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· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configurations and function.
· Moderate Varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.

• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture-management techniques.
• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• · Absent or non-functioning posterior cruciate ligament.
• · Severe anteroposterior instability of the knee joint
  · Optimotion™ Blue Plus Knee System and Optimotion™ Blue Total Knee System non-porous implant components are indicated for cemented use only.
  · Optimotion™ Blue Plus Knee System and Optimotion™ Blue Total Knee System porous coated implant components are indicated for cemented or uncemented use.

The Optimotion™ Blue Plus Knee System is a line addition to the Optimotion™ Blue Total Knee System (K191084) consisting of a posterior stabilizing (PS) femoral and PS tibial insert components. The femoral component is composed of CoCrMo alloy, non-porous for cemented use. The femoral component is to be used with PMMA bone cement. The tibial insert components are composed of UHMWPE with Vitamin E. The Optimotion™ Blue Plus Knee System is intended for cemented replacement of the femur and articulating surfaces of the knee.

Femoral Component: The femoral component is symmetric. The femoral component is available in posterior stabilizing (PS) design and is offered in eight (8) sizes. The system is designed to allow each size femoral component to be interchangeable with the next size up, the same size, or the next size down Optimotion™ Blue Tibial Tray and corresponding Optimotion™ Blue Plus PS Tibial Insert.

Tibial Inserts: The PS Tibial Insert components are symmetric and available in three configurations for varying levels of constraint. The three configurations from lowest to highest constraint are Low Post (LP), Low Post Plus (LP+), and High Post (HP). The LP Tibial Insert has the shortest and smallest perimeter post and the HP Tibial Insert has the highest and largest perimeter post, with the LP+ containing a post that is between the LP and HP post sizes. Each configuration of PS Tibial Insert is offered in eight (8) sizes and seven (7) thicknesses. The tibial insert components are compatible with the Tibial Tray Components of the Optimotion™ Blue Total Knee System.

The provided text describes a 510(k) summary for the Optimotion™ Blue Plus Knee System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with detailed acceptance criteria, performance metrics, and expert adjudication as one might find for a novel AI device.

Therefore, the requested information elements related to AI device performance evaluation (acceptance criteria table, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type for test and training sets) are not applicable to this document. The document describes a traditional medical device (knee implant) and its regulatory clearance process, not a software or AI-driven diagnostic device.

The "Performance Data" section primarily addresses biomechanical testing, material equivalence, and design comparisons, which are standard for orthopedic implants, and generally does not involve the detailed clinical study methodologies requested.

Here's a summary of what is available in the document:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. This document does not describe specific numerical acceptance criteria for a diagnostic or AI performance study. Instead, it refers to fulfilling "standards for total knee replacement devices" and being "substantially equivalent" to the predicate device.
  • For example, it mentions that "The minimum tibial insert thickness was tested using Solidworks CAD drawing analysis to confirm that the minimum thickness of the thinnest, smallest size PS Tibial Insert is greater than 6mm." This is a design specification, not an acceptance criterion for a clinical or AI performance study.
  • "Shear static and fatigue testing were performed using the thickest and largest size HP PS Tibial Insert" is also a form of mechanical testing, not a clinical performance metric.

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. This document describes mechanical and design testing, not a clinical trial with a "test set" in the context of AI or diagnostic performance. Therefore, details about data provenance (country, retrospective/prospective) are not provided.

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. No ground truth establishment by experts for a test set is described, as this is a physical implant device, not a diagnostic or AI system requiring expert interpretation of results for performance evaluation.

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

• Not Applicable. There is no test set or adjudication method described for performance evaluation in the context of AI or diagnostic devices.

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. This is a physical knee implant, not an AI-assisted diagnostic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• Not Applicable. This device is a physical implant, not an algorithm.

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

• Not Applicable. As no diagnostic performance study is described, there is no mention of "ground truth" in the context of expert consensus, pathology, or outcomes data for training or testing a diagnostic algorithm. The "ground truth" for this device relates to manufacturing specifications and material properties validated through engineering tests.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is a physical implant and not an AI or machine learning model.

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

• Not Applicable. No training set is involved.

Summary of Relevant Information from the Document:

• Device: Optimotion™ Blue Plus Knee System (knee joint prosthesis)
• Basis for Clearance: Substantial Equivalence to predicate devices (K191084 and K141056).
• Performance Data Types:
  • Wear simulation analysis (referenced from previously approved components per ISO 14243-(1)-2002).
  • Solidworks CAD drawing analysis for minimum tibial insert thickness (confirmed >6mm).
  • Solidworks CAD analysis for range of motion.
  • Shear static and fatigue testing for the locking mechanism of PS Tibial Inserts (due to addition of a post).
  • Validation studies for packaging, shelf life, and Bacterial Endotoxin Tests (referenced from previously cleared devices, ANSI/AAMI standards).
• Conclusion: The device meets standards and is substantially equivalent based on indications for use, materials, design, size, and performance data.

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