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The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.

The patient's need for knee replacement should be due to one or more of the following conditions:

• . Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
• . Inflammatory degenerative joint disease including rheumatoid arthritis.
• Functional deformity such as varus, valgus or flexion deformities.
• . Revision procedures where other treatments or devices have failed.
• . Fractures that are unmanageable using other techniques.

The Genius Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.

The Genius Knee system is a modular knee system consisting of a femoral component, meniscal insert, a patella and a tibial baseplate. The femoral component and tibial baseplate components are manufactured from cast cobalt chromium alloy and are intended for use with bone cement. The femoral component is available with femoral pegs, or as modular peg variant. The modular femoral peg is manufactured from wrought cobalt chromium alloy. The femoral component and meniscal inserts are available as posterior stabilised or cruciate retaining variants. Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. All variants of the meniscal insert and patella are manufactured from UHMWPE.

The provided document is a 510(k) premarket notification for a medical device called the "Genius Total Knee System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with acceptance criteria directly applicable in the way you're asking. Therefore, the information typically requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) is generally not part of a 510(k) for a knee replacement system, as it's not a diagnostic AI/ML device.

However, I can extract the relevant information regarding the performance testing and the grounds for substantial equivalence.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a knee replacement system undergoing 510(k) clearance, the "acceptance criteria" are typically defined by engineering parameters and validated through non-clinical bench testing, ensuring the device meets established mechanical and material standards for orthopedic implants. The "reported device performance" is that the device met these engineering and material specifications.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable in the context of a 510(k) for a physical knee implant based on non-clinical bench testing. There isn't a "test set" of patient data in the way you might find for an AI/ML diagnostic device. The "test set" consists of physical devices that undergo various mechanical and material tests. The provenance of the data is from in-house engineering and material testing labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. "Ground truth" in this context is defined by objective engineering and material standards (e.g., ISO, ASTM standards for orthopedic implants), not by expert medical interpretation of data. The expertise lies in the engineers and material scientists conducting and evaluating the tests.

4. Adjudication Method for the Test Set

This is not applicable. The results of the non-clinical tests are objective measurements against established technical specifications, not subjective interpretations requiring 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

This is not applicable. This device is a physical knee implant, not an AI-assisted diagnostic or treatment planning tool that would involve human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This device is a physical knee implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Genius Total Knee System is based on:

• Engineering and Material Standards: Compliance with relevant national and international standards (e.g., ASTM, ISO) for static, dynamic, and fatigue strength, material properties, and biocompatibility of orthopedic implants.
• Predicate Device Performance: The expectation that, by demonstrating similar design, materials, and mechanical performance to legally marketed predicate devices, the subject device will perform equivalently in clinical use.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" of data for this type of device submission.

9. How the Ground Truth for the Training Set Was Established

This is not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (defined as adequate mechanical and material performance for in-vivo use and substantial equivalence to predicate devices) consists of a battery of non-clinical bench tests and engineering evaluations. These tests covered aspects such as range of motion, modular component interlock strength, contact area and stress, component constraint, tibial plate fatigue, UHMWPE tibial post strength, modular component assembly and disassembly, and endotoxin (LAL) testing.

The document claims that these non-clinical testing results support the substantial equivalence claim to several predicate devices, including the DePuy PFC Sigma Knee System (K943462), Signature Orthopaedics Active-X Knee System (K160159), Biomet Vanguard Complete Knee System (K113550), DePuy AMK System (K864671), and New Era Orthopaedics NEO Total Knee System (K142388). The conclusion is that "The subject devices are expected to perform adequately during clinical use."

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