Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or . rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head .
Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
. All forms of osteoarthritis
. Patients with hips at risk of dislocation
Femoral neck fracture or proximal fracture to hip joint .

The POLARCUP® Dual Mobility System is intended for single use only and depending on its version is to be implanted either with or without bone cement.

Device Description

The POLARCUP Dual Mobility System consists of a metal shell and plastic liner (or insert). The inside of the metal shell is polished, and the outside of the plastic liner is able to articulate against this polished surface. This dual mobility design results in higher intra-prosthetic stability to address the treatment of patients with a high risk of dislocation (especially for elderly patients) or patients with recurrent dislocation. The subject device is identical to the previously cleared POLARCUP® Dual Mobility System with the exception of an increase in the size range and the addition of Highly Crosslinked Polyethylene Liners.

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and study for the POLARCUP® Dual Mobility System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, K110135, is a 510(k) premarket notification for a medical device. For such devices, "acceptance criteria" and "device performance" are typically established through bench testing and comparison to predicate devices rather than clinical study outcomes with specific metrics like sensitivity or specificity.

Therefore, the "acceptance criteria" here relate to demonstrating substantial equivalence through mechanical testing and material characterization, and the "reported device performance" is the conclusion that these tests met the requirements for substantial equivalence.

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance
Mechanical Data	Capable of withstanding expected in vivo loading without failure (as demonstrated through various mechanical tests).	"A review of the mechanical data indicates that the POLARCUP® Dual Mobility System is capable of withstanding expected in vivo loading without failure."
Overall Design	Substantially equivalent to commercially available predicate devices.	"The overall design... for the POLARCUP® Dual Mobility System are substantially equivalent to the commercially available predicate devices identified." The specific changes (increase in size range, addition of highly crosslinked polyethylene liners) did not alter substantial equivalence due to testing.
Materials	Substantially equivalent to commercially available predicate devices.	"The overall design, materials... for the POLARCUP® Dual Mobility System are substantially equivalent to the commercially available predicate devices identified."
Indications for Use	Substantially equivalent to commercially available predicate devices.	"The overall design, materials, and indications for use for the POLARCUP® Dual Mobility System are substantially equivalent to the commercially available predicate devices identified."
Specific Testing	Wear, coating characterization, range of motion, stress analysis, and fatigue properties deemed acceptable for substantial equivalence.	"Wear Testing, Coating Characterization, Range of Motion Testing, Stress Analysis and Fatigue Properties were evaluated for the determination of substantial equivalence." (Implies results were acceptable).
Safety and Effectiveness	Demonstrated to be safe and effective for its intended use, based on substantial equivalence to predicate devices (as determined by the FDA).	FDA's 510(k) clearance indicates that the device is "substantially equivalent... to legally marketed predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

This is a physical medical device (implantable hip component), not a diagnostic algorithm or software. Therefore, the concept of a "test set" and "data provenance" in the context of clinical images or patient data does not apply in the same way.

Sample Size for Test Set: Not applicable in the traditional sense of patient data. The "test set" would refer to the number of devices or components used in mechanical and material testing. The document does not specify the exact number of units tested for each mechanical evaluation (Wear Testing, Coating Characterization, Range of Motion Testing, Stress Analysis, and Fatigue Properties).
Data Provenance: The data comes from in vitro mechanical and material testing conducted by Smith & Nephew, Inc. There is no information regarding country of origin for the data or whether it's retrospective or prospective, as these terms are relevant for clinical studies, not bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in this context would be scientifically established standards for material and mechanical performance testing, as well as regulatory standards for demonstrating substantial equivalence. The document does not mention the use of experts to establish a "ground truth" for the test data itself. The interpretation and assessment of the test results would be conducted by qualified engineers and regulatory affairs personnel within Smith & Nephew, and ultimately reviewed by FDA experts.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations of clinical data, particularly in diagnostic studies. This document describes a submission for a physical implant, where performance is assessed through objective mechanical and material tests.

