	(973) 884-6082
Date Prepared:	April 25, 2006
Device Trade Name:	Vista ® P Vertebral Body Replacement System
Device Common Name:	Vertebral Body Replacement Device
Classification Number,Product Code, & Name:	21 CFR § 888.3060MPQ; Spinal Vertebral Body Replacement Device

Substantial The term "substantial equivalence" as used in this 510(k) notification is Equivalence: limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

The Vistas P Vertebral Body Replacement System is designed to be used as a Device Description: replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated.

The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability. Radiopaque markers are press fit into the device to identify the boundary of the device in intra and postoperative imaging.

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

Indications for Use: The Vista P Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in the thoracolumbar spine (T1 -- L5) to replace a collapsed, damaged or unstable vertebral body due to turnor or trauma (i.e., fracture). The Vista P Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Vista" P Vertebral Body Replacement may be used with bone graft.

Device Technological The device is similar in design, geometry and sizing to the predicate Characteristics and devices and possesses identical indications for use. The unfilled PEEK Comparison to Optima LT-1 material has been used in cited predicates for the same Predicate Device: intended and indications for use.

Performance Data: The subject Vista" P devices were mechanically tested per established ASTM standards. The results of this performance testing demonstrated that the device will perform as intended and is equivalent to the cited predicate devices.

Conclusion:

The Vista P Vertebral Body Replacement System is substantially equivalent to the predicate devices identified in this premarket notification.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services. The seal features the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping figures or abstract shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2006

Zimmer Trabecular Metal Technology, Incorporated c/o Dr. Robert A. Poggie 80 Commerce Drive Allendale, New Jersey 07401-1600

Re: K061155

Trade Name: Vista-P Device Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 28, 2006 Received: August 29, 2006

Dear Dr. Poggie:

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.

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

Page 2 - Dr. Robert A. Poggie

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.

Ybarbare friehund
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

K061155: Zimmer Trabecular, Vista-P Device 510k Number:

Indications For Use

OR...

Prescription Use >< (Per 21 CFR 801.109)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lavon Brown

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

510(k) Number K061155

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.