The Trabecular Metal Acetabular Augment System is intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

Device Description

Trabecular Metal Acetabular Augments provide an alternative to structural allograft for augmenting moderate to large-sized segmental acetabular defects encountered in acetabular reconstruction. The Trabecular Metal Buttress and Column-Buttress Augments possess a truncated hemispherical geometry with integral flanges. The Shim Augments are space / void filler and bridge gaps between bone and other acetabular reconstructive hardware. These devices are available in several sizes and geometries to accommodate the wide range and location of bone deficiencies often encountered in revision acetabular surgery.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Zimmer Trabecular Metal Technology, Inc.'s Trabecular Metal Acetabular Augments. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics.

Therefore, the requested information for acceptance criteria and a study proving their fulfillment cannot be extracted from this document, as such a study is not part of a 510(k) submission that relies on substantial equivalence. This type of submission aims to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily that it meets novel performance criteria.

However, I can provide a summary based on the information that is present concerning the device and its regulatory pathway:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of performance metrics. The underlying acceptance criterion for a 510(k) is "substantial equivalence" to predicate devices. This implies that the device is as safe and effective as the predicate based on material properties, design, indications for use, and technological characteristics.
Reported Device Performance: Not reported in terms of specific performance data (e.g., mechanical strength, wear rates, biological response). The performance is inferred to be similar to the predicate devices through the substantial equivalence argument.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical or performance study with a test set. The submission relies on a comparison to predicate devices, not de novo testing against a patient or cadaveric test set.

3. 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. No test set or ground truth establishment by experts is described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication process is described.

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 medical implant, not an AI-assisted diagnostic device.

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

Not applicable. This is a medical implant, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth is established or used, as no specific performance study is detailed for this 510(k) submission.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a study involving machine learning or statistical model training.

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

Not applicable. No training set or ground truth establishment is mentioned.

Summary of 510(k) Process as it Relates to "Acceptance Criteria"

In the context of this 510(k) notification, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The listed predicate devices are:

K042871 Trabecular Metal Acetabular Augments (12/31/04, Zimmer TMT)
K012507 The Trabecular Metal Technology Acetabular Augment System (8/30/01, Implex Corp.)
K001471 The Implex Hedrocel Acetabular Augment System (8/7/00, Implex Corp.)

The basis for this "acceptance" by the FDA is the determination that the new device has the same intended use and the same technological characteristics as the predicate devices, or, if there are differences in technological characteristics, that those differences do not raise different questions of safety and effectiveness. This is a comparative assessment rather than a direct measurement against predefined performance thresholds for a standalone claim.

Summary

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MAY 2 5 2006

K041067 Page

Zimmer Trabecular Metal Technology, Inc.

Trabecular Metal Acetabular Augments 510(k) Premarket Notification

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Trabecular Metal Acetabular Augments Submitter Name: Zimmer Trabecular Metal Technology, Inc. (Z-TMT) Submitter Address: 80 Commerce Drive Allendale, New Jersey 07401-1600 Contact Person: Robert A Poggie Phone Number: (201) 818-1800 X 122 Fax Number: (973) 884-6082 Date Prepared: April 13, 2006 Device Trade Name: Trabecular Metal Acetabular Augments Device Common Acetabular augmentation devices for total hip replacement Name: acetabular components Classification Number: 21 CFR § 888.3358 Substantial The term "substantial equivalence" as used in this Equivalence: 510(k) notification is 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. Device Description: Trabecular Metal Acetabular Augments provide an alternative to structural allograft for augmenting moderate to large-sized segmental acetabular defects encountered in acetabular reconstruction. The Trabecular Metal Buttress and Column-Buttress Augments possess a truncated hemispherical geometry with integral flanges. The Shim Augments are space / void filler and bridge gaps between bone and other acetabular reconstructive hardware. These devices are available in several sizes and geometries to accommodate the wide range and location of bone deficiencies often encountered in revision acetabular surgery.

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Zimmer Trabecular Metal Technology, Inc.

Trabecular Metal Acetabular Augments 510(k) Premarket Notification

510(k) Summary (Continued)

Indications for Use: The Trabecular Metal Acetabular Augment System is intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

Predicate Devices: The predicated devices for which substantial equivalence has been documented herein are:

K042871 Trabecular Metal Acetabular Augments (12/31/04, Zimmer TMT)
K012507 The Trabecular Metal Technology Acetabular Augment System (8/30/01, Implex Corp.)
K001471 The Implex Hedrocel Acetabular Augment System (8/7/00, Implex Corp.)
Conclusion: The Trabecular Metal Acetabular Augments are substantially equivalent to the identified predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2006

Mr. Robert A. Poggie, Ph.D. Director, Global Brand Management Zimmer Trabecular Metal Technology, Inc. 80 Commerce Drive Allendale, New Jersey 07401

Re: K061067
Trade/Device Name: Trabecular Metal Acetabular Augment System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: April 13, 2006 Received: April 17, 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.

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

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Page 2 - Mr. Robert A. Poggie, Ph.D.

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,

Herbert Lehman

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

Enclosure

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Zimmer Trabecular Metal Technology, Inc.

Trabecular Metal Acetabular Augments 510(k) Premarket Notification

510 (k) Number (if known) :

KORIOET

Device Name:

Trabecular Metal Acetabular Augments

Indications For Use:

Trabecular Metal Acetabular Augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR . . .

Over-The -Counter Use

(21 CFR 801 Subpart C) (Optional Format 09-2004)

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Helmut Lerner

Division of General, Restorative, and Neurological De

510(k) Number K061067

April 13, 2006

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.