The TM Ardis® Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies: Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.

The TM Ardis® Interbody System device is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

Device Description

The TM Ardis® Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-SI. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "TM Ardis® Interbody System." This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than a clinical study evaluating diagnostic accuracy or a human-AI comparison. Therefore, many of the requested categories related to clinical studies, ground truth, expert involvement, and AI performance metrics are not applicable or cannot be extracted from this specific document.

Here's the breakdown of the information that can be extracted and a clear indication of what cannot be determined:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by the referenced ASTM standards and FDA guidance documents for mechanical performance. The reported performance is a qualitative statement of compliance.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance
Mechanical Performance	- ASTM F2077-03: Test Methods for Intervertebral Body Fusion Devices	The proposed system adequately meets the predetermined requirements established for its mechanical performance.
	- ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
	- Guidance for Industry and FDA Staff; Spinal Systems 510(k)s; May 3, 2004
	- Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007
Specific Tests	- Axial Compression - Static and Dynamic	(Implicitly meets these standards)
	- Compression Shear - Static and Dynamic	(Implicitly meets these standards)
	- Subsidence	(Implicitly meets these standards)
	- Torsion - Static and Dynamic	(Implicitly meets these standards)
	- Expulsion	(Implicitly meets these standards)

Study Details

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. This document refers to mechanical testing of the device itself, not a clinical study involving human patients or a test set of data. The "sample size" would refer to the number of devices tested, which is not specified but would be aligned with standard mechanical test protocols.
- Data Provenance: Not applicable, as it's mechanical testing, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. Ground truth, in this context, would be the physical properties and performance metrics measured during mechanical testing, established by engineering and testing standards, not by human experts interpreting clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a clinical study requiring adjudication of expert interpretations.
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 document describes mechanical testing of an intervertebral body fusion device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assistance evaluation was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: The "ground truth" for this device is its physical and mechanical performance characteristics as measured against established engineering standards (ASTM F2077-03, ASTM F2267-04) and FDA guidance documents for intervertebral body fusion devices. This is a physical/mechanical ground truth, not a clinical or diagnostic ground truth.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device submission.

Summary

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MAY 2 9 2012

510(k) Summary

Submitter:	Zimmer Trabecular Metal Technology, Inc.10 Pomeroy RoadParsippany, New Jersey 07054
Contact Person:	Judith RosenSenior Regulatory Affairs SpecialistTelephone: (973) 576-0032 ext. 28138Fax: (973) 884-8792Email: judith.rosen@zimmer.com
Date:	May 25, 2012
Trade Name:	TM Ardis® Interbody System
Common Name:	Intervertebral body fusion device
Classification Name:	Intervertebral body fusion device, Lumbar 21 CFR § 888.3080,

Device Panel/Product Code:Orthopedic / MAX

Device Description:

Indications for Use:

The TM Ardis® Interbody System device is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

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

The TM Ardis® Interbody System was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include the Ardis® Interbody System by Zimmer Spine

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(K073202), Lucent® Lumbar Interbody System by Spinal Elements (K071724), TM-S Fusion Device by Zimmer Trabecular Metal Technology (K103033).

The TM Ardis® Interbody System has the identical material as previously cleared TM-S 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 TM Ardis® Interbody System 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 TM Ardis® Interbody System in accordance with ASTM F2077-03: Test Methods for Intervertebral Body Fusion Devices. ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression, Guidance for Industry and FDA Staff; Spinal Systems 510(k)s; May 3, 2004 and Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007 and was comprised of the following tests; Axial Compression - Static and Dynamic, Compression Shear - Static and Dynamic, Subsidence, Torsion - Static and Dynamic and Expulsion. 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 TM Ardis Interbody System 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.

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

Zimmer Trabecular Metal Technology, Incorporated % Ms. Judith Rosen Senior Regulatory Affairs Specialist 10 Pomeroy Road Parsippany, New Jersey 07054

MAY 2 9 2012

Re: K113561

Trade/Device Name: TM Ardis® Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 03, 2012 Received: May 04, 2012

Dear Ms. Rosen:

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 aboye) 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

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Page 2 - Ms. Rosen

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Pat De Lee-

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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Zimmer Trabecular Metal Technology, Inc. Traditional 510(k) - TM Ardis® Interbody System

Indications for Use

KIT3561 510(k) Number (if known):

Device Name: TM Ardis® Interbody System (TM TPLIF)

Indications for Use:

The TM Ardis® Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration i of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.

The TM Ardis® Interbody System device is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

KII3561 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.