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.

Device Description

The R3 HA Coated Acetabular Shells are line additions to the existing R3 Acetabular System. The R3 HA Coated Acetabular Shells have the same design as the existing R3 Shells. The difference is the addition of HA coating. The R3 Ha Coated Acetabular Shells will be offered in No-Hole, 3-Hole and Multi-Hole design options. The R3 HA Coated Acetabular Shells will be used with existing R3 Acetabular Liners and accessories and existing Smith & Nephew femoral heads and femoral stems.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Based on the provided FDA 510(k) summary for the "R3 HA Coated Acetabular Shells," there is no specific information on acceptance criteria for a device performance study or any human-in-the-loop or standalone AI performance studies.

This document is a 510(k) clearance for a hip implant, which typically focuses on demonstrating substantial equivalence to a predicate device rather than complex AI performance metrics. The clearance is for a medical device (hip implant), not a software or AI-driven diagnostic/treatment device.

Therefore, many of the requested categories for AI-related studies (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and AI training set details) are not applicable to this document.

Here's a breakdown of what can be extracted from the document, tailored as much as possible to your request, but highlighting the absence of AI-specific performance criteria:

Acceptance Criteria and Study for R3 HA Coated Acetabular Shells

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance
Mechanical Performance	The locking mechanism should perform as intended and meet applicable requirements to ensure safety and effectiveness when used with existing R3 Acetabular Liners and accessories. The overall mechanical characteristics should be substantially equivalent to predicate devices.	The document states: "The locking mechanism is the same as for the predicate R3 acetabular shell. Therefore, all testing previously conducted confirmed that the device should perform as intended." This implies that the device did perform as intended, meeting established mechanical performance benchmarks derived from the predicate device's prior successful testing.
Coating Performance	StikTite coating and hydroxyapatite (HA) coating must meet applicable FDA guidance requirements. This would include aspects like adhesion, biocompatibility, and perhaps dissolution rates for HA.	The document states: "Testing conducted on the StikTite coating and hydroxyapatite according to FDA guidance confirmed that the coatings met applicable requirements." This directly confirms that the coating performance met the specified regulatory standards and guidance, indicating successful testing outcomes.
Biocompatibility	Materials used (including coatings) must be biocompatible and raise no new questions of safety or effectiveness compared to predicate devices.	The document states: "The R3 HA Coated Acetabular Shells are manufactured from the same materials as the listed predicates." and "The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness." This implicitly confirms biocompatibility through comparison to already cleared predicate devices using the same materials, suggesting the materials meet established biocompatibility norms.
Indications for Use	The device's intended use should align with the predicate devices and be appropriate for primary and revision surgery in cases of trauma, NIDJD, inflammatory degenerative joint disease, and various fracture/deformity corrections.	The Indications for Use section is identical to general indications for hip components, and the comparison section explicitly states, "The R3 HA Coated Acetabular Shells are technologically substantially equivalent to predicate devices in terms of intended use..." This confirms that the device is deemed appropriate for the stated indications, having met the implicit criteria of comparable intended use and safety/effectiveness for those indications.
"No New Questions"	The materials, design, mechanical performance, and safety of the R3 HA Coated Acetabular Shells should not raise any new questions of safety or effectiveness compared to the predicate devices.	The conclusion states: "The R3 HA Coated Acetabular Shells are technologically substantially equivalent to predicate devices in terms of intended use, material, design, mechanical performance and safety." and "any differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate device." This is the ultimate acceptance criterion for 510(k) clearance and was met.

Summary of the Study Proving Acceptance Criteria were Met:

The study proving the device met the acceptance criteria was a non-clinical performance testing effort, specifically focusing on mechanical testing of the locking mechanism and coating evaluation for both StikTite and hydroxyapatite. This testing was conducted according to FDA guidance. The central argument for substantial equivalence relies on the fact that the R3 HA Coated Acetabular Shells share the same design (other than the HA coating), materials (with the addition of HA), and locking mechanism as already cleared predicate devices.

Regarding AI-Specific Information (Not Applicable to this Document):

The following points are not addressed in the provided 510(k) summary because this document pertains to a physical medical implant, not an AI software component or an AI-assisted diagnostic/treatment system.

