Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
Inflammatory degenerative joint disease, including rheumatoid arthritis;
Correction of functional deformity
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.

Device Description

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.

AI/ML Overview

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:

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:

Feature/Test	Acceptance Criteria (Implied)	Reported Performance/Finding
Intended Use/Indications for Use	Identical to predicate devices.	"The indications for use are identical to the predicate devices." (Page 5) The specific indications are listed on page 2 and 4.
Device Design Features & Materials	Similar to predicate, differences not raising new safety/effectiveness concerns.	"The design features and materials of the subject devices are substantially equivalent to those of the predicate devices." (Page 4). The new device is a line extension, "porous coated for cementless fixation" (Page 4), and uses Cobalt Chrome Alloy.
Nonclinical Testing (e.g., strength)	Performs as well as or better than predicate.	"The subject EVOLUTION® MP CS/CR Porous Femur was evaluated for comparison to the predicate femur cleared in K093552, and was found not to create a worst-case with respect to intrinsic femoral component strength. The testing concluded that the subject femoral component performs as well or better than the predicate device..." (Page 5)
Fundamental Scientific Technology	Unchanged relative to predicate devices.	"The fundamental scientific technology of the modified devices has not changed relative to the predicate devices, as well." (Page 4)
Safety and Effectiveness Conclusion	Adequately supported by evidence.	"The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." (Page 4) and "The safety and effectiveness of the subject devices is adequately supported by the substantial equivalence information, materials information, and analysis data..." (Page 5)

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.
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.
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.
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.
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.
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."
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.
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).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2014

Microport Orthopedics, Incorporated Ms. Caroline Fryar Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K140735

Trade/Device Name: EVOLUTION® MP CS/CR Porous Femur Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: August 5, 2014 Received: August 6, 2014

Dear Ms. Fryar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K140735

Device Name EVOLUTION® MP CS/CR Porous Femur

Indications for Use (Describe)

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

Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis

1. Inflammatory degenerative joint disease, including rheumatoid arthritis;
1. Correction of functional deformity

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.

Type of Use (Select one or both, as applicable)

Z Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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EVOLUTION® MP CS/CR Porous Femur Traditional 510(k) Tab 005: 510(k) Summary of Safety and Effectiveness

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510(k) Summary of Safety and Effectiveness

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLUTION® MP CS/CR Porous Femur and EVOLUTION® Adaptive CS Inserts.

Submitted by:	MicroPort Orthopedics Inc.
	5677 Airline Rd, Arlington TN, 38002
	Phone: 866-872-0211
	Fax: 855-446-2247
Date:	August 27, 2014
Contact Person:	Caroline Fryar
	Regulatory Affairs Specialist
Proprietary Name:	EVOLUTION® MP CS/CR Porous Femur
	EVOLUTION® Adaptive CS and PS Inserts
Common Name:	Cementless Femoral Component
	Tibial Insert
Classification Name and Reference:	21 CFR888.3565 Knee joint Patellofemorotibial metal/Polymer
	Porous-Coated Uncemented prosthesis
	21 CFR 888.3560 Knee joint patellofemorotibial
	polymer/metal/polymer semi-constrained cemented prosthesis
	Class II

Subject Product Code and Panel Code:	Orthopedics/87/MBH
	Orthopedics/87/MBH, JWH
Predicate Devices:	EVOLUTION® MP CS/CR Non-Porous Femur (K093552, K102380)
	ADVANCE® Porous Femur (K061223)
	EVOLUTION® Adaptive CS Insert (K113325)
	EVOLUTION® Adaptive PS Insert (K131679)
	ADVANCE® Spiked Porous Tibial Base (K063128)

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DEVICE INFORMATION

A. Intended Use

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

Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic 1. arthritis, or avascular necrosis
1. Inflammatory degenerative joint disease, including rheumatoid arthritis;
Correction of functional deformity 3.
1. 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.

B. Device Description

. 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

C. Substantial Equivalence Information

The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The indications for use are identical to the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices, as well. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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D. Nonclinical Testing

The subject EVOLUTION® MP CS/CR Porous Femur was evaluated for comparison to the predicate femur cleared in K093552, and was found not to create a worst-case with respect to intrinsic femoral component strength. The testing concluded that the subject femoral component performs as well or better than the predicate device, and can be expected to perform well under normal physiological loading conditions.

E. Clinical Testing

Clinical data was not provided for the subject devices.

F. Conclusion

The design features of the subject devices are substantially equivalent to the predicate devices. The instruments and materials remain identical to those cleared under K093552, K102380, K113325, and K131679. The safety and effectiveness of the subject devices is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.