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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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Joint replacement is indicated for patients suffering from disability due to:

· degenerative, post-traumatic or rheumatoid arthritis;

· avascular necrosis of the femoral condyle;

· post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;

· moderate valgus, varus or flexion deformities;

· treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur which is intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The Empowr CR Knee™ Tibial Insert is a line extension to the EMPOWR platform, to include Cruciate Retaining Knee implants and instruments, which provides surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences. The Empowr CR Knee™ Tibial Insert utilizes a PCL (posterior cruciate ligament) retaining TKA (total knee arthroplasty) procedure.

The tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE. The tibial inserts are intended to mate with tibial base implants made from cast CoCr alloy per ASTM F75. The Empowr CR Knee™ Tibial Insert implants provide a kinematically relevant bearing geometry for the knee's primary articulating surfaces, replacing the medial and lateral tibial compartments. The articular geometry features a less conforming asymmetric condylar surfaces to match the highly polished Empowr 3D distal femoral implant's asymmetric condylar surfaces. The distal side of the implant includes a precisely machined coupling designed to interface and lock with the EMPOWR tibial base implant. The tibial insert implant also offers soft tissue relief sections in the anterior region for the patellar tendon and the posterior region for the PCL in PCL retaining procedures.

This response describes the acceptance criteria and study that proves the device meets the acceptance criteria based on the provided document.

It's important to note that the provided document is a 510(k) Premarket Notification for a medical device (Empowr CR Knee Tibial Insert), and as such, the "acceptance criteria" discussed are primarily related to demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than performance criteria for an AI/CADe device. The document explicitly states that clinical testing was not required.

Therefore, the answers below will reflect the information available for a mechanical orthopaedic implant, not AI software. Many of the requested fields pertinent to AI/CADe studies will be marked as "Not Applicable" or "Not Provided" due to the nature of the device and the submission type.

Acceptance Criteria and Device Performance for Empowr CR Knee™ Tibial Insert

The acceptance criteria for the Empowr CR Knee™ Tibial Insert are based on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing, rather than a clinical performance study typical for AI/CADe software.

1. Table of Acceptance Criteria and Reported Device Performance

Summary Conclusion: All testing and evaluations demonstrated that the device is substantially equivalent to the identified predicate devices.

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

For mechanical testing of physical implants:

• Sample Size: Not explicitly stated as a numerical value (e.g., number of inserts tested). Mechanical tests typically involve multiple samples to ensure statistical validity, but the specific quantity is not reported in this summary.
• Data Provenance: Not applicable in the context of human data. The testing is performed on physical device samples in a laboratory setting. It is not retrospective or prospective human data.

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

• Not Applicable. This is a hardware device (knee implant), not an AI/CADe system requiring expert adjudication of images or clinical outcomes for performance evaluation. Ground truth for mechanical performance is established by engineering standards and test methods.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication of results in the sense of consensus reading for AI algorithm evaluation. Mechanical testing results are objective measurements against established engineering principles and benchmarks.

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

• No. An MRMC study is relevant for medical image analysis AI/CADe systems to assess human reader performance with and without AI assistance. This device is a knee implant, and as such, this type of study was not performed or necessary for its submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

• No. This question is also focused on AI algorithm performance. For this physical device, mechanical testing evaluates the device's inherent properties and performance in a controlled lab environment, which is analogous to "standalone" performance but in a mechanical context. It's not an algorithm.

7. The Type of Ground Truth Used

• Engineering Standards and Benchmarks: The "ground truth" for this device's performance evaluation comes from established mechanical testing standards (e.g., ASTM standards, though not explicitly cited in the summary, they are typically used for such tests) and comparative data from the legally marketed predicate devices. The performance of the new device is compared against the known safe and effective performance of the predicate.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device, not an AI model requiring a training set of data.

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

• Not Applicable. As no training set was used for an AI model, this question is not relevant.

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