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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.

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.

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

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.

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Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

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

Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.

The Journey II Uni tibial baseplate and inserts are modifications of the existing Journey Uni tibial baseplate and inserts that were previously cleared for market via K102069 (baseplates) and K061011 (inserts). The subject of this premarket notification are modifications to the insert locking mechanism on the tibial baseplate and insert, articular surface geometry, sizing of baseplate and inserts, and characteristics of the cemented surface of the baseplate. Additional device specific instruments are also included as part of the submission.

The Journey II Uni inserts are available in left medial/right lateral and right medial/left lateral cross-linked polyethylene articular inserts and titanium alloy (Ti-6Al-4V) tibial bases which will be available in left medial/right lateral and right medial/left lateral.

The Journey II Uni tibial baseplate and inserts will use existing Journey Uni femoral components cleared via K081351 or GENESIS Uni femoral components cleared via K912735.

This document pertains to the clearance of a medical device, specifically the Journey II Uni Tibial Base and Insert, a unicompartmental knee implant. The information provided outlines the reasoning for its substantial equivalence to previously cleared devices rather than a study designed to meet specific acceptance criteria for a novel device. Therefore, many of the requested fields regarding acceptance criteria and study details are not directly applicable in the context of this 510(k) submission.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in the form of quantitative thresholds for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through mechanical testing and design similarities. The "performance" reported is that the device is equivalent to existing, legally marketed predicate devices.

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

• Sample Size: The document lists types of mechanical tests performed (Unsupported Baseplate Fatigue Testing, Static testing of the insert locking mechanism, Fully Supported Fatigue/Cement Adhesion Testing, Contact Area Analysis). However, it does not specify the sample sizes used for these tests.
• Data Provenance: The data is generated from mechanical verification testing/analysis conducted by Smith & Nephew, Inc. It is not clinical data, nor is its country of origin or retrospective/prospective nature specified, as these are mechanical tests, not human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The ground truth for mechanical testing is based on engineering principles and established testing standards, not expert consensus as in diagnostic accuracy studies.

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

This section is not applicable as there is no human interpretation or adjudication involved in the mechanical tests 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

This section is not applicable. This submission is for a knee implant, not an AI-powered diagnostic device. No MRMC study was conducted.

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

This section is not applicable. This is not an algorithm or software device.

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

The "ground truth" for the assessment of this device is its mechanical performance relative to established predicate devices, as determined by engineering tests and analyses, adhering to relevant standards for medical device design and manufacturing.

8. The sample size for the training set

This section is not applicable. This is not a machine learning or AI device that requires a training set.

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

This section is not applicable. No training set was used.

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