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 (NID) 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 Continuum and Trilogy IT Acetabular Systems are modular acetabular cup systems intended to replace a hip joint and designed to achieve fixation to bone either with or without bone cement. The systems consist of porous coated shells, optional dome and screw hole plugs, and highly cross-linked polyethylene (HXPE) liners. The shells with screw holes permit the use of previously cleared Tivanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient. The dome and screw hole plugs may be placed by the surgeon into any unused holes in the shell.

AI/ML Overview

The provided document is a 510(k) premarket notification for a hip implant system (Continuum and Trilogy Integrated Taper (IT) Acetabular Systems). It specifically details a labeling modification to add Magnetic Resonance Imaging (MRI) compatibility information.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the criteria for demonstrating MRI compatibility, not the clinical effectiveness or safety of the hip implant itself as a medical device for its primary intended use.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (for MRI Compatibility)	Reported Device Performance (Summary)
MR Conditional Labeling	Device is recommended to bear the "MR Conditional" labeling.
Inclusion of MR Compatibility Safety Information in Package Insert	MR compatibility safety information is to be included within the package insert.

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 explicitly stated in terms of a "sample size" for patients or devices tested in a clinical setting. The evaluation was for the device itself rather than human subjects.
Data Provenance: The study was a non-clinical performance evaluation, so country of origin of data (in terms of patient origin) is not applicable. It was a prospective evaluation of the device's MRI compatibility.

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. The ground truth for MRI compatibility is established by engineering and physics principles and testing, not by expert medical consensus in this context.

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

Not applicable. This was a non-clinical, technical evaluation.

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 MRMC or AI study was conducted. This submission is for MRI compatibility of a hip implant, not an AI-powered diagnostic device.

6. 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.

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

The ground truth for the MRI compatibility testing was based on results obtained from testing the physical device(s) against established standards and guidance documents for MRI compatibility. This would typically involve measurements of magnetic force, torque, heating, and artifact generation in an MRI environment.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. (See #8)

Summary of the Study:

The study referenced is a non-clinical performance evaluation that assessed the Continuum and Trilogy IT Acetabular Systems for compatibility in the Magnetic Resonance (MR) environment. This evaluation was conducted per the FDA's "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" Guidance for Industry and FDA Staff.

Based on the results of this evaluation, the conclusion was that the device met the criteria for "MR Conditional" labeling and that MR compatibility safety information should be included in the product's package insert. This indicates that the device has undergone specific testing to determine its behavior and safety within an MRI magnetic field, and conditions for safe scanning have been established. "MR Conditional" means that the device can be safely scanned under specified conditions (e.g., static magnetic field strength, gradient magnetic field, radiofrequency field).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

August 13, 2015

Zimmer, Inc. Mr. Paul Hardy Specialist. Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

Re: K151448

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, JDI, LZO Dated: June 12, 2015 Received: June 15, 2015

Dear Mr. Hardy:

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 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

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K151448 (page 1/1)

Device Name

Continuum and Trilogy Integrated Taper (IT) Acetabular systems

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font, also in blue. The logo is simple and modern, with a focus on the company's name and a distinctive initial.

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

Summary of Safety and Effectiveness Sponsor: Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 Contact Person: Paul Hardy Specialist, Regulatory Affairs Telephone: (574) 372-4257 Fax: (574) 372-4605 August 11, 2015 Date: Trade Name: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems including: Continuum IT and Trilogy IT Shells Longevity IT Highly Crosslinked Polyethylene Neutral Liners Longevity IT Highly Crosslinked Polyethylene Elevated Liners Product Codes / Device: LPH, JDI, LZO Regulation Number / Description: 21 CFR § 888.3358- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented 21 CFR § 888.3350- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented 21 CFR § 888.3353- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous. Uncemented Predicate Devices: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems, manufactured by Zimmer, K091508, cleared September 11, 2009 Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, K093846, cleared February 4, 2010

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	Longevity Integrated Taper (IT) Highly CrosslinkedPolyethylene Elevated Liners, Continuum andTrilogy Integrated Taper (IT) Acetabular SystemShells, manufactured by Zimmer, K101229, clearedDecember 3, 2010
	Continuum and Trilogy Integrated Taper HighlyCrosslinked Polyethylene Elevated, Offset, &Oblique Liners, manufactured by Zimmer,K103662, cleared April 15, 2011
Device Description:	The Continuum and Trilogy IT Acetabular Systemsare modular acetabular cup systems intended toreplace a hip joint and designed to achieve fixationto bone either with or without bone cement. Thesystems consist of porous coated shells, optionaldome and screw hole plugs, and highly cross-linkedpolyethylene (HXPE) liners. The shells with screwholes permit the use of previously cleared Tivaniumalloy screws to provide additional fixation andsecurity, particularly in those cases whereacetabular bone stock is deficient. The dome andscrew hole plugs may be placed by the surgeon intoany unused holes in the shell.
Intended Use:	The system is indicated for primary or revisionsurgery in skeletally mature individuals forrehabilitating hips damaged as a result ofnoninflammatory degenerative joint disease(NIDJD) or its composite diagnoses ofosteoarthritis, avascular necrosis, protrusioacetabuli, traumatic arthritis, slipped capitalepiphysis, fused hip, fracture of the pelvis, anddiastrophic variant. The system is intended for useeither with or without bone cement in total hiparthroplasty.
Comparison to Predicate Device:	This submission is for a labeling modification. Thelabeling modification consists of the addition ofMagnetic Resonance Imaging (MRI) compatibilityinformation to the Package Insert, and theapplication of the "MR Conditional" symbol on thepackage label.
Performance Data (Nonclinical	Non-Clinical Performance and Conclusions:

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and/or Clinical):

The Continuum and Trilogy IT Acetabular Systems have been evaluated for compatibility in the MR environment per Guidance for Industry and FDA Staff,"Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." Based upon the results, the subject device is recommended to bear the "MR Conditional" labeling and include MR compatibility safety information within the package insert.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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.