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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 primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact

The Smith & Nephew Cemented Tibia Baseplate no Taper with JRNY Lock are indicated for use with cement only and are single use devices.

The subject devices of this Special 510(k) are the Cemented Tibia Baseplate no Taper with JRNY Lock. The subject Cemented Tibia Baseplate no Taper with JRNY Lock are tibia baseplate components, and a line extension of the ANTHEM Tibia Baseplate cleared under premarket notification K142807 (S.E. 12/22/2014). The subject devices were modified by incorporating the identical JOURNEY II locking mechanism for the JOURNEY II BCS Knee System, cleared under premarket notifications K111711 (S.E. 09/16/2011).

The subject Cemented Tibia Baseplate no Taper with JRNY Lock is designed to be implanted with the use of bone cement and is made of Ti-6Al-4V. The proximal face of the implant includes locking mechanism, dimensions, and size options identical to Smith & Nephew's JOURNEY Nonporous Tibia Baseplate, originally cleared under premarket notification K042515 (S.E. 03/14/2005) and updated under the JOURNEY II BCS Knee System premarket notifications K111711 (S.E. 09/16/2011) respectively. The distal side of the implant has a central stem and two large posterior-directed fins. The subject device includes the same stem length for all sizes, though the fin sizes vary between baseplate sizes. The distal side of the implant has an identical design to Smith & Nephew's ANTHEM Tibia Baseplate, cleared under premarket notification K142807 (S.E. 12/22/2014). The subject Cemented Tibia Baseplate no Taper with JRNY Lock includes multiple sizes in both left and right versions.

The subject inserts of the system, compatible with the subject Cemented Tibia Baseplate no Taper with JRNY Lock, have been previously cleared via premarket notification K220896 (S.E. 04/26/2022) to include the JOURNEY II Locking Mechanism. The articulating surface of the subject inserts have remained identical to the primary predicate system, ANTHEM PS Total Knee System cleared via premarket notification K142807 (S.E. 12/22/2014). Therefore, the existing femoral components cleared for the system via premarket notification K142807 (S.E. 12/22/2014) continue to be compatible and remain unchanged.

This document is a 510(k) summary for a medical device (Cemented Tibia Baseplate no Taper with JRNY Lock), seeking substantial equivalence to predicate devices, not a study performing extensive clinical testing with detailed acceptance criteria and performance data as would be provided for a new, novel AI/ML device. Therefore, much of the requested information regarding acceptance criteria, study design (sample size, experts, ground truth, MRMC), and training sets for AI models is not applicable to this type of submission.

This submission primarily relies on mechanical performance data and comparisons to existing, cleared predicate devices. The conclusion explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."

However, I can extract the relevant information where available and explain why other sections are not applicable.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance (Not Applicable in the context of an AI/ML device)

This document is for a medical device (a knee implant component), not an AI/ML device. Therefore, the concept of "acceptance criteria" and "device performance" as it pertains to statistical measures like sensitivity, specificity, accuracy, or reader improvement, does not apply in the same way.

The "acceptance criteria" here are based on the substantial equivalence to predicate devices through design similarity, material composition, and demonstration of equivalent mechanical performance (via leveraged data).

The "reported device performance" is essentially the successful demonstration that its mechanical performance (specifically the locking mechanism) is equivalent to or better than previously cleared devices and that it meets endotoxin limits.

Table of Acceptance Criteria and Reported Device Performance (as applicable to a physical device):

Study Details (Not Applicable for most AI/ML questions)

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

• Not applicable for clinical data. The submission states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."
• For mechanical testing, the "sample size" would refer to the number of physical devices or components tested. This specific number is not provided, but the statement "A review of the leveraged mechanical data" implies that existing or previously generated test data from the predicate devices (K111711) was utilized. The provenance would be from laboratory mechanical testing of these devices.

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

• Not applicable. This submission does not involve human expert interpretation of data to establish ground truth in the way an AI/ML device would (e.g., radiologists reviewing images). The ground truth for mechanical testing is established by engineering standards and measurements.

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

• Not applicable. No human adjudication process as implied by this question. Mechanical testing results are objectively measured.

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 is a physical medical device, 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 is a physical medical device.

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

• Mechanical ground truth: Established through engineering specifications, validated test methods (e.g., force, displacement measurements), and compliance with relevant standards (e.g., ISO, ASTM for medical device mechanical testing).
• Biocompatibility ground truth: Established through laboratory testing for endotoxin levels compared to pre-defined acceptable limits in regulatory guidance (FDA Guidance, ANSI/AAMI ST72).

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this physical medical device submission.

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

• Not applicable.

In summary: This 510(k) submission for a knee implant component primarily leverages existing data from predicate devices and mechanical testing to demonstrate substantial equivalence, rather than conducting a clinical study with human readers/interpreters or training an AI/ML model. Therefore, many of the questions asked, which are highly pertinent to AI/ML device submissions, are not applicable here.

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