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The OMNI TiN Coated Apex Knee™ is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented single use implantation. This prosthesis may be used for the following conditions, as appropriate:

• · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• · Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed;
  The Apex Knee™ Modular Tibial Augments with TiN coating are intended to be bolted to the TiN coated Tibia Baseplate and cemented to the prepared tibia. The Apex Knee Revision Femur System Augments are intended to be bolted to the TiN coated femoral component and cemented to the prepared femur.

The change that is the subject of this 510(k) is to add a thin coating of Titanium Nitride (TiN) to all surfaces of all CoCrMo substrate metal components (Femoral(s), Tibial Baseplate(s), and Revision Tibia Augments) as listed in the above Predicates. The purpose of the TiN coating is to substantially reduce release of CoCrMo metal ions into body fluids, bone or soft tissues.
There is no change to the fundamental scientific technology of the referenced OMNI Predicate Knee Systems (5) with the modifications in this 510(k) submission. This includes no changes to the substrate materials, design, sterilization, packaging, or method(s) of manufacture.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The text is a 510(k) premarket notification for a medical device called the "OMNI TiN Coated Apex Knee™ System."

While it discusses the device's indications for use, its description, predicate devices, and non-clinical testing performed on the Titanium Nitride (TiN) coating, it explicitly states:

"7. Clinical Testing: No clinical studies were performed."

This immediately indicates that there will be no information regarding:

• A table of acceptance criteria and reported device performance (as this would typically come from clinical or comprehensive performance studies).
• Sample sizes for test sets, data provenance, or details about training sets (as these are relevant to studies, especially those involving AI/ML or extensive clinical trials).
• Numbers of experts, their qualifications, or adjudication methods for ground truth (again, these are related to studies, particularly those involving human interpretation or AI model validation).
• MRMC studies, effect sizes for human readers, or standalone AI performance.
• Types of ground truth established.

The document focuses on demonstrating substantial equivalence to predicate devices through

• Indications for Use,
• Material changes (addition of TiN coating), and
• Non-clinical testing of the coating properties (Chemical Composition, Thickness, Hardness, Adhesion Strength, Surface Roughness, and Wear Resistance).

Therefore, I cannot fulfill your request based on the provided text, as the necessary information for describing acceptance criteria and a study proving device performance is not present.

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The VEGA Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain. deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee ioint.

The VEGA Knee System is designed for use with bone cement.

The VEGA Knee System is a semi-constrained cemented prosthesis with a Posterior Stabilization (PS) design. The femoral component, tibial plateau and extension stem are manufactured from Cobalt Chromium Molybdenum alloy (CoCrMo) with a Zirconium nitride (ZrN) coating. The tibial "gliding surfaces" (inserts) and patella are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and the tibial plug is made of PEEK. The system is made up of numerous components available in various sizes. The VEGA Knee System is compatible with Aesculap Columbus cruciate retaining/posterior stabilizing tibial plateau and augments (CRA/PSA). All components are sterile and for single use only.

Here's an analysis of the provided FDA 510(k) summary for the VEGA Knee System, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for VEGA Knee System (K140452)

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission (K140452) is for a line extension, specifically the addition of optional compatible Aesculap Columbus CRA/PSA tibial plateau and augments to the existing VEGA Knee System.

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or in-vitro study with a specific number of units. The assessment was a geometrical worse-case comparison, which would involve analyzing the designs and dimensions of the components rather than testing a "sample size" of physical devices.
• Data Provenance: The data is based on the design specifications and geometrical properties of the existing VEGA Knee System (cleared under K101281 and K121879) and the Columbus CRA/PSA components (previously cleared in 510(K) K053390, K071220 and K120955). This is considered retrospective in the sense that it relies on previously designed and cleared components rather than newly generated test data from a prospective study. The country of origin is not explicitly stated for the designs, but the company is US-based.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. Given the nature of the "geometrical worse-case comparison," these would likely be engineering experts with expertise in orthopedic implant design, tolerancing, and biomechanics.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "study" was a geometrical comparison, not a clinical trial requiring adjudication of patient outcomes or expert consensus on clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, which is not applicable to an orthopedic implant line extension.

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

• Standalone Performance Study: No, a standalone algorithm performance study was not done. This type of study is relevant for AI/ML algorithms, which is not applicable to this physical implant device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this submission is based on engineering design principles, dimensional compatibility, and risk analysis methodologies. The "truth" is whether the combined components fit together without creating new risks or compromising the function of the knee system. This is an engineering/design-based ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This submission does not involve an AI/ML algorithm that requires a training set. The "fundamental scientific technology and materials" for the VEGA system are established.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device. The underlying design principles and performance of the predicate devices (VEGA and Columbus components) were established through their respective 510(k) clearances, which would have involved various mechanical testing, biocompatibility, and design verification activities.

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