The Prime E-CLASS™ XLPE Liner is an acetabular liner intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. This device is indicated for 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; and,
revision procedures where other treatments or devices have failed.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

Device Description

The Prime E-CLASS™ XLPE Liner is an additional liner option for MicroPort Orthopedics' Prime Acetabular Cup System (K170444; K180798). The subject Liner is intended to be used with Acetabular Shells and optional Cancellous Bone Screws as part of a total acetabular system.
The Prime E-CLASS™ XLPE Liner is manufactured from E-CLASS™, a vitamin E blended XLPE, conforming to ASTM F2695-12. The subject Liner is available in Standard, Lipped, and Lateralized/Face-changing configurations. The subject Liner has a two-part locking detail featuring 12 anti-rotational tabs and a lock flange, which is intended to mate with the 12 antirotational pockets and lock groove of the compatible Prime Acetabular Shells (K170444; K180798).

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (Prime E-CLASS™ XLPE Liner), which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, the information required for a table of acceptance criteria and proven device performance as typically expected for a diagnostic AI/ML device is not available in this document. The document describes non-clinical testing performed to establish substantial equivalence for a physical implant, not a software algorithm.

Here's a breakdown of why the requested information cannot be fully provided based on the input text:

Acceptance Criteria & Device Performance: The document does not define specific clinical or diagnostic acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) that the device must meet. Instead, it details non-clinical tests (bacterial endotoxin, mechanical testing, material properties, wear analysis, fatigue, range of motion) to show the device performs similarly to predicate devices. The "reported device performance" are the results of these non-clinical tests, which aim to demonstrate equivalence rather than meeting independent performance criteria.
Study Type: This is a premarket notification (510(k)) for a physical medical implant, not a study of an AI/ML diagnostic or prognostic device. The "study" here refers to non-clinical bench testing and analysis to show equivalence.

Given the nature of the document, most of the requested fields are not applicable or the information is not present.

However, I can extract what is available regarding the "studies" (non-clinical testing) performed:

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

As mentioned, specific acceptance criteria in terms of clinical performance metrics are not provided. The "acceptance criteria" for this 510(k) submission are implied by successful completion of tests demonstrating substantial equivalence to predicate devices. The "reported device performance" refers to the outcomes of these non-clinical tests.

Acceptance Criteria (Implied)	Reported Device Performance
Bacterial endotoxin limit (USP endotoxin limit of 20 EU/device)	Endotoxins found to be less than the USP endotoxin limit of 20 EU/device.
Mechanical performance of lock detail (Push-out, Lever-out, Torque-out, Axial long-term fatigue) per ASTM F1820, ASTM STP1301, FDA Guidance	Testing performed "through Pre- and Post- Fatigue Pushout Lever-out and Torque-out of the subject Liner from a compatible Shell... and testing found in literature." Axial long-term fatigue also evaluated. (Results affirm substantial equivalence, specific numeric results are not provided in this summary.)
Material properties of E-CLASS™ per various ASTM/ISO standards	Considered applicable from K171181 (identical material). (Implies material meets these standards.)
Smooth wear per ASTM F1714-96 (2003), ISO 14242-2, etc.	Considered applicable from K171181 (identical material and articulating surface).
Abrasive wear per ASTM F1714-96 (2003), ISO 14242-3, etc.	Considered applicable from K171181 (identical material and articulating surface).
Wear particle analysis per ASTM F1877-05	Considered applicable from K171181.
Long-term fatigue per FDA Draft Guidance Documents	Considered applicable from K171181.
Deformation and frictional torque per ISO 7206-12	Considered applicable from K171181.
Range of motion per ISO 21535	Considered applicable from K170444 (identical articulating surface and configurations).
Biocompatibility (extractables, cytotoxicity, irritation, sensitization)	Performed for K171181 (identical E-CLASS™ material). (Implies results were acceptable.)
Sterilization residuals per AAMI TIR 28:2009 Annex A	Evaluated. "Sterealization residuals are within the limits determined by the worst case, which was presented in K140043."

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

Sample Size: Not explicitly stated for each non-clinical test. For mechanical tests, standard testing protocols define sample sizes, but these are not enumerated here.
Data Provenance: Not applicable. This refers to bench testing of physical components, not patient 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 clinical data is not relevant to this type of non-clinical device testing.

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

Not applicable. Adjudication is typically for human assessment of images or clinical outcomes, not for mechanical bench testing.

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 not an AI/ML diagnostic device.

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

Not applicable. This is not an AI/ML diagnostic device.

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

For non-clinical testing, the "ground truth" is established by adherence to recognized national and international standards (ASTM, ISO, FDA Guidance) and laboratory measurements using calibrated equipment. For example, the ground truth for endotoxin levels is defined by the USP limit. For mechanical properties, it's the measured values compared to established benchmarks or predicate device performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML diagnostic device, and thus no "training set" of data in that context. The "training" for the device's design comes from engineering principles, material science, and prior designs.

