The Zimmer Biomet™ Select Ceranic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

When used with constrained acetabular liners, the Zimmer Biomet™ Select Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

Device Description

The Zimmer Biomet™ Select™ Ceramic Heads are modular ceramic heads with a Type 1, 12/14 or 6 Degree adapter sleeve. They are offered in a variety of head diameters and neck configurations. They are intended for mating with a variety of Titanium Alloy and Cobalt-Chromium Alloy, as well as Stainless Steel, femoral stems equipped with tapered necks.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for the Zimmer Biomet™ Select™ Ceramic Heads. Since this is a submission for a medical device that does not involve artificial intelligence or machine learning, the concepts of acceptance criteria for algorithm performance, sample sizes for training/test sets, expert ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance are not applicable.

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

Intended Use and Indications for Use: The subject device has the same intended use and similar indications for use as the predicate devices.
Materials: The subject device uses similar ceramic materials that meet ISO 6472-2 standards, identical to a reference device (ICONACY™ I-Hip™ Ceramic Heads).
Design Features: Both the subject and predicate devices mate with various femoral stems with tapered necks. The subject device offers a larger range of tapers and offsets.
Sterilization: Identical to predicates.

The study that proves the device meets the acceptance criteria is a non-clinical performance study focusing on the mechanical and material characteristics of the implant. The "acceptance criteria" here are defined by the performance standards expected of such medical devices and comparison to predicate devices, rather than algorithm metrics.

Here's a breakdown of the requested information based on the provided document, acknowledging the non-AI context:

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

Acceptance Criteria Category	Specific Test/Characteristic	Reported Device Performance (Summary)
Intended Use	Identical to predicate	Same intended use as predicate devices.
Indications for Use	Similar to predicate	Similar indications for use as predicate devices.
Materials	Meets ISO 6472-2, Ceramic Composition	Made from alumina matrix composite. Meets ISO 6472-2. Identical to ICONACY™ I-Hip™ Ceramic Heads (a reference device).
Design Features	Mating with femoral stems, range of tapers/offsets	Mates with various Titanium Alloy, Cobalt-Chromium Alloy, and Stainless Steel femoral stems with tapered necks. Offers a larger range of tapers and offsets compared to predicates.
Sterilization	Method	Identical to predicates.
Mechanical Performance	Static Compression	Non-clinical tests were conducted.
	Axial Fatigue and Post-Fatigue Compression	Non-clinical tests were conducted.
	Axial Pull-Off	Non-clinical tests were conducted.
	On-axis and Off-axis Impaction and Compression	Non-clinical tests were conducted.
	Resistance to Wear and Head Retention	Considered in non-clinical tests.
	Range of Motion	Non-clinical tests were conducted.
Safety and Effectiveness	No new questions raised compared to predicates	Performance data and analyses demonstrate that differences do not raise new questions of safety and effectiveness, and the device is at least as safe and effective as legally marketed predicate devices.

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 applicable in the context of this 510(k) for a physical medical device. There are no "test sets" of data in the AI/ML sense. The "testing" refers to mechanical and material characterization of the device components. The document does not specify the number of individual units tested for each mechanical test, nor does it specify a "country of origin for data" or whether the mechanical tests were "retrospective or prospective."

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 is not applicable. "Ground truth" in the AI/ML sense (e.g., expert-labeled images) is not relevant for this medical device submission. The "ground truth" for mechanical properties is established through standardized engineering tests and material specifications.

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

This is not applicable. Adjudication methods are used for resolving disagreements in expert labeling of data, which is not part of this device 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 is not applicable. MRMC studies are specific to evaluating the impact of AI on human performance (e.g., radiologists interpreting images), which is outside the scope of this mechanical implant device.

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

This is not applicable. This device is a physical implant, not an algorithm.

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

As explained above, "ground truth" in the AI/ML context is not applicable. For this device, the "ground truth" is defined by:

Standardized Material Specifications: e.g., ISO 6472-2 for ceramic materials.
Engineering Mechanical Test Results: Bench testing of materials and device components for properties like compression, fatigue, pull-off, wear, and range of motion.
Comparison to Predicate Devices: Demonstrating that the device's characteristics are similar or equivalent to those of previously cleared devices.

