The Vista S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista® S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista -S Device is implanted via an anterior approach.

The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.

Device Description

The Vista -- S Device is a box-shaped device for interbody fusion and vertebral body replacement fabricated from polyetheretherketone (PEEK). The Vista -S currently cleared to accommodate the replacement of a vertebral body in the thoracic and lumbar region of the spine. Use of this device is expanded to include use as a cervical interbody fusion device at one level from C2-T1. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Vista®-S Device. This submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of diagnostic performance against acceptance criteria in the way one might for an AI/ML medical device.

Based on the information provided, here's a breakdown of the requested points:

A table of acceptance criteria and the reported device performance

Acceptance Criterion Topic	Acceptance Criteria	Reported Device Performance
Substantial Equivalence	Device is substantially equivalent to legally marketed predicate devices.	The Vista®-S Device was shown to be substantially equivalent. No significant differences that would adversely affect use. No new issues of safety or efficacy.
Material	Identical or similar material to previously cleared predicate devices.	Identical material to previously cleared predicate devices.
Intended Use/Indications	Similar to predicate devices.	Similar to its predicate devices. Expanded indications for cervical interbody fusion (C2-T1) in addition to existing thoracolumbar vertebral body replacement (T1-L5).
Design Features/Geometry	Similar to cleared predicate devices.	Similar to cleared predicate devices.
Mechanical Performance	Adequately meets predetermined requirements established for its mechanical performance as per FDA guidance.	Mechanical testing results and analyses demonstrate that the proposed system adequately meets predetermined requirements.

Sample size used for the test set and the data provenance

This document describes mechanical testing and comparison to predicate devices for a physical implant, not a study involving a "test set" of patient data or images in the way an AI/ML diagnostic device would. There is no mention of a clinical test set, patient data, or provenance (country of origin, retrospective/prospective). The "test set" here refers to the actual device units subjected to mechanical tests.
- Sample Size: Not specified for mechanical testing, but typically involves a certain number of devices per test.
- Data Provenance: Not applicable in the context of device mechanical testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a diagnostic device involving expert ground truth for interpretation. Ground truth for mechanical testing would be defined by engineering specifications and standards.
Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations. Mechanical testing results are objective measurements against predefined engineering standards.
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

No, an MRMC study was not done. This device is a physical implant (interbody fusion device/vertebral body replacement), not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This is a physical medical device.
The type of ground truth used

For the mechanical performance testing, the ground truth would be established by engineering standards and specifications based on recommendations from the FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device. For the substantial equivalence argument, the "ground truth" is the established safety and efficacy of the predicate devices.
The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established

Not applicable. As above, there is no training set for this type of medical device submission.

Summary

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

K11983 Page 1 of 2

510(k) Summary

NOV 1 8 2011

Submitter:	Zimmer Trabecular Metal Technology, Inc.10 Pomeroy RoadParsippany, New Jersey 07054
Contact Person:	Kathleen RutherfordAssociate Director, Regulatory AffairsTelephone: (973) 576-0139Fax: (973) 884-8792
Date:	July 8, 2011
Trade Name:	Vista®-S Device
Common Name:	Intervertebral body fusion device & Spinal Vertebral Body Replacement
Classification Name:	Intervertebral fusion device, 21 CFR § 888.3080,Spinal vertebral body replacement device, 21 CFR § 888.3060
Device Panel/Product Code:	Orthopedic ODP & MQP

Device Description:

Indications for Use:

The Vista -S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista -S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista -S Device is implanted via an anterior approach.

The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.

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

Device Technological Characteristics and Comparison to Predicate Device(s):

The Vista -S Device was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include this Vista -S Device as a VBR (K070382). C-Thru by EBI (K092336). NUBIC by SIGNUS (K082848), TM-S Fusion Device by Zimmer TMT (K 103033), and Vista® P Device by Zimmer TMT (K061155).

The Vista -S Device has the identical material as previously cleared predicate devices. The intended use and indications for use of the subject device are similar to those of its predicate devices. The sizes, design features and overall geometry of the device in the current submission are similar to the cleared predicate devices.

There are no significant differences between the Vista®S Device and the predicate devices currently being marketed that would adversely affect the use of the product. Any differences in technological characteristics do not raise new issues of safety or efficacy. The subject system is similar to its predicate devices with respect to intended use/indications for use, material, technological characteristics and basic principles of operation.

Performance Data:

Mechanical testing was performed on the Vista -S Device as recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device. The results of testing and analyses conducted demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance.

Substantial Equivalence:

The Vista -S Device is substantially equivalent to its predicate devices with respect to intended use/indications for use, materials, technological characteristics and basic principles of operation as demonstrated by the supporting performance testing data.

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

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV 1 8 2011

Zimmer Trabecular Metal Technology, Inc. % Ms. Kathleen Rutherford Associate Director, Regulatory Affairs 10 Pomeroy Road Parsippany, New Jersey 07054

Re: K111983

Trade/Device Name: Vista -S Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: October 28, 2011 Received: October 31, 2011

Dear Ms. Rutherford:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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

. Page 2 -- Ms. Kathleen Rutherford

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours

Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K111983

Device Name: Vista -S Device

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1_of_1

(Division Sign-Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KI11983 510(k) Number_

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.