Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

Device Description

Subject of this Traditional Premarket Notification are the Journey II XR Knee system. The subject device is a bi-cruciate retaining total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include the following components:

. Medial and lateral cross-linked polyethylene articular inserts which will be available in left and right hand
o Titanium alloy (Ti-6Al-4V) tibial bases which will be available in left and right hand
The Journey II XR Knee system will use existing Journey II CR femoral components and existing patella components compatible with the Journey II CR femoral as well as device specific instruments.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Journey II XR Knee System, which is a medical device (a knee prosthesis). This type of document focuses on establishing substantial equivalence to existing legally marketed devices, rather than a robust clinical study proving performance against specific acceptance criteria for a new AI/software device.

A 510(k) summary for a traditional medical device like a knee implant focuses on demonstrating that the new device is as safe and effective as a predicate device, primarily through comparing technological characteristics and mechanical testing. It does not involve the kind of clinical study with human readers, ground truth establishment, or performance metrics (like sensitivity, specificity, AUC) that would be conducted for an AI/software as a medical device (SaMD).

Therefore, based on the provided document, the following points apply:

A table of acceptance criteria and the reported device performance: Not applicable in the context of this 510(k) submission for a knee implant. The "performance" is demonstrated through mechanical testing and comparison to predicates.

Acceptance Criteria (Implied by 510(k) for mechanical qualities)	Reported Device Performance (Mechanical Testing)
Withstand expected in vivo loading without failure	* Tibiofemoral Contact Area Analysis
	* Tibiofemoral Constraint Testing
	* Construct Fatigue Strength Testing
	* Static testing of the insert locking mechanism
	* Tibial base plate fatigue performance
No new issues related to safety and effectiveness	Testing demonstrated no new issues.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. "Clinical data was not needed to support the safety and effectiveness of the subject devices" (page 3). The testing was mechanical, not clinical.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/software in a clinical context (e.g., expert consensus on image interpretation) is not relevant to this mechanical device submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI/software device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical testing, the "ground truth" would be the engineering specifications and established test methodologies for evaluating the structural integrity and functional characteristics of knee implants. This is not the same as clinical ground truth.
The sample size for the training set: Not applicable, as this is not an AI/software device with a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for a traditional metallic and polymeric knee prosthesis, not an AI/software device. The demonstration of safety and effectiveness relies on mechanical testing and comparison to predicate devices, not on clinical studies involving human readers or AI algorithm performance metrics.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of a human face in profile, with three overlapping faces creating a sense of depth and dimension. The faces are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

November 14, 2014

Smith and Nephew, Incorporated Ms. Shereen Bienz Senior Regulatory Affairs Specialist 7135 Goodlet Farm Parkway Cordova, Tennessee 38018

Re: K141471 Trade/Device Name: Journey II XR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Regulatory Class: Class II Product Code: JWH Dated: October 16, 2014 Received: October 17, 2014

Dear Ms. Bienz:

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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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic 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): K141471

Device Name: Journey II XR Knee System

Indications for Use:

The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _ 1

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Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew" in gray and orange. The words "We are" are in gray, while "smith&nephew" is in orange.

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	November 12, 2014
Contact Person and Address:	Shereen BienzSenior Regulatory Affairs SpecialistT (901) 399-6325F (901) 566-7075
Name of Device:	Smith & Nephew, Inc. Journey II XR Knee System
Common Name:	Knee Prosthesis
Device Classification Name andReference:	21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	JWH

Device Description

. Medial and lateral cross-linked polyethylene articular inserts which will be available in left and right hand
o Titanium alloy (Ti-6Al-4V) tibial bases which will be available in left and right hand

The Journey II XR Knee system will use existing Journey II CR femoral components and existing patella components compatible with the Journey II CR femoral as well as device specific instruments.

Technological Characteristics

A review of the mechanical data indicates that the Journey II XR Knee System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Journey II XR Knee system was performed:

Tibiofemoral Contact Area Analysis
Tibiofemoral Constraint Testing
Construct Fatigue Strength Testing ●
Static testing of the insert locking mechanism
Tibial base plate fatigue performance ●

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

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Intended Use

Substantial Equivalence Information

The substantial equivalence of the Journey II XR Knee system is based on its similarities in indications for use, design features, and operational principles to the predicate systems listed in the following table.

Design AspectReviewed	Journey II XRKnee System	Townley TotalKnee (BioPro)	Journey II CR	Genesis II CR	Genesis II HighFlex Inserts
510(k) Number	Subject 510(k)	K904448	K121443	K951987	K041825
Manufacturer	Smith &Nephew, Inc.	BioPro, Inc	Smith &Nephew, Inc.	Smith &Nephew, Inc.	Smith &Nephew, Inc.
SimilarIndications forUse	Yes	Yes	Yes	Yes	Yes
SimilarSterilizationMethods	Yes	Yes	Yes	Yes	Yes
Bi-cruciateretaining	Yes	Yes	No	No	No
Insert material	XLPE	UHMWPE	XLPE andUHMWPE	UHMWPE	UHMWPE
SimilarLockingMechanism	Yes	Yes	Yes	Yes	Yes
Tibial basematerial	Ti-6Al-4V	Ti-6Al-4V	Ti-6Al-4V	Ti-6Al-4V	Ti-6Al-4V
SimilarManufacturingProcess	Yes	Unknown	Yes	Yes	Yes

Table 1: Comparison to Substantially Equivalent Devices

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Journey II XR Knee System. Based on the similarities to the predicate components and a review of the validation testing performed, the device is substantially equivalent to above predicate systems.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.