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

Not applicable. No "training set" in the context of AI/ML.

Summary

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September 14, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services logo. To the right of the symbol is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

MicroPort Orthopedics Inc. Sarah Stroupe Sr. Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K181598

Trade/Device Name: Prime E-CLASS XLPE Liner 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: June 15, 2018 Received: June 18, 2018

Dear Sarah Stroupe:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vesa
Vuniqi -S
Digitally signed
by Vesa Vuniqi -S
Date: 2018.09.14
18:13:22 -04'00'

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)

K181598

Device Name Prime E-CLASS™ XLPE Liner

Indications for Use (Describe)

Indications for Use

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.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

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 is the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle with a red diamond shape in the center. To the right of the square is the text "MicroPort" in a large, bold, blue font. Below that is the word "Orthopedics" in a smaller, red font, and below that is the phrase "Full Function. Faster" in a smaller, blue font.

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 Substantial Equivalence for the use of the Prime E-CLASS™ XLPE Liner.

Submitted by:	MicroPort Orthopedics Inc.5677 Airline Rd, Arlington TN, 38002Phone: 866-872-0211Fax: 855-446-2247
Date:	August 30, 2018
Contact Person:	Sarah Evonne StroupeSr. Regulatory Affairs Specialist
Proprietary Name:	Prime E-CLASS™ XLPE Liner
Common Name:	Acetabular Liner
Classification Name and Reference:	21 CFR 888.3353 LZO, OQIHip joint metal/ceramic/polymer semi constrainedcemented or nonporous, uncemented prosthesisClass II
	21 CFR 888.3358 LPH, OQGHip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesisClass II
Subject Product Code and Panel Code:	Orthopedics/87/LZO, LPH, OQG, OQI
Predicate Devices:	PROCOTYL® PRIME E-CLASS™ XLPE Liner(K171181)Prime Acetabular Cup System XLPE Liner(K180798)

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Image /page/4/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 four-pointed star. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Below that is the text "Full Function, Faster" in blue.

Reference Devices:

PROCOTYL® PRIME Acetabular Cup System (K170444) LINEAGE® Acetabular System (K002149 and K052026) DYNASTY® Acetabular System (K002149, K061547, K070785, and K082924)

DEVICE INFORMATION

A. Intended Use

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion 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.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

B. Device Description

The Prime E-CLASS™ XLPE Liner is manufactured from E-CLASS™, a vitamin E blended XLPE, conforming to ASTM F2695-12. The subject Liner is available in Standard, Lipped, and Lateralized/Face-changing configurations. The subject Liner has a two-part locking detail featuring 12 anti-rotational tabs and a lock flange, which is intended to mate with the 12 antirotational pockets and lock groove of the compatible Prime Acetabular Shells (K170444; K180798).

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Image /page/5/Picture/0 description: The image shows 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 blue, with the word "Orthopedics" underneath in red. Below that is the phrase "Full Function, Faster" in blue.

C. Substantial Equivalence Information

The subject Liner's intended use, size range, articulating surface, and available configurations are identical to the predicates K171181 and K180798. The subject Liner's material (E-CLASS™) is identical to the predicate K171181. The subject Liner's geometry is identical to the predicate K180798.

The fundamental scientific technology of the subject Liner has not changed relative to the predicates.

Based on these similarities, the Prime E-CLASS™ XLPE Liner is believed to be substantially equivalent to the predicate devices.

D. Nonclinical Testing

Nonclinical testing performed on the to establish the basis for substantial equivalence of the Prime E-CLASS™ XLPE Liner included bacterial endotoxin testing and mechanical testing of the lock detail.

. Bacterial endotoxin testing was performed per ANSI/AAMI ST72:2011; endotoxins were found to be less than the USP endotoxin limit of 20 EU/device;
. Mechanical testing of the lock detail was performed through Pre- and Post- Fatigue Pushout Lever-out and Torque-out of the subject Liner from a compatible Shell (K170444; K180798) per ASTM F1820, ASTM STP1301, and testing found in literature. Axial long-term fatigue per FDA Draft Guidance Documents "Guidance Document for Testing Acetabular Cup Prostheses" and "Guidance Document for Testing Non-Articulating 'Mechanically-Locked' Modular Implant Components", both issued May 1, 1995, was also evaluated as part of this study.

