The Trilogy® Longevity® Constrained Liner is indicated for primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.

Device Description

The Trilogy Longevity Constrained Liner is a polyethylene/metal acetabular liner, which, when used with a Trilogy or Trabecular Metal ™ Modular Acetabular Shell, forms the acetabular component of a total hip prosthesis. The device consists of a Longevity Highly Crosslinked Polyethylene Liner and a Tivanium ® alloy constraining ring. The liner allows for mechanical capture of the metal femoral head and greater flexion/extension range of motion than hooded constrained liner designs.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device (Trilogy® Longevity® Constrained Liner). It focuses on establishing substantial equivalence to a predicate device based primarily on non-clinical performance (mechanical testing). Therefore, many of the requested details related to clinical studies, human readers, ground truth, and training sets are not applicable or not present in this document.

Here's the breakdown of the available information:

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

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Mechanical performance of the modified device (Trilogy Longevity Constrained Liner) should be substantially equivalent to the predicate device (Epsilon Durasul Constrained Acetabular Liner).	Mechanical testing of the modified device indicates that it is substantially equivalent to the predicate.

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

Test Set Sample Size: Not applicable. The "test set" in this context refers to the samples used for mechanical testing of the device, not a clinical data set. The specific number of devices tested is not provided, only that "mechanical testing" was performed.
Data Provenance: Not applicable for clinical data. The mechanical testing would have been performed in a laboratory setting, likely in the submitter's (Zimmer, Inc.) facilities in the USA.

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. "Ground truth" in this context is not established by human experts interpreting clinical data, but rather by objective measurements from mechanical testing as per relevant standards.

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

Not applicable. This concept primarily applies to clinical studies where expert consensus or agreement is needed for diagnoses or outcomes. Mechanical testing results are objective measurements.

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

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, as this is a mechanical medical device and not an AI or imaging diagnostic tool.

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

No. This is a mechanical medical device, not an algorithm.

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

The "ground truth" for demonstrating substantial equivalence was based on objective mechanical testing results compared against the predicate device's known performance or established standards for such devices.

8. The sample size for the training set

Not applicable. This device is not an AI or machine learning model that would require a training set.

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

Not applicable. There was no training set for this device.

Summary

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长071718

Summary of Safety and Effectiveness

JUL 1 3 2007

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Stephen McKelvey, MA, RACSenior Manager, Corporate Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 372-4605
Date:	June 20, 2007
Trade Name:	Trilogy ® Longevity ® Constrained Liner
Common Name:	Constrained Acetabular Liner
Classification Namesand References:	21 CFR 888.3310: Hip joint metal / polymerconstrained cemented or uncemented prosthesis,Product code: KWZ
Predicate Device:	Zimmer (formerly Centerpulse) Epsilon ™ Durasul ®Constrained Acetabular Liner, K030923, clearedOctober 3, 2003
Device Description:	The Trilogy Longevity Constrained Liner is apolyethylene/metal acetabular liner, which, whenused with a Trilogy or Trabecular Metal ™ ModularAcetabular Shell, forms the acetabular componentof a total hip prosthesis. The device consists of aLongevity Highly Crosslinked Polyethylene Linerand a Tivanium ® alloy constraining ring.The liner allows for mechanical capture of the metalfemoral head and greater flexion/extension range ofmotion than hooded constrained liner designs.
Intended Use:	The Trilogy Longevity Constrained Liner isindicated for primary or revision total hiparthroplasties where there is a high risk of hipdislocation due to a history of instability, bone loss,joint, muscle or tissue laxity, or disease condition.

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This device is intended for patients for whom all other options to constrained acetabular components have been considered.

The Trilogy Longevity Constrained Liner is a design modification of the Epsilon Durasul Constrained Acetabular Liner. The material has been changed to Longevity Highly Crosslinked Polyethylene, the finger and ring designs have been modified to ease assembly and the backside has been modified for use with Trilogy and Trabecular Metal Modular Acetabular Shells.

Performance Data (Nonclinical and/or Clinical):

Comparison to Predicate Device:

Non-Clinical Performance and Conclusions:

Mechanical testing of the modified device indicates that it is substantially equivalent to the predicate.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 13 2007

Zimmer, Inc. % Mr. Stephen McKelvey, MA, RAC Senior Manager, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K071718 Trade/Device Name: Trilogy® Longevity® Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: June 20, 2007 Received: June 22, 2007

Dear Mr. McKelvey:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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

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Page 2 - Mr. Stephen McKelvey, MA, RAC

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 devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrl/industry/support/index.html

Sincerely yours,

Mark McMillan

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

Enclosure

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Indications for Use

510(k) Number (if known):

K071718

Device Name:

Trilogy® Longevity® Constrained Liner

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Munk A. Milken

(Division Sign-Off (Division of General, R Division of States and Neurological De 510(k) Number

Page 1 of 1

022

Regulation Number and Section

§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”