The ADVANCE® BIOFOAM® and EVOLUTION® BIOFOAM® tibial bases are indicated for use in knee athroplasty in skeletally mature patients with the following conditions:

Non-inflammatory degenerative joint disease: including osteoarthritis, 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 ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants are for cementless use only.

The DYNASTY® BIOFOAM® Acetabular Shell is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli, and painful hip dysplasia;
Inflammatory degenerative joint disease such as rheumatoid arthritis;
Correction of functional deformity;
Revision procedures where other treatments or devices have failed.
The DYNASTY® BIOFOAM® Acetabular Shell is for uncemented use only.

Device Description

A process change is taking place to introduce BIOFOAM® Additive Manufacturing (BIOFOAM® AM) as an alternative to the currently manufactured BIOFOAM® material used as a porous coating. BIOFOAM® AM will be used as a porous coating for MicroPort Orthopedics' tibial bases and acetabular shells with the current BIOFOAM® material as a porous coating. The BIOFOAM® AM is a porous material manufactured from the same raw material as the predicate, Commercially Pure Titanium conforming to ASTM F67, The surface treatment of BIOFOAM® AM is identical to the predicate and helps to provide initial fixation. The structure and porosity of BIOFOAM® AM is designed to encourage bone apposition.

AI/ML Overview

The provided documentation is a 510(k) Summary for a medical device and does not contain the detailed data or study design typically found in a clinical study report or a validation study for an AI/ML powered device. This document describes the "BIOFOAM® Additive Manufacturing (BIOFOAM® AM)" as an alternative porous coating material for existing orthopedic implants, not an AI/ML device.

Therefore, many of the requested sections about AI/ML device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and standalone performance metrics are not applicable to the information provided in this document. The document focuses on demonstrating substantial equivalence of a new manufacturing process for a material to existing predicate devices, primarily through non-clinical testing.

However, I can extract the relevant information regarding the acceptance criteria (or performance metrics) used for the material and the study that proves it meets those criteria based on the provided text:

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

Performance Metric	Acceptance Criteria (Implied by FDA Guidance/Predicate Equivalence)	Reported Device Performance (BIOFOAM® AM)
Static Shear Strength	Greater than required by FDA Guidance Document and substantially equivalent to predicate.	Achieved static shear strength greater than required by FDA Guidance and substantially equivalent to predicate.
Static Tensile Strength	Greater than required by FDA Guidance Document and substantially equivalent to predicate.	Achieved static tensile strength greater than required by FDA Guidance and substantially equivalent to predicate.
Shear Fatigue Strength	Substantially equivalent to predicate.	Substantially equivalent to predicate.
Abrasion Resistance	Performs as well as predicate.	Performs as well as predicate, expected to resist abrasive in vivo forces.
Material Purity	Commercially Pure Titanium conforming to ASTM F67.	Manufactured from Commercially Pure Titanium conforming to ASTM F67.
Stereological Evaluation	(Not explicitly stated, but implies meeting established material characteristics).	Completed per ASTM F1854. (Specific results not detailed, but implied to be acceptable for substantial equivalence).
Build Parameters Validation	(Successful validation)	Performed and validated.
Print Chamber Validation	(Successful validation - orientation, location)	Performed and validated.
Powder Recycle Validation	(Successful validation)	Performed and validated.
Residual Powder Removal	(Successful demonstration)	Performed and demonstrated.
Bacterial Endotoxin Testing	(Acceptable levels)	Performed. (Implied to be acceptable, as substantial equivalence was granted).

2. Sample sizes used for the test set and the data provenance:

Sample Size: Not specified in the provided summary.
Data Provenance: Not applicable as this is a non-clinical material testing study, not a study involving human data.

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. Ground truth for material performance is established through recognized ASTM standards and engineering measurements, not expert consensus in a medical diagnostic context.

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

Not applicable. This is a non-clinical material testing study.

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 non-clinical material testing study, not an AI/ML device.

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

Not applicable. This is a non-clinical material testing study, not an AI/ML device.

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

The "ground truth" for this device's performance is based on established engineering and material science standards (e.g., ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1854) and comparisons to the performance of the predicate device materials. FDA Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces also served as a benchmark.

8. The sample size for the training set:

Not applicable. This is a new material/manufacturing process, not an AI/ML model that requires training data.

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

Not applicable.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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

June 15, 2017

Microport Orthopedics, Inc. Ms. Grace Johnson-Bann Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K170288

Trade/Device Name: BIOFOAM® Additive Manufacturing (BIOFOAM® AM), EVOLUTION® BIOFOAM® Tibial Base, ADVANCE® BIOFOAM® Tibial Base. DYNASTY® BIOFOAM® Acetabular Shell Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, LZO Dated: May 4, 2017 Received: May 5, 2017

Dear Ms. Johnson-Bann:

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.