Due to the subject Liner's identical material and articulating surface, the following testing performed for K171181 is considered applicable:

Material properties of E-CLASS™ per ASTM D1505, ISO 11542-2, ASTM D638, ISO ● 527-3, ASTM D256, ASTM F648, ASTM F2214, ASTM F2138, ASTM F2102-13, ISO 5834-4, ASTM F2381, ASTM F2625, ASTM D3418, ASTM D638, ASTM D695, ISO 5834-3, ISO 5834-5, and ASTM E647;
Smooth wear per ASTM F1714-96 (2003), ISO 14242-2: 2016, ISO 21535: 2007, ISO ● 14242-3:2009, and FDA Guidance "Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices" issued February 12, 2016;
Abrasive wear per ASTM F1714-96 (2003), ISO 14242-3: 2014, ISO 14242-2: 2016, ISO ● 21535: 2007, and ISO 21534: 2007;
Wear particle analysis per ASTM F1877-05; ●

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Image /page/6/Picture/0 description: The image is a logo for MicroPort Orthopedics. The logo features a blue square with rounded corners on the left side, inside of which is a red diamond shape with a white outline. To the right of the square is the text "MicroPort" in a bold, blue font, with the word "Orthopedics" underneath in a red font. Below that is the text "Full Function, Faster" in a blue font.

Long-term fatigue per FDA Draft Guidance Documents "Guidance Document for Testing . Acetabular Cup Prostheses" and "Guidance Document for Testing Non-Articulating 'Mechanically-Locked' Modular Implant Components", both issued May 1, 1995; and,
Deformation and frictional torque per ISO 7206-12. ●

Due to the subject Liner's identical articulating surface and configurations, the following testing performed for K170444 is considered applicable:

Range of motion per ISO 21535 ●

E. Clinical Testing

Clinical data was not necessary to determine substantial equivalence between the Prime E-CLASS™ XLPE Liner and the predicate devices.

F. Biocompatibility

The Prime E-CLASS™ XLPE Liner is manufactured from the identical E-CLASS™ material characterized for the predicate K171181. Intended patient contact also remains identical. Therefore, biocompatibility testing performed for K171181 remains applicable to the subject device. Biocompatibility bench and animal studies used to characterize the E-CLASS™ material included extractables, cytotoxicity, irritation, and sensitization studies.

The Prime E-CLASS™ XLPE Liner is implanted using the same instrumentation cleared within K170444; no new biocompatibility assessment is required.

G. Component and Accessory Compatibility

The Prime E-CLASS™ XLPE Liner is compatible with Prime Acetabular Cup System Shells (K170444; K180798) and Instrumentation (K170444). The Prime E-CLASS™ XLPE Liner is also compatible with previously cleared MicroPort Femoral Heads.

Compatibility of the subject Liner with previously cleared MicroPort Orthopedics is listed in Table 1.

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Image /page/7/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue rounded square with a white circle inside, containing a red star-like shape. To the right of the square is the word "MicroPort" in blue, with "Orthopedics" underneath in red.

Table 1: Prime E-CLASS™ XLPE Liner Compatibility

510(k)	Intended Combinations
with Femoral Heads (up to 44mm)
K893685	Ceramic-Polyethylene with ID 28-36mm**
K920593	Ceramic-Polyethylene, OD 28mm
K925512	Ceramic-Polyethylene, OD 28mm
K932222	Metal-Polyethylene, OD 28mm XXL
K002149	Metal-Polyethylene with ID 22-32mm
K021349*	Metal-Polyethylene with ID 38-56mm
K004043*	Metal-Polyethylene with ID 28-36mm
K051348*	Metal-Polyethylene with ID 38-56mm
K072656	Ceramic-Polyethylene with ID 38-46mm with neck sleeves
K130376	Ceramic-Polyethylene with ID 32-40mm
K140043	Ceramic-Polyethylene with ID 28mm
with Acetabular Shells
K170444	Quad and Solid Acetabular Shells
K180798	Quad and Solid Acetabular Shells
with Instrumentation
K170444	Acetabular Liner Trials

*Metal femoral heads in K021349, K004043 and K051348 were originally cleared for use with metal-metal bearings, and later cleared for compatibility with DYNASTY® A-CLASS® polyethylene liners in K070785.

** 36mm Forte Ceramic heads were originally cleared for use in PMA P030027, and later cleared for compatibility with PROCOTYL® L / O Acetabular System in K142119.

H. Sterilization Residuals

Ethylene Oxide sterilization of the subject Liner was evaluated per AAMI TIR 28:2009 Annex A. The evaluation determined that sterilization residuals are within the limits determined by the worst case, which was presented in K140043 as established by product density, product size, and worst case sterilization conditions.

I. Conclusion

The indications for use and fundamental scientific technology of the Prime E-CLASS™ XLPE Liner are identical to the predicate and reference devices. The subject Liner's geometry is identical to the predicate K180798. The subject Liner's material is identical to the predicate K171181. Additionally, the Prime E-CLASS™ XLPE Liner's compatibility with other components is identical to the predicate liners cleared within K171181 and K180798. The predicate and subject testing and analyses support the substantial equivalence of the Prime E-CLASS™ XLPE Liner's performance.

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.