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The patient should be skeletally mature to receive a World Knee replacement system. 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 World Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.

Devices covered in this 510(K) are a range extension to previously cleared 510(K) applications for World Knee system. The range extension consists of titanium tibial baseplates for the World knee, and a change to the meniscal insert connection mechanism for the World knee. The tibial baseplate is made of Titanium available in cemented version. The World Knee meniscal inserts are available as posterior stabilized or cruciate retaining variants. Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. All variants of the meniscal inserts are manufactured from UHMWPE.

This document is a 510(k) premarket notification for the "World Knee Total Knee System." It's a submission to the FDA for a medical device and describes its indications for use and performance testing related to its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for a software or AI-driven medical device, nor does it report performance in terms of metrics like sensitivity, specificity, or accuracy which are common for AI/software devices. This submission is for a physical orthopedic implant.

Instead, the "Performance Testing" section describes a series of non-clinical mechanical tests performed on the World Knee System to ensure its physical integrity and safety. The acceptance criteria for these tests would be defined by the referenced ASTM standards. The reported performance is that these tests were "conducted to verify that the performance of the World Knee system is adequate for anticipated in-vivo use" and that "Non-clinical testing results support the substantial equivalence claim."

Here's a re-interpretation of "acceptance criteria" for this physical device:

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

This document describes testing for a physical orthopedic implant, not a software (AI) device. Therefore, the concepts of "test set" sample size and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the way they would be for an AI device.

The "sample size" for the performance tests would refer to the number of physical components or assemblies tested according to the referenced ASTM standards. This information is not provided in the document.

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

This is not applicable as the device is a physical implant, not an AI device requiring expert-established ground truth for a test set. The "ground truth" for a physical device is established through engineering and material science principles, and adherence to validated testing standards (like ASTM).

4. Adjudication Method for the Test Set

This is not applicable for a physical implant. Performance is evaluated against objective engineering standards.

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. The device is a physical knee implant, not an AI system that assists human readers.

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

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

7. The Type of Ground Truth Used

For this medical device (a knee implant), the "ground truth" for evaluation is based on established engineering and material science standards, biomechanical principles, and compliance with recognized standards organizations like ASTM. The safety and effectiveness are "ground-truthed" by demonstrating that the device meets the physical and biological requirements for its intended use, often through:

• Mechanical Testing Results: Demonstrating strength, fatigue resistance, and durability under simulated physiological loads.
• Material Characterization: Verifying that materials meet specifications and are biocompatible.
• Clinical Literature/Predicate Device Equivalence: Relying on the known performance and safety profile of similar predicate devices that have been used safely in patients for years.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical orthopedic implant, not an AI system that undergoes training.

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

This is not applicable.

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