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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; 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 absent or incompetent and the collateral ligaments remain intact. The Smith & Nephew Legion Porous Plus HA Primary Femoral Components are indicated for use without bone cement and are single use devices.

Legion Porous Plus HA Primary Femoral Components are geometrically identical to the Legion Porous Primary femoral components cleared via K073325. This premarket notification seeks only to add a hydroxylapatite (HA) coating to the porous coated areas of the femoral implants. The subject devices will be initially offered in both cruciate retaining (CR) and posterior stabilizing (PS) designs in sizes 1-8 in right and left hand configurations. The subject devices will utilize the same articular inserts as the non-HA coated Legion Porous Primary femoral components cleared via K073325 and will use existing Genesis II tibial baseplate and patellar components cleared via K030612.

This 510(k) premarket notification for the LEGION Porous Plus HA Primary Femoral Components does not present a study proving the device meets specific acceptance criteria in the way a clinical study for diagnostic accuracy would.

Instead, this submission establishes substantial equivalence to previously cleared predicate devices through a comparison of design, indications, and mechanical testing. The acceptance criteria here are related to demonstrating this equivalence, rather than a quantifiable performance metric for a new claim.

Here's a breakdown of the requested information based on the provided document, noting where information is not applicable due to the nature of this 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

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 in the context of a clinical test set. The provided document describes mechanical testing and a comparison to predicate devices, not a clinical study with a test set of patient data. The "test set" here would refer to the samples of the device undergoing mechanical evaluation. The document does not specify the number of samples used for mechanical testing. Data provenance is not specified.

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. This submission relies on engineering and regulatory review (mechanical testing, equivalence to predicate device specifications), not expert clinical adjudication of a test set for diagnostic performance.

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

• Not applicable. See point 3.

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. This is not a diagnostic AI device.

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

• No. This is not an algorithm or AI device.

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

• The "ground truth" in this context is established by:
  • Mechanical Engineering Standards: The ability of the device to withstand expected in vivo loading, demonstrated through standard mechanical tests.
  • Predicate Device Specifications: The established design, indications, materials, and HA coating of previously cleared devices (K073325 and K032683).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. See point 8.

Summary of the Study/Evidence:

The "study" in this 510(k) is primarily a comparison of the new device (Legion Porous Plus HA Primary Femoral Components) to legally marketed predicate devices and verification through mechanical testing. The core argument is manufactured equivalence and performance consistency with devices already on the market.

The key "evidence" presented is:

• Geometric identity to the Legion Porous Primary femoral components (K073325).
• Use of the same HA coating as devices in the Genesis II Porous Plus HA Knee System (K032683).
• Mechanical testing results showing the device is capable of withstanding expected in vivo loading without failure, indicating equivalence to clinically used devices.
• Similar overall design, indications, and materials to the predicate device.

This approach is typical for 510(k) submissions where a new device is very similar to an already cleared one, with minor modifications (in this case, the addition of an HA coating to an existing femoral component design). The "acceptance criteria" are met by demonstrating this substantial equivalence.

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