Sample size used for the test set and the data provenance: Not applicable. (No AI test set described)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (No AI ground truth described)
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. (No AI test set described)
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 AI component to evaluate)
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. (No AI component to evaluate)
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. (No AI ground truth described)
The sample size for the training set: Not applicable. (No AI training set described)
How the ground truth for the training set was established: Not applicable. (No AI ground truth described)

In conclusion, this document demonstrates that the R3 HA Coated Acetabular Shells met the acceptance criteria for a 510(k) clearance by proving substantial equivalence to predicate devices through non-clinical mechanical and coating performance testing, consistent with FDA guidance. It does not involve any AI components or related performance studies.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 6, 2020

Smith & Nephew, Inc. John Reabe Director, Regulatory Affairs 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K201701

Trade/Device Name: R3 HA Coated Acetabular Shells 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, LZO, LPH, JDI, MEH, LWJ Dated: September 3, 2020 Received: September 4, 2020

Dear John Reabe:

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

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

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K201701

Device Name R3 HA Coated Acetabular Shells

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

K201701 510(k) Summary R3 HA Coated Acetabular Shells

I. Submitter

Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016

Contact Person: John Reabe Director Email: john.reabe@smith-nephew.com Phone: 901-399-6670

Date of Summary: October 1, 2020

II: Device

Proprietary Name:	R3 HA Coated Acetabular Shells
Common Name:	Artificial Hip Prosthesis
Regulatory Class:	Class II
Regulation:	21 CFR Section 888.3358 Hip joint metal/polymer/metalsemi-constrained porous-coated uncemented prosthesis
Device Product Codes:	MBL, LZO, LPH, JDI, MEH, LWJ
Panel:	Orthopedic

III. Predicate Devices

Device	Manufacturer	510(k) No.	Clearance Date
Primary Predicate
Reflection 3 Acetabular System	Smith & Nephew	K060630 K061253 K070756 K092386	06/14/200605/31/200606/06/200711/03/2009
Predicates
Hip Systems with HA includingReflection Shells with HA	Smith & Nephew	K090982	04/21/2010

IV. Device Description

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

K201701 510(k) Summary R3 HA Coated Acetabular Shells

Shells will be offered in No-Hole, 3-Hole and Multi-Hole design options. The R3 Ha Coated Acetabular Shells will be used with existing R3 Acetabular Liners and accessories and existing Smith & Nephew femoral heads and femoral stems.

V. Indications for Use

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; fracturedislocation of the hip; and correction of deformity.

VI. Comparison of Technological Characteristics with the Predicate Devices

The R3 HA Coated Acetabular Shells are technologically substantially equivalent to predicate devices in terms of intended use, material, design, mechanical performance and safety. The R3 HA Coated Acetabular Shells are manufactured from the same materials as the listed predicates. The shells are available in sizes with the same outer diameter. The locking mechanism is the same as for the predicate R3 Acetabular Shells. The R3 HA Coated Acetabular Shells are used with the same acetabular inserts that are used with the predicate R3 Acetabular Shells. Lastly, the asymmetric StikTite porous coating is the same as for the predicate Reflection 3 Acetabular Shells and the HA coating is the same as for the predicate Reflection Shells with HA.

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness.

{5}------------------------------------------------

K201701 510(k) Summary R3 HA Coated Acetabular Shells

VII. Performance Data

The locking mechanism is the same as for the predicate R3 acetabular shell. Therefore, all testing previously conducted confirmed that the device should perform as intended. Testing conducted on the StikTite coating and hydroxyapatite according to FDA guidance confirmed that the coatings met applicable requirements.

Clinical data was not necessary to support a decision of substantial equivalence.

VIII. Conclusions

A review of the device indications, material composition, shell design, and technological characteristics confirmed that the R3 HA Coated Acetabular Shells are substantially equivalent to the predicate devices. While the R3 HA Coated Acetabular Shells are not identical to the predicate devices, comparisons of the subject and predicate devices confirmed that any differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate device. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices. Therefore, it is concluded that the R3 HA Coated Acetabular Shells are substantially equivalent to the predicate devices.

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.