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

The PROFEMUR® Preserve Classic 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 PROFEMUR® Preserve Classic Stems are monolithic femoral components manufactured from a forged titanium alloy (ASTM F620). The hip stems are designed for use in cementless total hip arthroplasty and possess identical indications for use to the predicates (K112080). The design features of the PROFEMUR® Preserve Classic Stems are summarized below:

. Stems are forged from Ti6Al4V alloy conforming to ASTM F620
Stems possess unalloyed titanium plasma coating manufactured from powder ● conforming to ASTM F1580
. Neck offsets are offered in Straight and Varus 8 options
Stems are offered in twelve sizes for both neck offsets ●

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the PROFEMUR® Preserve Classic Stem, which is a hip joint prosthesis. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in terms of performance in patients.

Therefore, many of the requested categories (such as sample size for test/training sets, involvement of experts for ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. This document describes mechanical testing and material equivalence, not clinical performance metrics.

Here's a breakdown of what can be inferred or directly stated from the provided text based on your request:

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

Since this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence through mechanical testing, material specifications, and design features that are comparable to a predicate device. There are no explicit clinical performance "acceptance criteria" stated in terms of patient outcomes or diagnostic accuracy, as is common for AI/diagnostic device studies.

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Range of motion in accordance with ISO 21535	Evaluated in accordance with ISO 21535. (Implied successful evaluation, as no adverse findings are noted, and substantial equivalence is claimed).
Proximal fatigue testing according to ISO 7206-6	Successfully evaluated by proximal fatigue testing according to ISO 7206-6.
Distal fatigue testing (applicability to ISO 7206-4 for similar geometry)	Verified to be applicable to ISO 7206-4 distal fatigue testing that was performed on a modular stem possessing a similar geometry. (Implied successful performance by comparison to a validated model and similar device, supporting substantial equivalence).
Materials compliance (Ti6Al4V alloy)	Stems are forged from Ti6Al4V alloy conforming to ASTM F620. Subject devices are made from an identical titanium alloy (ASTM F620) to the predicate devices.
Coating material compliance (unalloyed titanium plasma coating)	Stems possess unalloyed titanium plasma coating manufactured from powder conforming to ASTM F1580. Possess an identical titanium plasma spray coating design specification and material (ASTM F1580 powder) to the predicate device. Coating process and vendor information are identical to those provided for reference device K123688.
Design features (e.g., neck offsets, sizes)	Neck offsets are offered in Straight and Varus 8 options. Stems are offered in twelve sizes for both neck offsets. Designed to provide geometric sizing options that resemble a subset of those available with the predicate device.
Functional Performance (Implication from mechanical testing)	Successful results of testing support the expectation that the device will perform as intended under normal physiological loading conditions.
Substantial Equivalence to Predicate Device (K112080) for intended use and indications	Intended use and indications for use are identical to predicate devices (K112080). Materials and fundamental scientific technology are identical to predicate. Safety and effectiveness are adequately supported by substantial equivalence information.

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

Test Set Sample Size: Not applicable. The "test set" here refers to mechanical samples of the device, not patient data. The document does not specify the number of hip stems tested for fatigue or range of motion, but refers to "stems" (plural).
Data Provenance: Not applicable in the context of clinical data. The testing described is mechanical, under laboratory conditions, using prototypes or production samples of the device.

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" in this context would typically refer to clinical diagnoses or outcomes. This submission focuses on engineering and material specifications, with testing against international standards (ISO, ASTM). The "ground truth" for mechanical testing is established by these standards themselves and the measured physical properties of the device components.

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

Not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth from patient data. For mechanical testing, results are typically determined by measurement against predefined specifications in a standard.

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 device is a hip implant, not an AI-powered diagnostic or decision support tool. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

Not applicable. This device does not involve an algorithm.

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

The "ground truth" for this submission is based on:

International Standards: e.g., ISO 21535 (range of motion), ISO 7206-6 (proximal fatigue), ISO 7206-4 (distal fatigue), ASTM F620 (titanium alloy), ASTM F1580 (titanium powder).
Material Specifications: Chemical composition and mechanical properties of the raw materials and finished components.
FEA Models: Finite Element Analysis models that were previously validated in another submission (K141235) were used for comparison.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.

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

MicroPort Orthopedics. Incorporated Mr. Matt Paul Regulatory Affairs Project Manager 5677 Airline Road Arlington, Tennessee 38002

April 10, 2015

Re: K150302 Trade/Device Name: PROFEMUR® Preserve Classic Stem 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 Dated: February 5, 2015 Received: February 6, 2015

Dear Mr. Paul:

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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Page 2 - Mr. Matt Paul

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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/ResourcesforYou/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,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K150302 (page 1/1)

Device Name PROFEMUR® Preserve Classic Stem

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,
revision procedures where other treatments or devices have failed.

