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 (NIDID) 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, atthritis 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 hin; and correction of deformity.

The R3 Acetabular System is for single use only and is intended for cementless use.

Device Description

The subject of this Special 510(k) is the R3® Anteverted Liners. The subject R3 Anteverted Liners are a line extension to the R3 XLPE Liners that were cleared under premarket notifications K113848 and K093363. The R3 Anteverted Liners have same overall design, indication for use and material as the predicate R3 XLPE liners.

The subject R3 Anteverted Liners feature a 20° anteverted, or "face changing", entry angle to the articulating surface (Inner diameter). Also, a variable angle chamfer/bevel was added on the rim of the liner. The R3 Anteverted Liners have +4mm lateralized inside Diameter, 20° andle, and identical locking mechanism as the predicate R3 XLPE Liners, cleared under K113848 and K093363.

The R3 Anteverted Liners are available with Inner diameter (ID) sizes 28, 32, 36, 40 and 44mm and the Outer Diameter (OD) sizes ranging from 44 to 76-80mm.The R3 Anteverted Liner is manufactured from 10MRAD Cross-linked Polyethylene (XLPE) confirming to ASTM F648, as the predicate R3 XLPE Liners cleared under a premarket notification K113848 and K093363. The R3 Anteverted Liners are provided sterile and is intended for single use only.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the R3 Anteverted Liners, demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for a novel AI/software component.

Therefore, many of the requested details about acceptance criteria, study design for AI, and expert involvement are not applicable to this document. The document focuses on demonstrating that the new device, a modification of an existing hip implant component, is just as safe and effective as previously cleared predicate devices through mechanical testing and comparison of characteristics.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not available or not applicable:

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

Since this is a submission for a physical medical device (hip implant liner) demonstrating substantial equivalence to predicate devices, the "acceptance criteria" are primarily related to safety and performance characteristics being equivalent or comparable, supported by mechanical bench testing. There isn't a table of discrete acceptance criteria with numerical targets and reported performance in the way one would see for an AI/software performance study.

The primary "acceptance criteria" is that the new R3 Anteverted Liners are substantially equivalent to the predicate R3 XLPE Liners and other referenced devices in terms of:

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	Identical to predicate
Indication for Use	Identical to predicate
Materials	Same material and manufacturing process as predicate (10MRAD Cross-linked Polyethylene (XLPE) confirming to ASTM F648)
Design Features	Overall same design features as predicate, with specific modifications: 20° anteverted entry angle, variable angle chamfer/bevel, +4mm lateralized inside Diameter, 20° angle, identical locking mechanism.
Sterilization	Provided sterile by Ethylene Oxide for single-use, same as predicate.
Mechanical Performance	Conducted non-clinical bench (mechanical) testing. A review of mechanical data and technical memo indicated substantial equivalence. Tests included: Push-in, Push-out, Lever-out, Torque to Failure, Finite Element Analysis, Range of Motion Analysis, Poly thickness comparison.
Biocompatibility	Testing completed.
Bacterial Endotoxin	Testing completed and met acceptable endotoxin limits per FDA Guidance and ANSI/AAMI ST72.

2. Sample size used for the test set and the data provenance

Sample size: Not explicitly stated for each mechanical test. The tests were performed on the R3 Anteverted Liners.
Data provenance: Not explicitly stated in terms of country of origin. The testing was "non-clinical bench (mechanical) testing" for a physical device manufactured by Smith & Nephew, Inc. It can be inferred to be prospective as it was performed to support the 510(k) submission for the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to this document. Ground truth as typically defined for AI/software (e.g., expert annotations on images) is not relevant to the mechanical testing of a physical hip implant liner. The "ground truth" for mechanical testing is established by engineering standards and validated testing procedures.

4. Adjudication method for the test set

This is not applicable to this document. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in image analysis or clinical assessments, which is not what this submission describes. The validity of the mechanical tests is based on adherence to recognized standards and engineering principles.

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 to this document. An MRMC study is for evaluating the performance of AI-assisted diagnostic tools. This document is for a physical orthopedic implant.

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

This is not applicable to this document. There is no AI algorithm involved in the R3 Anteverted Liners.

