The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.

Device Description

The R3 Constrained Liners were previously cleared for market via premarket notification K111635. Subject of this premarket notification are minor modifications to the R3 Constrained Liner components, specifically the bipolar shell and inner poly liner.

The R3 Constrained Liners are available with inner diameters of 22 and 28mm and outer diameters from 52mm through 66/70mm. The devices are assembled from components that are made of ASTM F75 CoCr, ASTM F90 CoCr, ASTM F1472 Ti-6AI-4V, and ASTM F648 UHMWPE.

AI/ML Overview

The provided 510(k) summary (K122139) for the Smith & Nephew R3 Constrained Liner describes modifications to an existing device, not an AI/ML-driven device. Therefore, the information requested regarding acceptance criteria, study details, and ground truth establishment, which are typical for AI/ML device evaluations, is not present in this document.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing, rather than clinical performance studies.

Here's a breakdown of what is available in the document in relation to your request, and what is not:

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

Acceptance Criteria: The document mentions that "Mechanical testing has been conducted to address the attachment loads (push-in, push-out, shuck-out) of the R3 Constrained Liner components as well as to address simulated intraoperative dislocation." The implicit acceptance criterion is that the new device's performance in these mechanical tests demonstrates equivalence to the legally marketed predicate devices.
Reported Device Performance: The summary states: "A review of the results indicates that the R3 Constrained Liners are equivalent to existing, legally marketed predicate devices with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices." Specific numerical performance data from these mechanical tests are not provided in this summary.

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

Not Applicable/Not Provided: Since this is a mechanical testing study on device components, there is no "test set" in the traditional sense of patient data. The "sample size" would refer to the number of physical device components tested, which is not specified in this summary. Data provenance (country of origin, retrospective/prospective) is also not applicable for mechanical testing.

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

Not Applicable: This type of expert assessment is relevant for clinical studies or image interpretation, not mechanical testing of physical implants. The "ground truth" for mechanical tests would be defined by engineering standards and test protocols.

4. Adjudication method for the test set:

Not Applicable: Adjudication is typically used in clinical studies involving interpretation or outcome assessment.

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:

No: This is explicitly for AI/ML devices with human-in-the-loop components. This device is a physical hip implant component.

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

No: See point 5.

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

Mechanical Standards/Engineering Specifications: For mechanical testing, the "ground truth" is established by adherence to recognized engineering standards (e.g., ASTM standards for material properties and test methods) and comparison against the performance of predicate devices as per their design specifications and previous testing.

8. The sample size for the training set:

Not Applicable/No Training Set: This device does not involve machine learning, so there is no training set.

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

Not Applicable/No Training Set: See point 8.

In summary of the provided text:

The device (R3 Constrained Liner) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices. This was achieved through mechanical testing that assessed attachment loads (push-in, push-out, shuck-out) and simulated intraoperative dislocation. The "acceptance criteria" were met by showing that the modified R3 Constrained Liners performed equivalently to the predicate devices in these mechanical tests, suggesting no new safety or effectiveness concerns. Specific quantitative results of these mechanical tests are not detailed in this summary. No clinical data or AI/ML performance studies were performed or required.

Summary

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510K
Summary

K122139 (pg 1/2)

> We are smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	October 12, 2012
Contact Person and Address:	Martin OstmannRegulatory Affairs SpecialistT (901) 399-1809F (901) 566-7086
Name of Device:	Smith & Nephew, Inc. R3 Constrained Liner
Common Name:	Acetabular Liner, Constrained
Device Classification Name andReference:	21 CFR 888.3310 Hip joint metal/polymer constrainedcemented or uncemented prosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	KWZ

OCT 1 6 2012#### Device Description

Technological Characteristics

Mechanical testing has been conducted to address the attachment loads (push-in, push-out, shuck-out) of the R3 Constrained Liner components as well as to address simulated intraoperative dislocation. A review of the results indicates that the R3 Constrained Liners are equivalent to existing, legally marketed predicate devices with regards to mechanical performance and 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

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Substantial Equivalence Information

The subject devices are identical in function, intended use, indications for use, and material composition, and very similar in overall design to the R3 Constrained Liners cleared via premarket notification K111635.

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	R3 Constrained Liner	K111635	9/9/2011
Smith & Nephew,Inc.	Reflection Constrained Liners	K021803 K033442	12/19/200211/26/2003
Depuy, A J&JCompany	S-Rom Constrained Liner	P960054	6/19/1997

Table 1: Substantially equivalent predicates to the R3 Constrained Liner

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the modified R3 Constrained 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 constrained hip systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are 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

OCT 16 2012

Smith and Nephew, Incorporated % Mr. Martin Ostmann Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116

Re: K122139

Trade/Device Name: R3 Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: KWZ

Dated: July 17, 2012 Received: July 19, 2012

Dear Mr. Ostmann:

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

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Page 2 - Mr. Martin Ostmann

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,

yours,
For
Melkerson

Mark N. Melkersoi 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): K122139 (pg 1/1)

R3 Constrained Liner Device Name:

Indications for Use:

Prescription Use × (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)

K Asmali

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

510(k) Number K122139

Page 1 of

4-1

Regulation Number and Section

§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”