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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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Vincent J. Devlin -S

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)

K170288

Device Name

BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell

Indications for Use (Describe)

The ADVANCE® BIOFOAM® and EVOLUTION® BIOFOAM® tibial bases are indicated for use in knee athroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, 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 ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants are for cementless use only.

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli, and painful hip dysplasia;
Inflammatory degenerative joint disease such as rheumatoid arthritis;
Correction of functional deformity;
Revision procedures where other treatments or devices have failed.

The DYNASTY® BIOFOAM® Acetabular Shell is for uncemented use only.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle containing a red star-like shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" underneath in red.

BIOFOAM® Additive Manufacturing Traditional 510(k) 510(k) Summary

510(k) Summary

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® Revision Tibial System.

Submitted by:	MicroPort Orthopedics Inc.
	5677 Airline Rd, Arlington TN, 38002
	Phone: 866-872-0211
	Fax: 855-446-2247
Date:	June 15, 2017
Contact Person:	Grace Johnson-Bann
	Regulatory Affairs Specialist II
Proprietary Name:	BIOFOAM® Additive Manufacturing (BIOFOAM® AM)
	EVOLUTION® BIOFOAM® Tibial Base
	ADVANCE® BIOFOAM® Tibial Base
	DYNASTY® BIOFOAM® Acetabular Shell
Common Name:	Cementless Tibial Base, Uncemented Acetabular Shell
Classification Name and Reference:	21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer
	porous-coated uncemented prosthesis
	Class II
	21 CFR 888.3353 – Prosthesis, hip, semi-constrained,
	metal/ceramic/polymer, cemented or non-porous, uncemented
	Class II
Subject Product Code and Panel Code:	Orthopedics/87/MBH, LZO
	Predicate Device (EVOLUTION® BIOFOAM® Tibial Base, ADVANCE® BIOFOAM® Tibial Base):
	ADVANCE® Spiked Porous Tibial Base (K063128)
Predicate Device (DYNASTY® BIOFOAM® Acetabular Shells):
	DYNASTY® Acetabular System (K122382)
Reference Device:	EVOLUTION® BIOFOAM® Tibial System (K152298)

MicroPort Orthopedics BV Hoogoorddreef 5, 1101 BA Amsterdam, The Netherlands +31 20 545 01 00

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Image /page/4/Picture/0 description: The image shows the logo for MicroPort Orthopedics. The logo features a blue rounded square with a white circle inside, and a red star in the center. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" underneath in red. Below that is the text "Full Function. Faster."

BIOFOAM® Additive Manufacturing Traditional 510(k) 510(k) Summary

DEVICE INFORMATION

A. Intended Use

ADVANCE® BIOFOAM® Tibial Bases and EVOLUTION® BIOFOAM® Tibial Bases

The ADVANCE® BIOFOAM® and EVOLUTION® BIOFOAM® tibial bases are 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:
1. Inflammatory degenerative joint disease, including rheumatoid arthritis;
1. Correction of functional deformity;
1. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants are for cementless use only.

DYNASTY® BIOFOAM® Acetabular Shell

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankyloses, protrusion acetabuli, and painful hip dysplasia;
Inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
1. Correction of functional deformity;
Revision procedures where other treatments or devices have failed. 4.

The DYNASTY® BIOFOAM® Acetabular Shell is for uncemented use only.

B. Device Description

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Image /page/5/Picture/0 description: The image shows the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a red star. To the right of the square is the word "MicroPort" in blue, and below that is the word "Orthopedics" in red. Below that is the phrase "Full Function. Faster."

BIOFOAM® Additive Manufacturing Traditional 510(k) 510(k) Summary

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 device, 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.

D. Nonclinical Testing

The subject BIOFOAM® Additive Manufacturing (BIOFOAM® AM) was evaluated for static shear strength per ASTM F1044 and static tensile strength per ASTM F1147. A shear fatigue evaluation was also conducted per ASTM F1160. An abrasion evaluation was also performed.

Additionally, a stereological evaluation was completed per ASTM F1854.

The results from shear and tensile testing supported the conclusion that the subject BIOFOAM® AM has static shear strength and static tensile strength substantially equivalent to the predicate. The BIOFOAM® AM exhibited a static shear and tensile strength greater that required by the FDA Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement. The shear fatigue evaluation supported the conclusion that the shear fatigue strength of BIOFOAM® AM is substantially equivalent to the predicate. The results of the abrasion evaluation concluded that the subject material performs as well as the predicate and is expected to resist abrasive in vivo forces.

Bacterial Endotoxin Testing (BET) and the following validation activities for additive manufacturing were also performed:

. Validation of the build parameters
Validation of the print chamber (orientation, location)
Validation of the powder recycle ●
Demonstration of residual powder removal .

E. Clinical Testing

Clinical data was not provided for the subject devices.

F. Conclusion

The design features, materials information, predicate testing and analysis date provided in this premarket notification adequately support the substantial equivalence of the BIOFOAM® Additive Manufacturing (BIOFOAM® AM) material for use as an implant porous coating.

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.