8. The sample size for the training set

This is not applicable. There is no "training set" in the AI/ML sense for this device.

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

This is not applicable. There is no "training set" or corresponding "ground truth" establishment in the AI/ML sense for this device.

Summary

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December 26, 2018

Zimmer, Inc. Carol Vierling Regulatory Affairs Project Manager PO Box 708 Warsaw, Indiana 46581-0708

Re: K181761

Trade/Device Name: Zimmer Biomet Select Ceramic Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, KWY, KWZ Dated: November 28, 2018 Received: November 30, 2018

Dear Carol Vierling:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is by Vesa Vuniqi-S. The date of the signature is 2018.12.26. The time of the signature is 16:20:28 -05'00'.

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181761

Device Name Zimmer BiometTM Select Ceramic Heads

Indications for Use (Describe)

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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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Zimmer Biomet™ Select™ Ceramic Heads 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708Establishment Registration Number: 1822565
Contact Person:	Carol VierlingRegulatory Affairs Project ManagerTelephone: (706-476-2938)
Date:	November 28, 2018
Subject Device:	Trade Name: Zimmer Biomet™ Select™ Ceramic HeadsCommon Name: Ceramic Femoral Head Prosthesis
	Classification Name:• LZO— Hip joint/metal/ceramic/polymersemiconstrained cemented or nonporous uncementedprosthesis (21 CFR 888.3353)• KWZ—Hip joint femoral (hemi-hip), metal/polymercemented or uncemented prosthesis (21 CFR 888.3390)• KWZ—Hip joint metal/polymer constrained cementedor uncemented prosthesis (21 CFR 888.3310)
Primary Predicate:	K141653	Biolox® deltaOption CeramicHeads	Biomet, Inc.
Additional Predicate:	K073567	BIOLOX® OPTIONCeramic FemoralHead System	Zimmer GmbH

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K181761 Page 2 of 4

Reference Devices:	K151307	ICONACY™ I-Hip™	ICONACY Orthopedic Implants, LLC
	K960658	Collarless Polished Hip Prosthesis	Zimmer, Inc.
	K032396	RingLoc® 36mm Liners and Modular Femoral Heads	Biomet, Inc.

Purpose and Device Description:

This traditional 510(k) premarket notification is being submitted to obtain clearance for the Zimmer Biomet™ Select™ Ceramic Heads. The heads are made from an alumina matrix composite. The adapter sleeve is made from Ti-6Al-4V Alloy.

Intended Use and Indications for Use:

The Zimmer Biomet™ Select Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

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neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: Identical to the predicate ●
Indications for Use: Similar to the predicate ●
Materials: Similar to the predicate. Both ceramic . heads meet ISO 6472-2, Implants for Surgery-Ceramic Materials. Identical to the reference device, the ICONACY™ I-Hip™ Ceramic Heads, and similar manufacturing process
Design Features: Both the subject and predicate ● devices mate with a variety of femoral stems equipped with tapered necks. The variety of head diameters and neck configurations is similar although the subject device is available in a larger range of tapers and offsets.
Sterilization: Identical

Summary of Performance Data (Nonclinical and/or Clinical)

● Non-Clinical Tests:

Static Compression O
Axial Fatigue and Post-Fatigue Compression O
Axial Pull-Off O
On-axis and Off-axis Impaction and Compression O
Magnetic Resonance Imaging (MRI) studies O
Resistance to Wear and Head Retention were O considered
Range of Motion O
Clinical Tests:
- Clinical data were not deemed necessary for the O subject device.

Substantial Equivalence Conclusion

The subject device has the same intended use and similar indication for use as the predicate devices. The subject device is made of a similar material as the primary predicate device. In addition, the subject device has

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similar technological characteristics to the predicate and reference devices. The performance data and analyses demonstrate that:

o any differences do not raise new questions of safety and effectiveness; and
the proposed device is at least as safe and o effective as the legally marketed predicate devices.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.