1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
Correction of functional deformity; 2.
ల్లా Revision procedures where other treatments or devices have failed; and
1. Treatment of fractures that are unmanageable using other techniques.

The Journey Unicondylar Knee System components are single use only and are intended for implantation only with bone cement.

Device Description

The devices, subject of this Premarket Notification, are the Smith & Nephew, Inc. Journey Unicondylar Femoral Implant components. The Journey unicondylar femoral implants are intended for cemented medial and lateral tibiofemoral replacement. The femoral implants will be offered in both Cobalt Chrome and Oxidized Zirconium alloy (OXINIUM) materials in sizes 1 through 7. The Smith & Nephew Journey Unicondylar femoral components feature the same articular surface geometry as existing femoral implants cleared in K073175.

The Journey Unicondylar femoral components are intended to be used in combination with the Competitor Unicondvlar All-Poly Tibial Baseplates IK061779), or the Competitor Unicondylar Knee Tibial Baseplates and Polyethylene Inserts {K061011}.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Smith & Nephew Journey Unicondylar Femoral Implant.

Based on the provided 510(k) summary, this document is a premarket notification for a medical device (a unicondylar femoral implant), which primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not describe a study to prove the device meets specific performance acceptance criteria in the way a clinical trial or a diagnostic algorithm study would.

Therefore, I cannot populate most of the requested fields as they pertain to a type of study that isn't presented in this 510(k) document. Medical device 510(k) submissions, especially for orthopedic implants, often rely on design control activities and comparisons to predicate devices rather than human-in-the-loop diagnostic studies.

Here's what can be extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, etc.) in the context of a diagnostic or comparative effectiveness study. Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device.

Category	Acceptance Criteria (Implied for 510(k))	Reported Device Performance (as demonstrated)
Intended Use	Same as/similar to predicate device(s)	The Journey Unicondylar Knee System is indicated for restoring either compartment of a knee that has been affected by: - Noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis)- Correction of functional deformity- Revision procedures where other treatments or devices have failed- Treatment of fractures that are unmanageable using other techniques. These indications align with common uses for unicondylar knee prostheses.
Material Composition	Same as/similar to predicate device(s)	Offered in Cobalt Chrome and Oxidized Zirconium alloy (OXINIUM). (These are common materials for implants).
Design Features	Same as/similar to predicate device(s)	The femoral implants feature the same articular surface geometry as existing femoral implants cleared in K073175 (a predicate device).
Safety and Effectiveness	Demonstrated through design control activities and equivalence to predicate.	"Design Control Activities have been completed and the results indicated that the subject device is safe and effective." (No specific performance data is provided).

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance or comparative effectiveness with a "test set" of data in the manner implied by the question. The "test" for this submission is the comparison to predicates and internal design control verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

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 an orthopedic implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For a 510(k) submission for an implant, the "ground truth" essentially comes from:
* Clinical history and established performance of predicate devices: The implicit understanding that similar devices with similar materials and designs have a history of safe and effective use.
* Engineering and materials science principles: The "ground truth" for the device's physical properties (strength, wear resistance, biocompatibility) are established through standard engineering tests and material specifications. The submission only states "Design Control Activities have been completed."

8. The sample size for the training set: Not applicable. This is not an AI/machine learning study requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" presented in the 510(k):

The "study" in this context is a substantial equivalence demonstration as part of the 510(k) premarket notification process for a Class II medical device.

Objective: To demonstrate that the Smith & Nephew Journey Unicondylar Femoral Implant is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective.
Methodology:
- Comparison of Intended Use: The device's indications for use are presented and implicitly compared to those of predicate devices.
- Comparison of Technological Characteristics: The device's design features (articular surface geometry), materials (Cobalt Chrome, OXINIUM), and intended combination with other components are compared to cleared predicate devices, specifically K073175 (earlier Journey Unicondylar Femoral Implants), K912735 (GENESIS Unicompartmental Knee System), K030301 (Unicondylar Femoral Component), and K033363 (Zimmer Unicompartmental Knee System).
- Reliance on Design Controls: The submission states that "Design Control Activities have been completed and the results indicated that the subject device is safe and effective." This refers to internal company processes for designing, developing, and verifying the device meets its specifications, often including mechanical testing, biocompatibility testing (if new materials are used, though here they are common), and software verification (if applicable).
Data Provenance: The "data" primarily comes from in-house design and testing records ("Design Control Activities") and regulatory records of previously cleared devices (510(k) numbers K073175, K912735, K030301, K033363). The country of origin for the data is implicitly the USA (Smith & Nephew's location), and it is retrospective in the sense of referencing previously cleared devices and established design control processes.
Conclusion: The FDA reviewed the submission and determined the device is substantially equivalent to the identified predicate devices, allowing it to be marketed.

