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

Device Description

The existing, commercially available Trabecular Metal Vertebral Body Reconstruction System is intended for use in thoracolumbar (TI-L5) surgical cases to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Reconstruction System is wholly comprised of Trabecular Metal Porous Tantalum (tantalum deposited on a vitreous carbon skeleton) and is available in a variety of configurations to accommodate the anatomical requirements of different patients.

The Trabecular Metal Vertebral Body Replacement System Instrumentation Set which is the subject of this premarket notification is intended for use in these thoracolumbar surgical cases and facilitates the implantation of the Trabecular Metal Vertebral Body Replacement implant system. The provisionals size the surgical site in order to determine the appropriate TM-400 implant size. The straight inserter and tamp facilitate implantation of the TM-400 implant via anterior or lateral lumbar approach. All instruments included in the set are made from 17-4 stainless steel.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study for the Trabecular Metal Vertebral Body Replacement System Instrumentation:

Device Description:
The device in question is the Trabecular Metal™ Vertebral Body Replacement System Instrumentation Set. This set facilitates the implantation of the Trabecular Metal Vertebral Body Replacement implant system in thoracolumbar (T1-L5) surgical cases. The instruments (provisional sizers, straight inserter, and tamp) are made from 17-4 stainless steel.

Lack of Specific Acceptance Criteria and Performance Data in the Summary:
It's crucial to note that the provided 510(k) summary does not explicitly state specific numerical acceptance criteria or detailed device performance metrics in a table format. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance targets for the instrumentation set itself.

The key statement regarding performance is: "The results of testing and analyses conducted demonstrate that the worst cases of the proposed instruments adequately meet the predetermined requirements established for its mechanical performance." This is a high-level summary and lacks the granular detail requested.

Given this, I will construct the table based on the most relevant information provided about the study's scope and outcome.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (as implied/stated)	Reported Device Performance (as implied/stated)
Mechanical Performance	Instruments must adequately meet "predetermined requirements" for mechanical performance in worst-case scenarios.	"The results of testing and analyses conducted demonstrate that the worst cases of the proposed instruments adequately meet the predetermined requirements established for its mechanical performance."
Material Composition	Instruments must be made from suitable materials for surgical use.	"All instruments included in the set are made from 17-4 stainless steel."
Intended Use/Indications for Use	Instrumentation must be suitable for use in thoracolumbar (T1-L5) spine for vertebral body replacement due to tumor or trauma, with supplemental internal spinal fixation systems and bone graft.	The instrumentation "facilitates the implantation of the Trabecular Metal Vertebral Body Replacement implant system" for its stated indications for use. The device is found "substantially equivalent... with respect to intended use/indications for use."
Functionality (Sizing)	Provisionals must accurately size the surgical site.	"The provisionals size the surgical site in order to determine the appropriate TM-400 implant size."
Functionality (Implantation)	Inserter and tamp must facilitate TM-400 implant via anterior or lateral lumbar approach.	"The straight inserter and tamp facilitate implantation of the TM-400 implant via anterior or lateral lumbar approach."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "worst cases of the proposed instruments" and "testing and analyses," but does not provide a numerical sample size for the test set.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective. It is implied to be laboratory/bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. The testing described appears to be mechanical/bench testing of instruments rather than a clinical study requiring expert assessment of outcomes or images.
Adjudication method for the test set:
- Not applicable / Not provided. The study described is mechanical testing, which typically involves objective measurements against engineering specifications rather than human adjudication.
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 conducted. This device is a surgical instrumentation set, not an AI-powered diagnostic tool. Therefore, a study comparing human reader performance with and without AI assistance is irrelevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a manual surgical instrument set, not an algorithm or AI system. Standalone performance of an algorithm is not relevant here.
The type of ground truth used:
- The "ground truth" for this type of device (surgical instruments) would be engineering specifications and mechanical performance requirements. The test results would be compared against these predefined physical and functional specifications. The summary states "predetermined requirements established for its mechanical performance."
The sample size for the training set:
- Not applicable / Not provided. This is a hardware surgical instrument set, not a machine learning or AI model. Therefore, there is no "training set" in the context of an algorithm.
How the ground truth for the training set was established:
- Not applicable. As a manual surgical instrument set, there is no "ground truth for a training set" as would be relevant for an AI device. The design and manufacturing would adhere to established engineering principles and material science.

Summary

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93127

510(k) Summary

Submitter:	Zimmer Trabecular Metal Technology, Inc.MAR - 4 201010 Pomeroy RoadParsippany, New Jersey 07054
Contact Person:	Kathleen RutherfordAssociate Director, Regulatory AffairsTelephone: (973) 576-0139Fax: (973) 884-8792
Date:	September 15, 2009
Trade Name:	Trabecular MetalTM Vertebral Body Replacement SystemInstrumentation Set
Common Name:	Vertebral Body Replacement Device Instrumentation Set
Classification Name andReference:	Spinal Intervertebral Body Fixation Orthosis21 CFR § 888.3060, MQP

DEVICE DESCRIPTION

Zimmer TMT. Inc. Traditional 510(k) - Trabecular Metal Vertebral Body Replacement System Instrumentation

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INDICATIONS FOR USE

DEVICE TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE(S)

Zimmer Trabecular Metal Technology, Inc. has submitted documentation demonstrating the substantial equivalence of the proposed instrument set to its predicate devices. The subject instrument set is similar to its predicate devices with respect to intended use/indications for use, materials, and basic principles of operation.

PERFORMANCE DATA

The results of testing and analyses conducted demonstrate that the worst cases of the proposed instruments adequately meet the predetermined requirements established for its mechanical performance.

SUBSTANTIAL EQUIVALENCE

The redesigned Trabecular Metal™ Vertebral Body Replacement System Instrument Set is substantially equivalent to the predicate instruments with respect to intended use/indications for use, technological characteristics and basic principles of operation. As demonstrated by supporting tests and descriptions, this minor redesign does not present any new issues of safety or effectiveness.

Zimmer TMT, Inc.

Traditional 510(k) - Trabecular Metal Vertebral Body Replacement System Instrumentation

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of 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 or other bird-like figure, with its wings spread and head facing to the left.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MAR - 4 2010

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

Re: K093127

Trade/Device Name: Trabecular Metal Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: February 23, 2010 Received: February 25, 2010

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 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

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Page 2 - Ms. Kathleen Rutherford

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 A. Milliken

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

Enclosure

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Indications for Use

510(k) Number (if known): K0913127

Device Name: Trabecular Metal™ Vertebral Body Replacement System Instrument Set

Indications for Use:

The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in thoracolumbar spine (TI-L5) to replace a collapsed, damaged or unstable vertebral body duc to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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

510(k) Number K093127

Zimmer TMT, Inc. Traditional 510(k) - Trabecular Metal Vertebral Body Replacement System Instrumentation

Page 15

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.