The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The system is intended for use either with or without bone cement in total hip arthroplasty.

Device Description

The proposed Continuum and Trilogy IT Acetabular System Shells are a line extension to the predicate modular acetabular shells, with a smaller 40 mm outer diameter. The Longevity IT Elevated Liner in this submission is offered in a size to be used with the 40 mm Continuum and Trilogy IT Shells above and has a 22 mm articulation diameter. The Longevity IT Offset and Oblique Liners are modular acetabular cup liners intended to be used with the Continuum and Trilogy IT Acetabular Systems. Offset Liners have a head center that is offset 7 mm beyond the acetabular shell center of rotation and the Oblique Liners have a liner face and head center tilted by 10° relative to the acetabular shell rim.

AI/ML Overview

The provided document describes the Zimmer Continuum® and Trilogy® IT Acetabular Systems & Longevity® IT Highly Crosslinked Polyethylene Elevated, Offset, and Oblique Liners. This is a medical device for total hip arthroplasty. The document details the non-clinical performance and conclusions, but explicitly states that clinical data and conclusions were not needed for this device. This means there was no study involving human subjects or expert readers to evaluate its performance against specific acceptance criteria in a clinical setting as would typically be done for AI/diagnostic devices.

Therefore, many of the requested elements for an AI/diagnostic device's acceptance criteria and study design are not applicable to this submission.

Here's an analysis based on the provided text, addressing the applicable points:

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

Since this is a non-clinical evaluation of a hip prosthesis, the "acceptance criteria" are related to mechanical and physical performance rather than diagnostic accuracy. The document lists the specific non-clinical tests conducted, implying that the device "met performance requirements." However, the specific quantitative acceptance criteria for each test (e.g., "liner push-out force must exceed X Newtons") and the actual numerical results are not explicitly detailed in this summary.

Acceptance Criteria Category (Implied)	Reported Device Performance
Liner Push-Out Evaluation	Met performance requirements
Liner Lever-Out Evaluation	Met performance requirements
Liner Torque-Out Evaluation	Met performance requirements
Rim Deformation Testing	Met performance requirements
Liner Locking Mechanism Strength Analysis	Met performance requirements
Anatomic Fatigue Testing	Met performance requirements
Liner Wear Performance	Met performance requirements
Liner Durability and Backside Wear	Met performance requirements
Temperature Effects on Liner Assembly	Met performance requirements
Interaction of MRI with Implants	Met performance requirements
Range of Motion Evaluation	Met performance requirements
Shell Fatigue and Deformation Evaluation	Met performance requirements

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

This information is not provided because the study was non-clinical (mechanical testing of physical devices), not a clinical study involving patients or data. The "test set" would refer to the number of physical liners and shells subjected to each mechanical test. This specific quantity is not disclosed in the summary document.

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 for mechanical testing is established by engineering specifications and measurements, not expert human interpretation.

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

Not applicable. Adjudication methods are relevant for subjective human assessments, not objective mechanical testing.

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 device is a physical hip prosthesis, not an AI diagnostic tool that assists human readers.

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

Not applicable. This is not an algorithm.

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

For non-clinical performance, the "ground truth" implicitly refers to engineering specifications, material science standards, and biomechanical requirements for an implantable device to function safely and effectively within the human body. For example, a "liner push-out" test would have an engineering specification for the minimum force required to dislodge the liner, and the measured force would be compared against that.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. This is a physical device, not an AI model.

In summary: The provided document is a 510(k) premarket notification for a medical device (hip prosthesis) based entirely on non-clinical performance testing. It states that "Clinical data and conclusions were not needed for this device" because it is a line extension of previously cleared predicate devices and it met performance requirements through various mechanical and material tests. Therefore, questions related to clinical studies, expert readers, AI performance, and AI training/ground truth are not relevant to this specific submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle is the word "zimmer" in a smaller, sans-serif font.

