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The EVOLUTION® MP CS/CR Porous Femur is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION® MP CS/CR Porous Femur is for uncemented use only.

The EVOLUTION® MP CS/CR Porous Femur is a line extension of the EVOLUTION® MP Total Knee System product line. The device is a distal femoral knee joint replacement implant, and is porous coated for cementless fixation. The design features are summarized below:

• Manufactured from Cobalt Chrome Alloy
• Inner surfaces coated with porous beads for cementless fixation
• Available in sizes 1-8, left and right
• Compatible with 510(k) cleared EVOLUTION® Tibial Inserts and ADVANCE® Patellae

The tibial compatibility for the EVOLUTION® Adaptive CS and PS Tibial Inserts is being expanded to include all 510(k) cleared ADVANCE® II Tibial Bases. The subject designs and indications remain identical according to their respective 510(k) clearances.

This document is a 510(k) premarket notification for a medical device called the EVOLUTION® MP CS/CR Porous Femur. It is a submission to the FDA seeking clearance to market the device based on 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 with corresponding device performance metrics in the way one might see for, say, an AI diagnostic device. Instead, the "acceptance criteria" are implied by the FDA's regulatory framework for 510(k) submissions, which centers on demonstrating substantial equivalence to a predicate device.

   • Acceptance Criteria (Implied by 510(k) process):

     • Indications for Use are identical or narrower than predicate.
     • Technological characteristics are similar, or differences do not raise new questions of safety and effectiveness.
     • Performance data (nonclinical and, if necessary, clinical) demonstrates the device is as safe and effective as the predicate.

   • Reported Device Performance:

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

   • Sample Size: The document does not specify a numerical sample size for the nonclinical testing in terms of component quantity. It states the "subject EVOLUTION® MP CS/CR Porous Femur was evaluated for comparison to the predicate femur cleared in K093552". This usually implies physical testing of several samples per design, but the exact number isn't provided.
   • Data Provenance: The testing was "nonclinical testing" (Page 5), meaning it was likely laboratory-based mechanical or material property testing rather than involving human subjects or real-world patient data. The provenance is therefore controlled laboratory conditions. No country of origin for test data is mentioned, but given the submission is to the US FDA by a US-based company, the testing most likely adhered to US or internationally recognized standards.

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

   • This question is not applicable in the context of this device and submission. "Ground truth" established by experts is typically for diagnostic devices where human interpretation is involved. For a knee prosthesis like this, "ground truth" refers to the objective physical properties and performance characteristics measured in laboratory settings, compared against established engineering standards and predicate device performance.

4. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in tasks like image interpretation, which is not relevant here.

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

   • No. An MRMC study is for evaluating the performance of diagnostic systems (often AI) with and without human assistance. This device is a surgical implant; therefore, such a study would not be relevant.

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

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

7. The Type of Ground Truth Used:

   • The "ground truth" for this device, within the context of the 510(k) submission, is based on objective engineering and material performance standards, and comparison to the established performance of the predicate device. The nonclinical testing evaluated intrinsic femoral component strength and concluded it performed "as well or better than the predicate device."

8. The Sample Size for the Training Set:

   • Not applicable. This device does not involve a "training set" in the machine learning sense. The design and manufacturing process for the device would be informed by decades of biomechanical research, engineering principles, and experience with previous implant designs, but there isn't a "training set" of data in the AI/ML context.

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

   • Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for developing such a device relies on a combination of:
     • Biomechanical understanding of knee joint function and loading.
     • Materials science data on Cobalt Chrome Alloy.
     • Design principles and historical performance data from similar orthopedic implants (including predicate devices).
     • Compliance with relevant ASTM or ISO standards for orthopedic implants.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence primarily through nonclinical testing and comparison of fundamental technological characteristics and indications for use against predicate devices. It explicitly states that "Clinical data was not provided for the subject devices" (Page 5).

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