The PROFEMUR® Preserve Sizes 1-3 Hip Stems are intended 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, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and,
4, revision procedures where other treatments or devices have failed
The PROFEMUR® Preserve Sizes 1-3 Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

Device Description

The purpose of this submission is to provide additional sizing options for the predicate PROFEMUR® Preserve Hip Stems (K112080) by adding a line extension. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are modular stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are available in three configurations and are coated with titanium plasma spray conforming to ASTM F1580.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for the PROFEMUR® Preserve Sizes 1-3 Hip Stems. It details the device's substantial equivalence to a predicate device and includes information on nonclinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria	Reported Device Performance
Proximal Fatigue Test (according to ISO 7206-4)	Satisfied the acceptance criteria of the standard.
Distal Fatigue Test (according to ASTM F2068)	Satisfied the acceptance criteria of the standard.
Range of Motion Evaluation (according to ISO 21535)	Satisfied the acceptance criteria of the standard.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify the exact sample sizes (number of devices tested) for the nonclinical tests (proximal fatigue, distal fatigue, range of motion). The studies were nonclinical (laboratory-based mechanical testing), not human clinical studies, so provenance in terms of country of origin or retrospective/prospective is not applicable.

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):

This question is not applicable to this submission. The "ground truth" for the nonclinical testing of a hip stem involves established engineering and materials science standards (ISO, ASTM). The "experts" in this context would be the engineers and technicians performing the tests and comparing results against the specified standards. Their qualifications are inherent in their ability to conduct these specific standardized tests. No medical experts (like radiologists) were involved in establishing "ground truth" for this type of device.

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

This question is not applicable to the nonclinical engineering tests performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where subjective interpretation or classification by multiple experts is required for establishing ground truth, especially in image analysis or disease diagnosis. For mechanical testing, the results are objective measurements against defined pass/fail criteria in the standards.

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:

No MRMC comparative effectiveness study was done. This type of study is relevant for devices involving human interpretation of data, often with AI assistance (e.g., AI for radiology). The PROFEMUR® Preserve Sizes 1-3 Hip Stems are a mechanical implant, and the testing described is nonclinical mechanical testing, not a study of human reader performance.

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

No standalone (algorithm only) performance study was done. This type of study is relevant for AI/software devices. The device is a physical hip stem, and its performance is evaluated through mechanical bench testing, not algorithmic performance.

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

The "ground truth" for the nonclinical testing of the PROFEMUR® Preserve Sizes 1-3 Hip Stems was established by recognized international and national standards for orthopedic implants. Specifically:

ISO 7206-4 for proximal fatigue.
ASTM F2068 for distal fatigue.
ISO 21535 for range of motion.

These standards define the test methodologies and acceptance criteria (e.g., number of cycles survived at a certain load without failure) against which the device's performance is measured.

8. The sample size for the training set:

This question is not applicable. There was no "training set" as this device is a mechanical implant subjected to nonclinical testing, not a machine learning or AI algorithm that requires training data.

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

This question is not applicable as there was no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, composed of three wavy lines forming a profile.

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

April 20, 2015

MicroPort Orthopedics, Incorporated Mr. Byron Ledbetter Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K150133

Trade/Device Name: PROFEMUR® Preserve Sizes 1-3 Hip Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, JDI, LPH, MBL Dated: December 23, 2014 Received: January 21, 2015

Dear Mr. Ledbetter:

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

{1}------------------------------------------------

(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,

Lori A. Wiggins -S

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K150133 (pg 1/1)

Device Name PROFEMUR® Preserve Sizes 1-3 Hip Stems

Indications for Use (Describe)

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and,

4, revision procedures where other treatments or devices have failed

The PROFEMUR® Preserve Sizes 1-3 Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

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

2 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

PROFEMUR® Preserve Sizes 1-3 Hip Stems 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 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® Renaissance® Classic Long Neck Hip Stems.

Submitted by:	MicroPort Orthopedics Inc.5677 Airline RdArlington, TN 38002Phone: (866) 872-0211Fax: (855) 446-2247
Date:	December 23, 2014
Contact Person:	Byron LedbetterRegulatory Affairs Specialist II
Proprietary Name of Modified Device:	PROFEMUR® Preserve Sizes 1-3 Hip Stems
Common Name:	Femoral Hip Stem
Classification Name and Reference:	888.3353 LZOHip joint metal/ceramic/polymer semiconstrained cemented or nonporous,uncemented prosthesisClass II

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with a white circle inside, and a red diamond shape in the center of the circle. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red underneath. Below the logo is the text "MicroPort Orthopedics Inc." in black.

PROFEMUR® Preserve Sizes 1-3 Hip Stems Traditional 510(k) 510(k) Summary

888.3350 JDI Hip joint metal/polymer semi-constrained cemented prosthesis Class II

888.3358 LPH Hip joint metal/polymer/metal semi-Constrained porous-coated uncemented prosthesis Class II

888.3358 MBL Hip joint metal/polymer/metal semi-Constrained poruous-coated uncemented prosthesis Class II

Subject Product Code and Panel Code:

Predicate Devices:

PROFEMUR® Preserve Hip Stems, K112080

Orthopedics/87/LZO/JDI/LPH/MBL

Device Description

Intended Use

The PROFEMUR® Preserve Sizes 1-3 Hip Stems are 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 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed.

The PROFEMUR® Preserve Sizes 1-3 Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the word "MicroPort" in a large, bold, blue font, with the word "Orthopedics" in a smaller, red font underneath it. Below the logo is the text "MicroPort Orthopedics Inc." in a smaller, black font.

Technological Characteristics of the Device

The indications for use of the PROFEMUR® Preserve Sizes 1-3 Hip Stems are identical to those for the predicate device (K112080). The subject devices are made from an identical titanium alloy (ASTM F620) and possess an identical titanium plasma spray coating (ASTM 1580) as the predicate device. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are designed to provide geometry which is similar to those available with the predicate device.

Nonclinical Testing

The PROFEMUR® Preserve Sizes 1-3 Hip Stems were evaluated by proximal and distal fatigue tests in accordance with ISO 7206-4 and ASTM F2068. The devices satisfied the acceptance criteria of each standard.

Range of motion was evaluated and satisfied the acceptance criteria of ISO 21535.

Clinical Testing

Clinical data was not provided for the subject devices.

Conclusions

The indications for use and fundamental scientific technology of the PROFEMUR® Preserve Sizes 1-3 Hip Stems are identical to those of the predicate device. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The safety and effectiveness of the PROFEMUR® Preserve Sizes 1-3 Hip Stems is adequately supported by the substantial equivalence information, materials information, and nonclinical testing data provided within this premarket notification.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.