The PROFEMUR® Preserve Classic 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)

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Image /page/3/Picture/1 description: The image shows the logo and contact information for MicroPort Orthopedics. The logo features the company name in blue text with a red star in a blue square. Below the logo is the company's address, which is 5677 Airline Road, Arlington, TN 38002, and their website, ortho.microport.com.

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 PROFEMUR® Preserve Classic Stems.

Submitted by:	MicroPort Orthopedics Inc.5677 Airline Rd, Arlington TN, 38002Phone: 901-867-4350Fax: 901-451-6018
Date:	February 5, 2015
Contact Person:	Matt PaulRequlatory Affairs Project Manager
Proprietary Name:	PROFEMUR® Preserve Classic Stem
Common Name:	Hip Stem
Classification Name and Reference:	888.3353 LZO Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous, uncemented prosthesis -Class II
Subject Product Code and Panel Code:	Orthopedics/87/ LZO
Predicate Device:	PROFEMUR® Preserve Stem (K112080)
Reference Devices:	DYNASTY® Biofoam Shell (K122382)PROFEMUR® TL Classic Hip Stem (K123688)PROFEMUR® TL Classic Long Neck Hip Stems (K140676)

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l. Device Description

. Stems are forged from Ti6Al4V alloy conforming to ASTM F620
Stems possess unalloyed titanium plasma coating manufactured from powder ● conforming to ASTM F1580
. Neck offsets are offered in Straight and Varus 8 options
Stems are offered in twelve sizes for both neck offsets ●

II. Indications for Use

Identically to the predicate, the PROFEMUR® Preserve Classic 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:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular 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 Classic Stems are single use components, intended for use in uncemented total hip arthroplasty.

PROFEMUR® Preserve Classic is intended for use with the sterile compatible components listed in Table 1 below, identical to the predicate.

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	Table 1. Compatible Components
510(k)	Intended Combinations
Modular Femoral Neck Sleeves
K072656	Short to X-long neck sleeves to use with ceramic-polyethylene with ID 38-46mm
Modular Femoral Heads
K953025	Metal-Polyethylene, OD 28mm XXL
K932222	Metal-Polyethylene, OD 28mm
K920593	Ceramic-Polyethylene, OD 28mm
K925512	Ceramic-Polyethylene, OD 28mm
K893685	Ceramic-Polyethylene with ID 28-36mm
K002149	Metal-Polyethylene with ID 22-36mm, OD 42-68mm
K051348	Metal-Polyethylene with ID 36-56mm
K072656	Ceramic-Polyethylene with ID 38-46mm
Acetabular Shell and Inserts
K002149	Metal-Poly with ID 22-36mm, OD 42-68mm
K043073	Metal-Polyethylene and Ceramic-Polyethylene with ID 22-36mm, OD 46-68mm
K043099	Metal-Polyethylene and Ceramic-Polyethylene with ID 22-36mm, OD 46-68mm
K052026	Metal-Polyethylene and Ceramic-Polyethylene with ID 28-36mm
K061547	Metal-Polyethylene with ID 32-42mm, OD 50-58mm
K070785	Metal-Polyethylene and Ceramic-Polyethylene with ID 28-46mm, OD 46-68mm
K082924	Metal-Polyethylene with ID 28-54mm, OD 46-76mm
K122382	Metal-Polyethylene with OD 46-76 mm

III. Nonclinical Testing

The subject PROFEMUR® Preserve Classic Stems were evaluated for range of motion in accordance with ISO 21535. The stems were also successfully evaluated by proximal fatigue testing according to ISO 7206-6. The subject stems were verified to be applicable to ISO 7206-4 distal fatigue testing that was performed on a modular stem possessing a similar geometry. The FEA models used in comparison were previously validated in testing submitted in K141235. Successful results of testing support the expectation that the device will perform as intended under normal physiological loading conditions, and support the substantial equivalence of the PROFEMUR® Preserve Classic Stem.

IV. Clinical Testing

Clinical data was not provided for the subject devices.

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V. Technological Characteristics

The PROFEMUR® Preserve Classic Stems are designed to provide geometric sizing options that resemble a subset of those available with the predicate device. Furthermore, the subject devices are made from an identical titanium alloy (ASTM F620) and possess an identical titanium plasma spray coating design specification and material (ASTM F1580 powder) to the predicate device. Coating process and vendor information are identical to those provided for reference device K123688.

For all associated instruments that do contain colorants, detailed color additive information was provided for the same instruments in K140676.

VI. Substantial Equivalence Information

The intended use and indications for use of the PROFEMUR® Preserve Classic Stems are identical to those of the predicate devices (K112080). The materials of the subject devices are identical to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to that of the predicate devices. 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. For more details on subject and predicate comparison, see the comparison table located in the Device Description (Tab 014).

VII. Conclusion

The design features, subject and predicate testing, materials information, and analysis data provided in this premarket notification adequately support the substantial equivalence of the PROFEMUR® Preserve Classic Stem.

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.