The Smith & Nephew, Inc. Journey Select Knee System is intended to be used for those patients whereby conditions exist that may not be solely addressed by a device that treats a single compartment. The Journey Select Knee System is intended to replace the patellofemoral and either the medial or lateral condyle of the knee joint in patients where there is evidence of sufficient sound bone to seat and support the components. Indications include:

Post-traumatic arthritis;
Degenerative arthritis; and
Failed osteotomies and unicompartmental replacement.
These indications will be used for the Journey Select Knee System, whereby a single condyle and patellofemoral regions of the knee have been affected by one or more of these conditions. The implant devices of the Smith & Nephew, Inc. Journey Select Knee System are single use only and are intended for implantation only with bone cement.

Device Description

The Smith & Nephew, Inc. Journey Select Knee System is composed of existing unicompartmental femoral components, patellofemoral implant components, and unicompartmental tibial components previously cleared by FDA. These components may be used in various combinations to create a bicompartmental knee replacement prosthesis and allow the physician to choose the most appropriate option to treat the patient.

AI/ML Overview

This document is a 510(k) premarket notification for the "Smith & Nephew, Inc. JOURNEY Select Knee System." It is a submission for a medical device that aims to demonstrate substantial equivalence to previously cleared devices, rather than establishing acceptance criteria and proving performance through a study in the same way one would for a novel device with a new intended use.

Here's an analysis based on the provided text, addressing your questions to the best of my ability given the nature of a 510(k) summary:

The core of this document is a claim of "Substantial Equivalence," not a study proving the device meets specific performance acceptance criteria via a clinical trial or algorithm performance study. The device is a combination of existing components already cleared by the FDA.

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and the results of a performance study proving adherence to them are not explicitly detailed in the provided text in the manner you might expect for a novel device. Instead, the "performance" is demonstrated through substantial equivalence to predicate devices and mechanical testing.

Acceptance Criteria (Implied by 510(k) pathway)	Reported Device Performance
Material Equivalence: Components are existing, FDA-cleared parts.	The individual implant devices in the Smith & Nephew, Inc. Journey Select Knee System are existing devices previously cleared by FDA for unicompartmental knee replacement.
Mechanical Performance: Capable of withstanding expected in vivo loading without failure.	"A review of the mechanical testing results indicated that the implant components... are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."
Indications for Use Equivalence: Similar indications to predicate devices.	The Indications for Use for the Journey Select Knee System are provided and implied to be consistent with those of the predicate devices.
Safety and Effectiveness Equivalence: The device is as safe and effective as predicate devices.	The FDA letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate "acceptance."

Regarding Questions 2-7, 8, 9, these types of studies and details are generally not part of a 510(k) submission for substantial equivalence based on mechanical testing and existing components.

No clinical study to establish these points was conducted for this 510(k) submission. The entire premise of a 510(k) is to demonstrate that a new device is as safe and effective as an already legally marketed device (the predicate).

Specifically:

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

Not applicable for this type of 510(k) submission, as it relies on mechanical testing of components and equivalence to existing devices, not a clinical "test set" of patient data.

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 as typically defined for diagnostic or prognostic devices (e.g., expert interpretation of images) is not relevant here. The ground truth for this device's safety and effectiveness is established by the prior FDA clearances of its individual components and the predicate devices.

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

Not applicable. No clinical test set with adjudicated outcomes or diagnoses was described.

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 device is a knee prosthesis system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a knee prosthesis system, not an algorithm.

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

The "ground truth" in the context of this 510(k) is effectively the prior FDA clearance and established safety/effectiveness profiles of the individual components and the predicate devices. Mechanical testing also serves as an engineering "ground truth" for the device's physical capabilities.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) for a knee prosthesis system.

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

Not applicable.

In summary: The provided document is a 510(k) premarket notification for a new combination of existing, cleared components for a knee prosthesis system. The "proof" it meets acceptance criteria (primarily safety and effectiveness) is primarily through demonstrating substantial equivalence to predicate devices that are already legally marketed and through mechanical testing showing the integrated system can withstand expected in-vivo loads. It does not involve a clinical efficacy study with patient data, expert ground truth, or AI performance metrics as would be seen for a diagnostic or prognostic device or a novel therapeutic with new mechanism of action.

Summary

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Summary of Safety and Effectiveness Smith & Nephew, Inc. JOURNEY® Select Knee System

Date of Summary: September 28, 2009

Contact Person and Address Jason Sells Manager, Regulatory Affairs Smith & Nephew. Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 T (901) 399-5520

DEC 1 5 2009

KD9305

Name of Device: Smith & Nephew, Inc. JOURNEY Select Knee System Common Name: Knee Prosthesis Components

Device Classification Name and Reference: 21 CFR 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis; 21 CFR 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis; 21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Device Class: Class II Panel Code: Orthopaedics 87/ HSX, KRR, and NPJ

Device Description

Mechanical Testing

A review of the mechanical testing results indicated that the implant components of the Smith & Nephew, Inc. Journey Select Knee System are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.

Intended Use

Post-traumatic arthritis; 1.
1. Degenerative arthritis; and
1. Failed osteotomies and unicompartmental replacement.

These indications will be used for the Journey Select Knee System, whereby a single condyle and patellofemoral regions of the knee have been affected by one or more of these conditions. The implant devices of the Smith & Nephew, Inc. Journey Select Knee System are single use only and are intended for implantation only with bone cement.

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Substantial Equivalence Information

The individual implant devices in the Smith & Nephew, Inc. Journey Select Knee System are existing devices previously cleared by FDA for unicompartmental knee replacement. The Journey Select Knee System is substantially equivalent to the following compartmental knee systems:

K093056

Howmedica Osteonics Stryker® Compartmental Knee System, K052917 ■
Howmedica Osteonics Stryker® Compartmental Knee System Line Extension, K082567 I
이 DePuy Orthopaedics Graduated Compartmental Knee (GCK), K061648
DePuy GCK Femoral and Tibial Components, K070849 ■
DePuy GCK Femoral and Tibial Components, K070267 l

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 1 5 2009

Smith & Nephew, Inc. % Mr. Jason Sells 1450 Brooks Road Memphis, Tennessee 38116

Re: K093056

Trade/Device Name: Smith & Nephew, Inc. Journey Select Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: NPJ, HSX, KRR Dated: September 28, 2009 Received: September 30, 2009

Dear Mr. Sells:

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.

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

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Page 2 - Mr. Jason Sells

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Omita D

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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Indications for Use

510(k) Number (if known):

Device Name: Smith & Nephew, Inc. JOURNEY Select Knee System

Indications for Use:

The Smith & Nephew, Inc. Journey Select Knee System is intended to be used for those patients whereby conditions exist that may not be solely addressed by a device that treats a single · compartment. The Journey Select Knee System is intended to replace the patellofemoral and either the medial or lateral condyle of the knee joint in patients where there is evidence of sufficient sound bone to seat and support the components. Indications include

1. Post-traumatic arthritis;
1. Degenerative arthritis; and
Failed osteotomies and unicompartmental replacement. 3.

AND/OR Over-The-Counter Use × Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jonuta for mxm
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of

510(k) Number K093056

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.