102662

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

2011

.. '

Summary of Safety and Effectiveness

APR 1 5 2011

Sponsor:

Contact Person:

Date:

Trade Name:

Common Name:

Classification Name

and Reference:

Predicate Device:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

ি ।

Rebecca M. Brooks Specialist, Regulatory Affairs Telephone: (574) 371-8033 Fax: (574) 372-4605

February 10, 2011

Continuum® and Trilogy® IT Acetabular Systems Longevity® IT Highly Crosslinked Polyethylene Elevated Liners Longevity® IT Highly Crosslinked Polyethylene Offset Liners Longevity® IT Highly Crosslinked Polyethylene Oblique Liners

Total Hip Prosthesis

LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented 21 CFR § 888.3358

JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented 21 CFR § 888.3350

LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented 21 CFR § 888.3353

Continuum® and Trilogy® IT Acetabular Systems, manufactured by Zimmer, K091508, cleared 11 September 2009

p. 1 of 3

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Page 2 February 10, 2011

1-103662

Continuum® and Trilogy® IT Acetabular Systems & Longevity® IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, K101229, cleared 03 December 2010

Trilogy® Acetabular System Longevity® Liners, manufactured by Zimmer, K990135, cleared 12 July 1999

The proposed Continuum and Trilogy IT Acetabular System Shells are a line extension to the predicate modular acetabular shells, with a smaller 40 mm outer diameter. The Longevity IT Elevated Liner in this submission is offered in a size to be used with the 40 mm Continuum and Trilogy IT Shells above and has a 22 mm articulation diameter. The Longevity IT Offset and Oblique Liners are modular acetabular cup liners intended to be used with the Continuum and Trilogy IT Acetabular Systems. Offset Liners have a head center that is offset 7 mm bevond the acetabular shell center of rotation and the Oblique Liners have a liner face and head center tilted by 10° relative to the acetabular shell rim.

The system is intended for use either with or without bone cement in total hip arthroplasty.

The Continuum and Trilogy IT Acetabular Shells and Longevity IT Highly Crosslinked Polyethylene Elevated, Offset, and Oblique Liners are manufactured, packaged, and sterilized using

400

2 of 3

Device Description:

Intended Use:

Comparison to Predicate Device:

Intended Use:

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Page 3 February 10, 2011

103662

Performance Data (Nonclinical and/or Clinical):

equivalent materials and processes as their predicates. The subject devices also have the same intended use as their predicates.

Non-Clinical Performance and Conclusions:

Non-clinical testing demonstrated that the Continuum and Trilogy IT Acetabular Shells and the Longevity IT Elevated, Offset, and Oblique Liners met performance requirements.

The Longevity IT Elevated, Offset, and Oblique Liners were evaluated in terms of design and geometry to demonstrate that the devices meet performance requirements and are as safe and effective as their predicate. This information and testing data formed the basis for a determination of substantial equivalence.

Specific Non-clinical Testing Completed:

. Liner Push-Out Evaluation
. Liner Lever-Out Evaluation
Liner Torque-Out Evaluation .
. Rim Deformation Testing
. Liner Locking Mechanism Strength Analysis
Anatomic Fatigue Testing .
Liner Wear Performance .
Liner Durability and Backside Wear .
Temperature Effects on Liner Assembly .
Interaction of MRI with Implants .
Range of Motion Evaluation .
. Shell Fatigue and Deformation Evaluation

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

p. 3 of 3

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest feathers. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Zimmer, Inc. % Ms. Rebecca M. Brooks Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708

APR 1 5 2011

Re: K103662

Trade/Device Name: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, JDI Dated: March 18, 2011 Received: March 21, 2011

Dear Ms. Brooks:

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

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Page 2 - Ms. Rebecca M. Brooks

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.

Aky B. R. h
fer

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

K103662 510(k) Number (if known):

Device Name:

Continuum and Trilogy Integrated Taper (IT) Acetabular Systems Shells & Longevity IT Highly Crosslinked Polyethylene Elevated, Offset, and Oblique Liners

Indications for Use:

The system is intended for use either with or without bone cement in total hip arthroplasty.

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)

	for M.Melkerson	Page 1 of 1
(Division Sign-Off)
Division/of Surgical, Orthopedic, and Restorative Devices
510(k) Number	K103662

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.