7. The type of ground truth used

The "ground truth" for the mechanical testing of the physical device is based on engineering standards and established testing methodologies to evaluate material properties and mechanical performance (e.g., strength, stability, wear characteristics) against predefined requirements derived from predicate device performance and regulatory standards.

8. The sample size for the training set

This is not applicable to this document. There is no AI algorithm with a training set.

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

This is not applicable to this document. There is no AI algorithm with a training set or ground truth establishment in this context.

Summary

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November 19, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

Smith & Nephew, Inc. Meenakshi Gupta Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K182535

Trade/Device Name: R3 Anteverted 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 Dated: October 23, 2018 Received: October 24, 2018

Dear Meenakshi Gupta:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 medical devices and radiation-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,

Daniel S. Ramsey -S 2018.11.19 16:51:55 -05'00'

For 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) K182535

Device Name R3 Anteverted Liners

Indications for Use (Describe)

The R3 Acetabular System is for single use only and is intended for cementless use.

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

Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
Date of Submission:	September 13, 2018
Contact Person:	Meenakshi Gupta, Sr. Regulatory Affairs SpecialistT (901) 399-6139F (901) 721-2748
Name of Device:	R3 Anteverted Liners
Common Name:	Acetabular Liners
Device Classification Nameand Reference:	21 CFR 888.3358 Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	MBL
Predicate Device:	Primary Predicate-R3 XLPE Liners-K113848Predicate 2-R3 XLPE Liners-K093363Predicate 3-REFLECTION Acetabular System-K920430Reference Predicate-R3 XLPE Anteverted Liners-K102370

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K182535

Device Description:

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, 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

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K182535

other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracturedislocation of the hip; and correction of deformity.

The R3 Acetabular System is for single use only and is intended for cementless use.

The above indication for use for the subject device, is identical to the R3 XLPE Liner cleared under K113848 and K093363, the REFLETION Acetabular System (K920430) and R3 XLPE Anteverted Liners (K102370).

Comparison of Technological Characteristics with the Predicate Device

Intended Use: The proposed R3 Anterverted Liners have identical Intended use as the predicate R3 XLPE Liners

Indication for Use: The proposed R3 Anterverted Liners have identical Indication for Use as the predicate R3 XLPE Liners

Materials: The proposed R3 Anterverted Liners are manufactured by same material and manufacturing process as the predicate R3 XLPE Liners

Design Features: The proposed R3 Anterverted Liners have overall same design features as the predicate R3 XLPE Liners.

Sterilization: The proposed R3 Anterverted Liners and predicate R3 XLPE Liners are provided sterile by Ethylene Oxide for single-use.

Therefore, the technological characteristics of the subject device are the similar to the technological characteristics of the predicate device R3 XLPE Liners cleared under K113848 and K093363.

Substantial Equivalence Information

The overall design, materials, and indications for use for R3 Anteverted Liners are substantially equivalent to the following commercially available predicate devices.

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Table: Predicate Devices

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew, Inc.	R3 XLPE Liner	K113848(Primary)	04/27/2012
Smith & Nephew, Inc.	R3 XLPE Liner	K093363	01/26/2010
Smith & Nephew, Inc.	Reflection Acetabular System	K920430	07/21/1992
Smith & Nephew, Inc.	R3 XLPE Anteverted Liners	K102370	01/19/2011

Performance Testing

To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing were conducted on the R3 Anteverted Liners. A review of the mechanical data and the technical memo, indicates that the R3 Anteverted Liners are substantially equivalent to predicate devices listed in the Table above. The following tests were used as a basis for the determination of substantial equivalence.

Push-in .
Push-out
Lever-out ●
Torque to Failure ●
Finite Element Analysis .
Range of Motion Analysis ●
Poly thickness comparison .
o Biocompatibility

Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.

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K182535

Conclusion

As previously noted, this special 510(k) Premarket Notification is being submitted to request clearance for the R3 Anteverted Liners. Based on the similarities to the predicate devices and a review of the mechanical testing performed, the subject device is substantially equivalent to the commercially available predicate devices listed above.

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.