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Rheumatoid arthritis.
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
Failed osteotomies, unicompartmental replacement, or total knee replacement.
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.
The Genesis II Total Knee System includes porous and porous plus HA coated devices which are indicated for use with or without bone cement, and are single use devices.

Device Description

Genesis II Porous Plus HA Knee System Components contain an HA coating on the porous coated areas of the devices. These porous plus HA components are designed for use with existing knee components contained within the Genesis II Total Knee System.

AI/ML Overview

The provided text is a 510(k) summary for the Smith & Nephew Genesis II Knee System, specifically the Porous Plus HA Knee System Components. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance levels in the way a clinical trial for a new drug or an AI-powered diagnostic device might.

Therefore, many of the details requested in your prompt (e.g., sample sizes for test sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, training set details) are not applicable to this type of regulatory submission for a medical device that demonstrates substantial equivalence based on material and design similarity, and existing predicate devices.

Here's a breakdown based on the information available in the provided text:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Intended Use: The device is intended for specific knee conditions including Rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, unicompartmental replacement, or total knee replacement. The posterior stabilized system is for primary and revision surgery when cruciate ligaments are incompetent but collateral ligaments are intact.	The Genesis II Porous Plus HA Knee System Components are affirmed to be for "use with existing knee components contained within the Genesis II Total Knee System" and have the same Indications For Use as the predicate devices.
Substantial Equivalence: The device should be substantially equivalent to legally marketed predicate devices.	The Genesis II Porous Plus HA Knee System Components are deemed "substantially equivalent" to the Smith & Nephew Genesis II Knee System for Uncemented Applications (K030612), Smith & Nephew Synergy HA on Porous Hip Stems (K002996), and Smith & Nephew Echelon Porous Plus HA Hip Stems (K023302).
Design and Materials: The device's design and materials should be comparable to the predicate devices.	The document states, "The intended use, designs, and materials of the Genesis II Total Knee System are substantially equivalent to the predicate components found in the original Genesis II System submissions previously cleared by FDA."
Applicable FDA Guidance Compliance: The device should meet the requirements of applicable FDA guidance documents.	"Summary report results indicate that the subject devices meet the requirements of the applicable FDA guidance documents." (Specific guidance documents and the "summary report" details are not provided in this excerpt).

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

Not Applicable. This submission is for establishing substantial equivalence based on material and design comparisons to predicate devices, not a clinical study with a test set of patient data. The "test set" in this context would refer to material and mechanical testing data, which is not detailed in the provided 510(k) summary.

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

Not Applicable. This type of information is generally relevant for AI/ML device submissions where expert annotation is used to create a ground truth for diagnostic accuracy. Given this is a knee implant, the "ground truth" would relate to material properties, mechanical performance, and biocompatibility, typically evaluated through engineering tests, not expert clinical interpretation of data.

4. Adjudication method for the test set:

Not Applicable. As per the above, there isn't a traditional "test set" requiring clinical adjudication.

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. MRMC studies are specific to diagnostic devices, especially those involving human interpretation of medical images, and are not relevant for a knee implant 510(k) submission.

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

Not Applicable. This is a hardware device (a knee implant), not an algorithm or software device.

7. The type of ground truth used:

For this type of device, the "ground truth" for demonstrating substantial equivalence would primarily be objective engineering performance data (e.g., mechanical strength, wear characteristics, biocompatibility of materials, fixation properties) as tested against recognized standards and compared to the predicate devices, along with clinical history and performance of the predicate devices. The provided text mentions "summary report results" indicating compliance with FDA guidance, which would encompass such engineering data.

8. The sample size for the training set:

Not Applicable. This is not a machine learning or AI device that uses a "training set."

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

Not Applicable. No training set exists for this type of device.

In summary: The K032683 submission for the Genesis II Porous Plus HA Knee System components relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This is achieved by showing that the new device has the same intended use, similar technological characteristics (design, materials, HA coating on porous areas), and meets applicable FDA guidance documents, implying that relevant engineering and biocompatibility tests were performed and their results deemed acceptable by the FDA in relation to the predicate devices. The document does not describe a clinical study in the typical sense with patient sample sizes, expert-adjudicated ground truth, or AI performance metrics.

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