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Joint replacement is indicated for patients suffering from disability due to:

· degenerative, post-traumatic or rheumatoid arthritis;

· avascular necrosis of the femoral condyle;

· post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;

· moderate valgus, varus or flexion deformities;

· treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the FOUNDATION® Porous Coated Femur, FOUNDATION® Porous Coated Tibia Stemmed, FK/3DKNEE™ Porous Coated Downsize Tibia, 3DKNEE™ Porous Coated Femur, 3DKNEE™ Porous Coated Tibia, EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia and Patella - Metal Backed which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The Porous Patella e+TM is a sterile, single-use, non-modular metal-backed patella that is manufactured from moderately crosslinked UHMWPE blended with Vitamin E and titanium alloy. The device is offered in a symmetric, domed, design available in multiple sizes. The device is intended for cemented or uncemented applications.

Non-sterile surgical instruments are supplied with the implant.

The provided text describes a 510(k) premarket notification for the "Porous Patella e+™" device. This is a medical device submission, and the content focuses on regulatory approval rather than the results of a study demonstrating the device meets a specific set of acceptance criteria in a clinical setting.

Therefore, the input document does not contain the acceptance criteria or a study proving the device meets said criteria in the context of clinical performance or diagnostic accuracy.

The "Non-clinical Testing" section lists various types of engineering and material tests performed to demonstrate the device's substantial equivalence to a predicate device, which is a different type of evaluation from a clinical study for acceptance criteria.

Here's the breakdown of why the requested information cannot be fully provided based on the given text:

• Acceptance Criteria and Reported Device Performance: This document describes the device (Porous Patella e+™) and its indications for use, and then lists engineering tests performed to show substantial equivalence to a predicate device. It does not provide specific acceptance criteria related to a clinical outcome or diagnostic performance, nor does it report device performance against such criteria. The tests mentioned (e.g., Chemical Composition, Stereological Evaluation, Mechanical Properties, Abrasion, Initial Implant Stability, Durability) are laboratory-based engineering evaluations.
• Sample size for the test set and data provenance: Not applicable. No clinical test set is described.
• Number of experts used to establish ground truth & qualifications: Not applicable. No ground truth for a test set is discussed.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "Clinical testing was not required" and "No animal data submitted." Therefore, no MRMC study was performed or is reported.
• Standalone performance: Not applicable. This refers to algorithm-only performance, and the device is a physical medical implant, not an algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable, as there's no machine learning algorithm described.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) document is a regulatory submission focused on demonstrating substantial equivalence through non-clinical (engineering and materials) testing for a physical implant, not a clinical study to establish performance against acceptance criteria typically associated with diagnostic or therapeutic effectiveness in a human population.

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Total knee components are indicated for:

1. Rheumatoid arthritis.

2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

3. Failed osteotomies, unicompartmental replacement, or total knee replacement.

4. The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.

The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.

The subject Porous Patella is designed to be implanted with or without the use of bone cement for a total knee replacement. The Porous Patella will be made of UHMWPE and Ti-6Al-4V. The metal bone contacting surface and 3 pegs will be made from Ti-6Al-4V, which will be porous, and the bearing surface will be UHMWPE. The bone contacting porous structure will be made of CONCELOC, a material formerly cleared as part of the REDAPT CONCELOC Fully Porous Cup, K1813266. The UHMWPE will be direct compression molded on to the Ti-6AI-4V metal back. The subject Porous Patella will be designed as oval and round resurfacing patellae. The subject device will be press fit into the bone with 3 pegs for initial fixation and provided in various sizes, 26mm-41mm. As a reference, the bearing surface profile of this subject Porous Patella is identical to the Smith & Nephew Genesis II Patella, which was cleared under K042515.

The subject Porous Tibia Baseplate is designed to be implanted with or without the use of bone cement. The Porous Tibia Baseplate is made of Ti-6AI-4V and includes a porous ingrowth surface on the distal face of the implant. The proximal face of the implant includes locking mechanism, dimensions, and size options identical to Smith & Nephew's Journey cemented tibial implant cleared under K121443. The distal side of the implant has a central stem, two large posterior-directed fins, and two smaller anterior-directed fins. There are also two tibial lugs on the anterior half of the implant, one on each of the medial and lateral side of the stem. The subject device includes the same stem length for all sizes, though the fin sizes and locations of the lugs vary between sizes. The subject tibia baseplate includes multiple sizes in both left and right hand versions.

The provided document is a 510(k) premarket notification for a medical device (Porous Patella and Porous Tibia Baseplate). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials or developing complex AI algorithms. Therefore, much of the information requested about AI performance, human reader studies, and ground truth establishment in typical AI/ML medical device submissions is not applicable to this document.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance:

The document describes performance testing used to establish substantial equivalence. The acceptance criteria are implicit in meeting the performance characteristics of the predicate devices.

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

• Sample size: The document does not specify a "test set" in the context of clinical data or AI model evaluation. The tests performed are benchtop mechanical and material characterization tests. The specific number of samples for each test (e.g., number of patellae for tensile strength, number of tibia baseplates for fatigue testing) is not provided in this summary.
• Data provenance: Not applicable in the sense of patient data. The provenance for the benchtop tests would be internal laboratory testing by Smith & Nephew.

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

• This is not applicable. The device is a mechanical implant, and its performance is evaluated through engineering and material science benchtop tests, not clinical expert review or AI ground truth establishment.

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

• This is not applicable. Adjudication methods are relevant for clinical trials or expert review of diagnostic results. This submission relies on benchtop engineering tests.

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 is not applicable. This is a submission for a mechanical implant, not an AI-powered diagnostic device.

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

• This is not applicable. The device is a mechanical implant, not an algorithm.

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

• The "ground truth" for this device's performance is established by engineering and material science standards and benchmarks, generally derived from similar predicate devices and relevant industry standards (e.g., for mechanical properties, material composition, and manufacturing processes).

8. The sample size for the training set:

• This is not applicable. There is no "training set" as this is not an AI/ML device.

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

• This is not applicable. There is no "training set" or "ground truth" in the context of AI/ML for this device.

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