Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Device Description

Subject of this Traditional 510(k) premarket notification is a modification to the R3 22-36mm XLPE Acetabular Liners. The liners were originally cleared under K070756. Four vents have been added to the locking detail of the subject liners. The vents have been added to allow for improved fluid egress from behind the locking beads in an effort to minimize the potential for difficulty seating the liners during aggressive impaction.

AI/ML Overview

K113848 is a 510(k) premarket notification for a modification to an existing device, the R3 XLPE Acetabular Liners, not a study involving AI or human readers. The provided text describes mechanical testing performed to demonstrate that the modified device is substantially equivalent to predicate devices, and thus does not include the typical elements of an AI-based regulatory submission.

Therefore, many of the requested categories are not applicable to this submission.

Here is the information that can be extracted or deduced from the provided document:

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

The document mentions that the submission was prepared in accordance with the "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995. This guidance document would contain the specific acceptance criteria for each test. The actual numerical acceptance criteria for each test are not explicitly stated in the provided text, nor are the specific numerical results.

Acceptance Criteria (Not explicitly stated in provided document)	Reported Device Performance
Mechanical performance aligned with "Guidance Document for Testing Acetabular Cup Prostheses" (May 1995)	"A review of the mechanical data indicates that the R3 22-36mm XLPE Acetabular Liners are capable of withstanding expected in vivo loading without failure."
	"A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."

The following types of mechanical tests were performed:

Push-out Testing
Torque-to-Failure Testing
Lever-out Testing
Fatigue Testing
Post-Fatigue Push-out Testing

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

Sample Size: Not specified in the provided text.
Data Provenance: The document does not specify the country of origin for the test data. Given the "Submitted by Smith & Nephew, Inc. Advanced Surgical Devices Division, Cordova, Tennessee," it is highly likely the testing was conducted in the USA or by a facility contracted by a US entity for a US submission. The testing is a prospective assessment of the device's mechanical properties, not human-derived data.

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. This submission is for a medical device (acetabular liners) and involves mechanical testing, not a diagnostic algorithm that requires expert-established ground truth from images or clinical data. The "ground truth" here is the physical performance of the device against engineering standards.

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

Not applicable. As this is mechanical testing of a physical device, there is no expert adjudication process in the sense of clinical interpretations or diagnoses. The "adjudication" is compliance with engineering standards and guidance.

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. No MRMC study was conducted. This device is a physical implant, not an AI-assisted diagnostic tool. No human readers or AI were involved in the testing for this submission.

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

Not applicable. This is a physical medical device. There is no algorithm to evaluate.

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

The "ground truth" for this submission is established through physical mechanical testing according to recognized engineering standards and FDA guidance documents (specifically, the "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995). The acceptance criteria outlined in such guidance documents serve as the standard for performance.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical testing for a physical medical device. This term applies to machine learning models.

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

Not applicable. As above, there is no training set for a physical device's mechanical testing.

Summary

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K113848

APR 2 7 2012

510(k) Summary R3 XLPE Acetabular Liners

Submitted by:

Smith & Nephew, Inc. Advanced Surgical Devices Division 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

April 23, 2012

Contact Person and Address: John Connor, Regulatory Affairs Specialist T (901) 399-5944 F (901) 566-7961

Name of Device:

Date of Summary:

Common Name:

Device Classification Name and Reference:

Smith & Nephew, Inc R3 XLPE Acetabular Liners

Acetabular Liners

21 CFR 888.3358 Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis

21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

	21 CRF 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	MBL, MEH, LZO, JDI

Device Description

Technological Characteristics

This 510(k) was prepared in accordance with the Agency's, "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995. A review of the mechanical data indicates that the R3 22-36mm XLPE Acetabular Liners are capable of withstanding expected in vivo loading without failure. The following mechanical testing of the R3 XLPE Liners was performed:

Push-out Testing .
Torque-to-Failure Testing ●
Lever-out Testing ●
Fatigue Testing ●
Post-Fatigue Push-out Testing ◆

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A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.

Intended Use

The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Substantial Equivalence Information

The substantial equivalence of the R3 XLPE Liners is based on its similarities in indications for use, design features, operational principles, and material composition to the predicate devices listed in the table below.

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew, Inc.	Reflection 3 Acetabular System	K061253	5/31/06
Smith & Nephew, Inc.	Reflection XLPE Acetabular Liners	K002747	12/15/00
Smith & Nephew, Inc.	Reflection XLPE Acetabular Liners	K071160	10/5/07
Smith & Nephew, Inc.	R3 36mm XLPE Liners	K092386	11/3/09
Smith & Nephew, Inc.	R3 40 and 44mm XLPE Liners	K093363	1/26/10

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the R3 22-36mm XLPE Acetabular Liners. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate acetabular liners.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

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

APR 2 7 2012

Re: K113848

Trade/Device Name: R3 XLPE Acetabular Liners 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: MBL, MEH, LZO, JDI Dated: April 23, 2012 Received: April 24, 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 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

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Page 2 - Mr. John Connor

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,

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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Premarket Notification Indications for Use Statement

510(k) Number (if known):

R3 XLPE Acetabular Liners Device Name:

Indications for Use:

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, stipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

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)

Ashish

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

K113848 510(k) Number

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.