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 titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement. The POLARCUP® Dual Mobility System is intended for single use only.

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 of this premarket notification is the addition of an outer hydroxylapatite coating to the currently available acetabular shell.

AI/ML Overview

The provided text is a 510(k) summary for the POLARCUP® Dual Mobility System, a medical device. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/software validation.

Instead, this document describes:

The device (POLARCUP® Dual Mobility System) and its components (metal shell, plastic liner).
Its intended use (treatment of advanced degeneration of the hip joint, fractures, failures of previous hip surgery, osteoarthritis, and patients at high risk of dislocation).
Its classification and regulatory information.
Its technological characteristics, specifically noting that mechanical data indicates it can withstand in vivo loading.
Its substantial equivalence to predicate devices (other hip prostheses from Smith & Nephew).
A brief conclusion that, based on similarities to predicates and mechanical testing, the device is substantially equivalent.

Therefore, I cannot provide the requested information because the document does not describe acceptance criteria for an AI/software device, nor does it detail a study that proves such a device meets acceptance criteria.

The questions you've asked (about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are all highly relevant to the validation of AI/Software as a Medical Device (SaMD) or AI-enabled medical devices. This document, however, is for a physical orthopedic implant and does not involve AI or software in the way your questions imply.

Summary

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122244

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AUG 2 3 2012

510(k) Summary POLARCUP® Dual Mobility System

Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
Date of Summary:	July 26, 2012
Contact Person	John Connor, Regulatory Affairs SpecialistT (901) 399-5944 F (901) 566-7961
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 prosthesis21 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

Device Description

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

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K12224.4p

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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 .

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.

Substantial Equivalence Information

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

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & NephewOrthopaedics AG	SL-PLUS° Standard and Lateral Femoral Stems	K120211	7/19/12
Smith & NephewOrthopaedics AG	POLARCUP® Dual Mobility System	K110135	10/14/11

All tests which are in relation to the surface characterization (physical, chemical or mechanical) are discussed in detail in the Ti/HA Coating Master File MAF - 1762, Amendment 1 and are not included in this dossier.

Conclusion

As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the POLARCUP® Dual Mobility System. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the commercially available predicate devices listed above.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

AUG 23 2012

Smith & Nephew, Incorporated % Mr. John Connor Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova. Tennessee 38016

Re: K122244

Trade/Device Name: POLARCUP® Dual Mobility Systems Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, KWY, JDI Dated: July 26, 2012 Received: July 27, 2012

Dear Mr. Connor:

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 - Mr. John Connor

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.

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

Sincerely yours.

Enclosure

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Premarket Notification Indications for Use Statement

510(k) Number (if known):

POLARCUP® Dual Mobility System Device Name:

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

Prescription Use X (Part 21 CFR 801.109)

AND/OR

Over-the-Counter Use (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)

Asht

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122244

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.