Summary

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JUL 2 4 2008

Kori351

510(K) Summary Smith & Nephew Smith & Nephew Journey Unicondylar Femoral Implant

SUBMITTER'S NAME:	Smith & Nephew, Inc., Orthopaedic Division
SUBMITTER'S ADDRESS:	1450 East Brooks Road, Memphis, TN 38116
SUBMITTER'S TELEPHONE NUMBER:	901-399-6017
CONTACT PERSON:	Nicholas B. Tabrizi
DATE SUMMARY PREPARED:	May 2, 2008
TRADE OR PROPRIETARY DEVICE NAME:	Smith & Nephew Journey Unicondylar Femoral Implant
COMMON OR USUAL NAME:	Unicompartmental Knee Prosthesis
CLASSIFICATION NAME:	Knee joint femorotibial metal/polymer semi constrained cementedprosthesis, 21 CFR 8888.3520
DEVICE CLASS:	Class II
PANEL CODE:	Orthopaedics/87/HSX

A. INTENDED USE:

The Journey Unicondylar Knee System is indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
Correction of functional deformity; 2.
ల్లా Revision procedures where other treatments or devices have failed; and
1. Treatment of fractures that are unmanageable using other techniques.

The Journey Unicondylar Knee System components are single use only and are intended for implantation only with bone cement.

B. DEVICE DESCRIPTION:

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ﻥ SUBSTANTIAL EQUIVALENCE INFORMATION:

The Smith & Nephew Journey Unicondylar Femoral Implant is similar to the following commercially available devices regarding design features, overall indications, and materials:

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew, Inc.	Journey Unicondylar Femoral Implants	K073175	12/28/2007
Smith & Nephew, Inc.	GENESIS Unicompartmental Knee System	K912735	12/27/1991
Smith & Nephew, Inc.	Unicondylar Femoral Component	K030301	02/25/2003
Zimmer, Inc.	Unicompartmental Knee System	K033363	01/10/2004

D. SUMMARY OF TECHNOLOGICAL COMPARISON:

The intended use, design, and materials of the Journey Unicondylar Femoral Implants are substantially equivalent to the previously cleared Journey Unicondylar Femoral Implants (K073175). Design Control Activities have been completed and the results indicated that the subject device is safe and effective.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a double helix representing DNA. The caduceus is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. Orthopaedic Division % Mr. Nicholas B. Tabrizi 1450 East Brooks Road Memphis, TN 38116

JUL 2 4 2008

K081351 Trade/Device Name: Smith & Nephew Journey Unicondylar Femoral Implant Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prothesis Regulatory Class: Class II Product Code: HSX Dated: June 24, 2008 Received: July 1, 2008

Dear Mr. Tabrizi:

Re:

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 such 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); 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.

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Page 2 -- Mr. Nicholas B. Tabrizi

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Miller

Mark N. Melkerson Director Division of General, Restorative and Neurological 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 Journey Unicondylar Femoral Implant

Indications for Use:

The Journey Unicondylar Knee System is indicated for restoring either compartment of a knee that has been affected by the following:

Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1. avascular necrosis;
1. Correction of functional deformity;
1. Revision procedures where other treatments or devices have failed; and
1. Treatment of fractures that are unmanageable using other techniques.

The Journey Unicondylar Knee System components are single use only and are intended for implantation only with bone cement.

x Prescription Use (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 ____________________________________________________________________________________________________________________________________________________________________

(Division Sigr Division of General, Restorative, and Neurological Devices

510(k) Number K081351

Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.