The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in 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 Longevity Integrated Taper (IT) Constrained Liner is a modular acetabular shell liner intended to capture the femoral head of a total hip prosthesis to reduce the incidence of joint dislocation. The liners feature integral polyethylene "fingers" reinforced with a modular Tivanium® ring to capture the mating femoral head. The Longevity IT Constrained Liners are intended to mate with Continuum and Trilogy IT acetabular shells.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the Longevity® IT Highly Crosslinked Polyethylene Constrained Liner. It details the device's description, intended use, and substantial equivalence to predicate devices, supported by non-clinical performance data.

Here's an analysis of the document for the requested information:

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

The document states that "Non-Clinical testing was conducted on the proposed device per FDA's Guidance Document, "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis". This testing demonstrated that the Longevity IT Constrained Liners performed as intended and met all acceptance criteria."

However, the specific quantitative acceptance criteria (e.g., minimum load for pull-out, maximum displacement, etc.) and the precise reported device performance values for each test are not explicitly listed in this summary. The summary only names the types of tests performed.

Test Name	Acceptance Criteria	Reported Device Performance
Head Pull-Out Fatigue Test	Not explicitly stated, but implied adherence to FDA guidance "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis".	Performed as intended and met all acceptance criteria (specific values not provided in this summary).
Rim Impingement Fatigue Test	Not explicitly stated, but implied adherence to FDA guidance "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis".	Performed as intended and met all acceptance criteria (specific values not provided in this summary).
Static Head Pull-Out Test	Not explicitly stated, but implied adherence to FDA guidance "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis".	Performed as intended and met all acceptance criteria (specific values not provided in this summary).
Static Rim Impingement Lever-Out Test	Not explicitly stated, but implied adherence to FDA guidance "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis".	Performed as intended and met all acceptance criteria (specific values not provided in this summary).
Liner Locking Mechanism Strength Analysis	Not explicitly stated, but implied adherence to FDA guidance "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis".	Performed as intended and met all acceptance criteria (specific values not provided in this summary).
Anatomic Fatigue Analysis	Not explicitly stated, but implied adherence to FDA guidance "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis".	Performed as intended and met all acceptance criteria (specific values not provided in this summary).
Constrained Liner Wear Performance	Not explicitly stated, but implied adherence to FDA guidance "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis".	Performed as intended and met all acceptance criteria (specific values not provided in this summary).
Liner Durability and Backside Wear	Not explicitly stated, but implied adherence to FDA guidance "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis".	Performed as intended and met all acceptance criteria (specific values not provided in this summary).
Temperature Effects on Liner Assembly	Not explicitly stated, but implied adherence to FDA guidance "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis".	Performed as intended and met all acceptance criteria (specific values not provided in this summary).
Interaction of MRI with World Cup Implants	Not explicitly stated, but implied adherence to FDA guidance "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis".	Performed as intended and met all acceptance criteria (specific values not provided in this summary).

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

The document describes non-clinical performance testing. This refers to laboratory-based mechanical and materials testing of the device, not clinical data involving human subjects. Therefore, the concepts of "test set sample size," "country of origin," "retrospective or prospective" for human patient data are not applicable here. The testing was conducted on samples of the device itself. The specific number of devices tested for each non-clinical test is not specified in this summary.

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)

This question is not applicable to this submission. The "ground truth" in this context is established by engineering standards and FDA guidance for device performance, not by expert interpretation of patient data.

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

This question is not applicable as it pertains to clinical studies involving human subject data requiring adjudication, which was not performed for this 510(k) submission.

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

This question is not applicable as no clinical efficacy or comparative effectiveness study involving human readers or AI was conducted or reported in this 510(k) summary. The submission is based on non-clinical performance data for a mechanical implant.

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

This question is not applicable as this device is a mechanical implant and does not involve an algorithm or AI.

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

For the non-clinical performance testing, the "ground truth" is defined by established engineering and biomechanical principles, industry standards, and the specific test methodologies outlined in the FDA's "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis." The compliance with these defined performance requirements constitutes the "ground truth" for the device's safety and effectiveness.

8. The sample size for the training set

This question is not applicable as this device is a mechanical implant and does not involve a "training set" in the context of machine learning or AI.

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

This question is not applicable for the reasons stated above.

Summary

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K101730

Summary of Safety and Effectiveness

DEC - 3 2010

Sponsor:	Zimmer. Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Bradley W. StrasserAssociate, Regulatory AffairsTelephone: (574) 372-4780Fax: (574) 372-4605
Date:	14 September 2010
Trade Name:	Longevity® IT Highly Crosslinked PolyethyleneConstrained Liner
Common Name:	Total Hip Prosthesis
Classification Nameand Reference:	Hip joint metal/polymer constrained cemented oruncemented prosthesis.21 CFR § 888.3310
Product Code:	K WZ - Prosthesis, Hip, Constrained, Cemented orUncemented, Metal/Polymer
Predicate Device:	Trilogy® Longevity Constrained Liner,manufactured by Zimmer, Inc., K071718, cleared13 July 2007Continuum™ and Trilogy Integrated Taper (IT)Acetabular Systems, manufactured by Zimmer, Inc.,K091508, cleared 11 September 2009
Device Description:	The Longevity Integrated Taper (IT) ConstrainedLiner is a modular acetabular shell liner intended tocapture the femoral head of a total hip prosthesis toreduce the incidence of joint dislocation. The linersfeature integral polyethylene "fingers" reinforcedwith a modular Tivanium® ring to capture themating femoral head. The Longevity ITConstrained Liners are intended to mate with

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Page 2

Intended Use:

Comparison to Predicate Device:

Continuum and Trilogy IT acetabular shells.

The Longevity IT Constrained Liners are manufactured from the same materials and processes as their predicates. The subject device also has the same intended use and constraining mechanism as the predicate Trilogy Longevity Constrained Liner. The Longevity IT Constrained Liners have the same liner locking mechanism as the predicate Continuum and Trilogy IT Acetabular System Polyethylene Liners.

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Page 3

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

Non-Clinical testing was conducted on the proposed device per FDA's Guidance Document, "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis". This testing demonstrated that the Longevity IT Constrained Liners performed as intended and met all acceptance criteria.

The Longevity IT Constrained Liner design and geometry were evaluated to demonstrate that the proposed device met performance requirements and is as safe and effective as its predicate. This information and testing data formed the basis for a determination of substantial equivalence.

Specific Non-clinical Testing Completed:

Head Pull-Out Fatigue Test .
Rim Impingement Fatigue Test .
. Static Head Pull-Out Test
Static Rim Impingement Lever-Out Test t
Liner Locking Mechanism Strength . Analysis
. Anatomic Fatigue Analysis
Constrained Liner Wear Performance .
Liner Durability and Backside Wear .
Temperature Effects on Liner Assembly .
. Interaction of MRI with World Cup Implants

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is a stylized eagle or bird symbol, composed of three curved lines representing the wings and a wavy line representing the body.

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

Zimmer, Inc. % Mr. Bradley W. Strasser Associate. Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708 DEC - 3 2010

Re: K101730

Trade/Device Name: Longevity® IT Highly Crosslinked Polyethylene Constrained Liners 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: November 5, 2010 Received: November 8, 2010

Dear Mr. Strasser:

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. Iisting 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.

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Page 2 - Mr. Bradley W. Strasser

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 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,

Mark A. Milliman

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

K101730

DEC - 3 2010

510(k) Number (if known):

Device Name:

Longevity® IT Highly Crosslinked Polyethylene 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)

Janetta for mxm
Division Sign Co.

Division of Surgical, Orthopedic, and Resiorative Devices

510(k) Number K101730

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.”