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 is not an AI-assisted diagnostic device, nor is it a device that involves human "readers" interpreting clinical cases. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on established engineering and material science principles and regulatory standards for mechanical and material performance of hip prosthetic components. This includes:

Industry standards for wear testing (e.g., ISO standards for orthopedic implants).
Material property specifications for titanium alloys, polyethylene, and porous coatings.
Biomechanical principles for stress analysis and fatigue life.
The performance characteristics of the predicate devices (K070278 POLARCUP Dual Mobility System and K083116 VERSAFIT Double Mobility System) against which the subject device is being compared for substantial equivalence.

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, as there is no training set for this type of medical device submission.

Summary

{0}------------------------------------------------

K110135

OCT 1 4 2011

> We are smith&nephew

Smith & Nephew, Inc. Summary of Safety and Effectiveness

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	October 10, 2011
Contact PersonManager	Theresa Leister, Regulatory Affairs Project
	T (901) 399-5899F (901) 566-7816
Name of Device:	POLARCUP® Dual Mobility System
Common Name:	Acetabular Component
Device Classification Name and Reference:	21 CFR 888.3358 Hip jointmetal/polymer/metal semi-constrainedporous-coated uncemented prosthesis
	21 CFR 888.3390 Hip joint femoral (hemi-hip)metal/polymer cemented or uncementedprosthesis.
	21 CFR 888.3350 Hip joint metal/polymersemi-constrained cemented prosthesis.
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	LPH, KWY, JDI
Predicate Devices:	POLARCUP Dual Mobility System510(k): K070278Product Codes: LPH, KWY
	VERSAFIT Double Mobility System510(k): K083116

Device Description

Product Code: MEH

{1}------------------------------------------------

K110135 (pg. 2 of 2)

recurrent dislocation. The subject device is identical to the previously cleared POLARCUP® Dual Mobility System with the exception of an increase in the size range and the addition of Highly Crosslinked Polyethylene Liners.

Technological Characteristics

A review of the mechanical data indicates that the POLARCUP® Dual Mobility System is capable of withstanding expected in vivo loading without failure.

Intended Use

The POLARCUP® Dual Mobility System is indicated for:

Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or . rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head .
Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, � hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
. All forms of osteoarthritis
. Patients with hips at risk of dislocation
Femoral neck fracture or proximal fracture to hip joint .

The POLARCUP® Dual Mobility System is intended for single use only and depending on its version is to be implanted either with or without bone cement.

Substantial Equivalence Information

The overall design, materials, and indications for use for the POLARCUP® Dual Mobility System are substantially equivalent to the commercially available predicate devices identified.

Wear Testing, Coating Characterization, Range of Motion Testing, Stress Analysis and Faligue Properties were evaluated for the determination of substantial equivalence.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

OCT 1 4 2011

Smith & Nephew, Inc. Orthopaedic Division % Ms. Theresa Leister Regulatory Affairs Project Manager 1450 East Brooks Road Memphis. Tennessee 38116

Re: K110135 Trade/Device Name: POLARCUP Dual Mobility System 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, KWY, JDI Dated: October 10, 2011 Received: October 13, 2011

Dear Ms. Leister:

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.

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Ms. Theresa Leister

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,

Erin D. Keith

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

Enclosure

{4}------------------------------------------------

Premarket Notification Indications for Use Statement

510(k) Number (if known): _K110135

Device Name: POLARCUP® Dual Mobility System

Indications for Use:

The POLARCUP® Dual Mobility System is indicated for:

Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or . rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head ●
Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
All forms of osteoarthritis .
Patients with hips at risk of dislocation .
Femoral neck fracture or proximal fracture to hip joint .

The POLARCUP® Dual Mobility System is intended for single use only and depending on its version is to be implanted either with or without bone cement.

Prescription Use X AND/OR Over-the-Counter Use (Part 21 CFR 801.109) (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Quay for MXM

of Surgical, Orthopedic,

K n 0135

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.