Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

Device Description

Subject of this Abbreviated Premarket Notification is the Journey II BCS Knee system. The Journey II BCS Knee System is a posterior stabilized total knee system which provides the ability for greater flexion (155°) to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include:

Posterior stabilized femoral components which will initially be available in sizes 1-10 in right . and left designs in OXINIUM material.
Posterior stabilized femoral components which will initially be available in sizes 1-9 in right . and left designs in cobalt chrome material
Posterior stabilized articular inserts which will initially be available in sizes 1-2, 3-4, 5-6, and . 7-8 in right and left designs. Journey II BCS articular inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene (XLPE) material and conventional non-cross-linked Ultra-High Molecular Weight Polyethylene (UHMWPE) material.
The Journey II BCS Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515) and may also be used with existing patellar components of the Genesis II Knee System (K951987).

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device, the Journey II BCS Knee System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with a full-fledged acceptance criteria and performance study as might be done for a novel device.

Therefore, many of the typical questions regarding acceptance criteria, study design, expert ground truth, and training sets from an AI/imaging device perspective are not applicable to this document. The "study" here refers to mechanical testing for equivalence, not a clinical trial or AI model validation.

Here's a breakdown based on the information provided and addressing the non-applicability:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Mechanical Testing)	Reported Device Performance
Withstanding expected in vivo loading without failure, as demonstrated by:	A review of the mechanical data indicates that the Journey II BCS Knee System is capable of withstanding expected in vivo loading without failure.
Patellofemoral Contact Area Analysis	Testing performed. Specific results are not detailed, but overall conclusion is positive.
Tibiofemoral Contact Area Analysis	Testing performed. Specific results are not detailed, but overall conclusion is positive.
Static Testing of the Tibial Insert Locking Mechanism	Testing performed. Specific results are not detailed, but overall conclusion is positive.
Patellofemoral Resistance to Lateral Subluxation	Testing performed. Specific results are not detailed, but overall conclusion is positive.
Tibiofemoral Constraint Testing	Testing performed. Specific results are not detailed, but overall conclusion is positive.
No new issues related to the safety and effectiveness compared to predicate devices.	A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices.
Substantial equivalence to predicate devices based on:	The substantial equivalence of the Journey II BCS Knee system is based on its similarities in indications for use, design features, and operational principles to the predicate systems listed. `[K042515](https://510k.innolitics.com/search/K042515)`, `[K073325](https://510k.innolitics.com/search/K073325)`, `[K071071](https://510k.innolitics.com/search/K071071)`, `[K951987](https://510k.innolitics.com/search/K951987)`, `[K032295](https://510k.innolitics.com/search/K032295)`, `[K091014](https://510k.innolitics.com/search/K091014)`

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

Sample Size: Not applicable in the context of clinical data for this 510(k) submission. The "test set" here refers to mechanical testing of device components. The document does not specify the number of components tested for each mechanical analysis, but it's not a human patient "test set."
Data Provenance: Not applicable for clinical data. The mechanical testing would have been performed in a laboratory setting.

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. Ground truth in this context is established through engineering and mechanical testing standards and comparison to predicate devices, not expert human interpretation of data for diagnostic purposes.

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

Not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies involving human interpretation or uncertain outcomes. Mechanical testing relies on measurable physical properties and engineering standards.

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. This document is for a knee prosthesis, a physical implant. It does not involve AI or human readers for diagnostic interpretation. The submission explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance demonstration is based on mechanical engineering principles and standards, comparison to predicate device performance, and the absence of new safety/effectiveness issues revealed by those mechanical tests.

8. The sample size for the training set

Not applicable. This is a physical medical device; there is no "training set" in the context of an AI/machine learning model.

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

Not applicable. As there is no training set for an AI model, this question is not relevant.

Summary

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KIIII7II *キりね

re smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	June 17, 2011
Contact Person and Address:	Shereen Myers, Senior Regulatory Affairs SpecialistT (901) 399-6325 F (901) 566-7075
Name of Device:	Smith & Nephew, Inc Journey II BCS 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

Posterior stabilized femoral components which will initially be available in sizes 1-10 in right . and left designs in OXINIUM material.
Posterior stabilized femoral components which will initially be available in sizes 1-9 in right . and left designs in cobalt chrome material
Posterior stabilized articular inserts which will initially be available in sizes 1-2, 3-4, 5-6, and . 7-8 in right and left designs. Journey II BCS articular inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene (XLPE) material and conventional non-cross-linked Ultra-High Molecular Weight Polyethylene (UHMWPE) material.

The Journey II BCS Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515) and may also be used with existing patellar components of the Genesis II Knee System (K951987).

Technological Characteristics

This 510(k) was prepared in accordance with the Agency's, "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses," dated April 1993. A review of the mechanical data indicates that the Journey II BCS Knee System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Journey II BCS Knee system was performed:

. Patellofemoral Contact Area Analysis
Tibiofemoral Contact Area Analysis .
Static Testing of the Tibial Insert Locking Mechanism

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K111711 *2/

Patellofemoral Resistance to Lateral Subluxation
Tibiofemoral Constraint Testing .

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

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

Substantial Equivalence Information

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

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew, Inc	High Performance Knee System	K042515	03/14/2005
Smith & Nephew, Inc	Legion Porous Primary KneeSystem	K073325	12/20/2007
Smith & Nephew, Inc	XLPE Articular Inserts	K071071	09/19/2007
Smith & Nephew, Inc	Genesis II Total Knee System	K951987	08/22/1995
Smith & Nephew, Inc	Genesis II Posterior Stabilized HighFlexion Articular Insert	K032295	08/21/2003
Smith & Nephew, Inc	Journey BCS Knee System	K091014	09/29/2009

Table 1: Substantially equivalent predicate devices

Conclusion

As previously noted, this Abbreviated 510(k) Premarket Notification is being submitted to request clearance for the Journey II BCS Knee System. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate knee systems.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

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

Smith & Nephew. Inc. % Ms. Shereen Myers Senior Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116

SEP 1 6 2011

Re: K111711

Trade/Device Name: Journey II BCS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: June 17, 2011 Received: June 20, 2011

Dear Ms. Myers:

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 (IMA), 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 - Ms. Shereen Myers

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 331-542 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely vours

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Journey II BCS Knee System

Indications for Use:

× × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × Prescription Use

AND/OR

(Part 21 CFR 801 Subpart D)

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)

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

510(k) Number L 111711

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.