Journey II XR Instruments are accessory devices and intended to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared indication for use.

Total knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.

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

Device Description

The subject of this Traditional 510(k) is a design modification (i.e. tip geometry) to the Journey II XR Tibial Posterior Keel Punch. The Journey II XR Tibial Posterior Keel Punch are reusable instrument and are intended to be used to prepare for the posterior keel of the tibia baseplate implant and act as a guide for the Anterior Keel Punch. The Journey II XR Keel Punch were previously cleared for market notification K173331.

The Journey II XR Keel Punch are available in same size range as the predicate.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a design modification to the Journey II XR Knee Instrument, specifically the Tibial Posterior Keel Punch. This document does not describe a study involving AI or human readers. Instead, it outlines a traditional medical device clearance process focused on demonstrating substantial equivalence to a predicate device through non-clinical bench testing.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set information) are not applicable or cannot be extracted from this document, as they pertain to clinical or AI-based performance studies, which were not conducted or described here.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (as demonstrated by)
Device performs as intended (mechanical integrity and function).	Finite Element Analysis (FEA)
No new issues related to safety and effectiveness compared to predicate.	Stress Distribution Test
Substantially equivalent to predicate device in design, material, and performance.	Review of mechanical data and technical memo indicated substantial equivalence.

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

Sample size: Not specified. The document refers to "non-clinical bench (mechanical) testing" and "review of the mechanical data," but does not provide specific sample sizes for these tests (e.g., number of punches tested).
Data Provenance: Not specified, but implied to be from internal lab testing ("bench testing") conducted by Smith & Nephew, Inc.

3. 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 clinical performance or AI evaluation (e.g., expert consensus on medical images) is not relevant for this type of mechanical device testing. The "ground truth" here is adherence to mechanical engineering principles and performance specifications.

4. Adjudication method for the test set

Not applicable. No clinical adjudication method was used. The evaluation centered on engineering analysis and test results.

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. An MRMC comparative effectiveness study was not done, as this document describes the clearance of a mechanical surgical instrument, not an AI-assisted diagnostic or therapeutic device.

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

No. This document does not describe a standalone algorithm or AI performance study.

7. The type of ground truth used

For mechanical device testing, the "ground truth" is typically defined by engineering specifications, design requirements, and a comparison to the established performance of the predicate device, as demonstrated through the specified testing (Finite Element Analysis, Stress Distribution Test).

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI model. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set, there is no ground truth for a training set.

Summary

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June 4, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Smith & Nephew, Inc. Brad Sheals, MS Senior Regulatory Affairs Specialist Advanced Surgical Devices Division 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K200227

Trade/Device Name: Journey II XR Knee Instrument Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: May 11, 2020 Received: May 12, 2020

Dear Brad Sheals:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

for Ting Song, Ph.D., R.A.C. Acting 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

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Indications for Use

510(k) Number (if known) K200227

Device Name JOURNEY II XR Knee Instruments

Indications for Use (Describe)

Journey II XR Instruments are accessory devices and intended to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared indication for use.

Total knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.

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

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)

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Image /page/3/Picture/1 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" in gray, and "smith&nephew" in orange. The text is aligned horizontally, creating a clean and professional look.

Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
Date of Submission:	June 3, 2020
Contact Person:	Brad Sheals, Regulatory Affairs ManagerT (901) 399-6897F (901) 566-7911
Name of Device:	Journey II XR Knee Instrument
Common Name:	Knee Instrument
Device Classification Nameand Reference:	21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	JWH
Predicate Device:	Smith & Nephew, Inc. Journey II XR Knee SystemInstruments - K173331

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Image /page/4/Picture/1 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". The words "We are" are in gray, while "smith&nephew" is in orange.

Device Description:

The Journey II XR Keel Punch are available in same size range as the predicate.

Indication for Use:

Journey II XR Instruments are accessory devices and intended to be used to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared indication for use.

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.

The above indications are substantially equivalent to the indications cleared for the Smith & Nephew, Inc. Journey II XR Knee System Instruments cleared under K173331. The Smith & Nephew Journey II XR Total Knee systems were cleared under K141471 and K152726.

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Image /page/5/Picture/1 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". The words "We are" are in gray, while "smith&nephew" is in orange.

Technological Characteristics

Device comparisons described in this premarket notification demonstrate that the subject device Journey II XR Keel Punch are substantially equivalent to the below listed legally marketed predicate devices with regard to intended use, indications for use, design, material and performance characteristics.

Substantial Equivalence Information

As confirmed in the table below, the overall design, indications for use and sterilization for the subject Journey II XR Keel Punch is substantially equivalent to the following commercially available predicate device.

DesignFeatures	Subject Journey II XR TibialPosterior Keel Punch	Predicate Journey II XR TibialPosterior Keel Punch
Manufacturer	Smith & Nephew, Inc.	Smith & Nephew, IncK173331 SE 11/16/2017
Indication forUse	Journey II XR Instruments areaccessory devices and intended to beused to assist in the implantation ofSmith & Nephew Journey II XR Kneesystems and their cleared indicationfor use	Journey II XR Instruments areaccessory devices and intended to beused to assist in the implantation ofSmith & Nephew Journey II XR Kneesystems and their cleared indication foruse
	Total knee components are indicatedfor rheumatoid arthritis; post-traumaticarthritis, osteoarthritis, or degenerativearthritis;failed osteotomies,unicompartmental replacement,ortotal knee replacement.	Total knee components are indicatedfor rheumatoid arthritis; post-traumaticarthritis, osteoarthritis, or degenerativearthritis;failed osteotomies,unicompartmental replacement, or totalknee replacement.
	The Journey II Total Knee systemcomponents are indicated for use onlywith cement and are single usedevices.	The Journey II Total Knee systemcomponents are indicated for use onlywith cement and are single use devices.
Material	Stainless Steel	Stainless Steel
Coating	Chrome Coat	Chrome Coat
Sizes	Same	Same
	1-2, 3-4, 5-6, 7-8	1-2, 3-4, 5-6, 7-8
Sterilization	Non-sterile	Non-sterile

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Image /page/6/Picture/1 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". The words "We are" are in gray, while "smith&nephew" is in orange.

Performance Testing

To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing were conducted on the Journey II XR Keel Punch. A review of the mechanical data and the technical memo, indicates that the Journey II XR Keel Punch are substantially equivalent to predicate devices listed in the Table above.

The following tests were used as a basis for the determination of substantial equivalence.

Finite Element Analysis .
. Stress Distribution Test

A review of the above testing demonstrated that there are no new issues related to the safety and effectiveness of the subject device and will perform as intended.

Conclusion

As previously noted, this 510(k) Premarket Notification is being submitted for a design modification to the Journey II XR Tibial Posterior Keel Punch. Based on the similarities to the predicate devices and a review of the mechanical testing performed, the subject device is substantially equivalent to the commercially available predicate devices listed above.

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.