1. A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease).
1. Failed previous hip surgery.
1. Dislocation risks.
  PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE Acetabular Cups are intended for cementless applications.

Device Description

The DePuy PINNACLE Dual Mobility Liner is manufactured from cobalt-chrome-molybdenum alloy. The Liner is assembled with a taper locking mechanism to PINNACLE Acetabular Shells. The inner surface of the Dual Mobility Metal Liner articulates with a BI-MENTUM polyethylene mobile bearing head. The Dual Mobility construct is compatible with DePuy metal or ceramic modular femoral heads, for use in total hip arthroplasty.

AI/ML Overview

This document describes the DePuy PINNACLE Dual Mobility Liner, a medical device for total hip replacement. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to a legally marketed predicate device, rather than a novel device requiring extensive clinical trials for efficacy.

Therefore, the requested information regarding acceptance criteria, study outcomes proving device merits, expert number and qualifications, sample sizes for test and training sets, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided directly from this document. This document focuses on demonstrating substantial equivalence through non-clinical testing.

Here's an analysis based on the provided text, addressing the points where information is available or inferable:

1. Table of acceptance criteria and the reported device performance:

The document describes non-clinical tests performed to demonstrate substantial equivalence, implying that the device performance met the standards set by these tests, which serve as "acceptance criteria" in this context.

Acceptance Criteria (Test Performed)	Reported Device Performance
Range of motion (in accordance with ISO 21535:2007 / AMD 2016)	Demonstrated substantial equivalence through testing. (Implies performance within ISO standards)
Verification of product compatibility	Demonstrated substantial equivalence through testing. (Implies successful compatibility)
Standard walking wear testing	Demonstrated substantial equivalence through testing. (Implies wear characteristics comparable)
Jump distance assessment	Demonstrated substantial equivalence through testing. (Implies jump distance comparable)
Mechanical testing (in partial compliance with ASTM F1820)	Demonstrated substantial equivalence through testing. (Implies mechanical properties comparable)
Taper performance testing	Demonstrated substantial equivalence through testing. (Implies taper performance comparable)
Bacterial endotoxin testing (as specified in ANSVAAMI ST72:2011)	Meets the requirements of bacterial endotoxin testing.

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

Sample Size for Test Set: Not explicitly stated. The "tests" mentioned are non-clinical, likely involving a specific number of device units or components, but this number is not provided.
Data Provenance: Not explicitly stated but inferred to be internal laboratory testing results conducted by DePuy Ireland UC or its affiliates. The tests are "non-clinical" and do not involve human subjects or retrospective/prospective patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable/provided as the study is a non-clinical, in-vitro (e.g., mechanical, wear) testing study comparing device characteristics to established standards and predicate devices. There is no "ground truth" established by human experts in the way clinical studies would for diagnostic performance.

4. Adjudication method for the test set:

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies with human assessors to resolve discrepancies in diagnoses or assessments. For non-clinical, objective performance tests, the results are typically quantitative and directly measured against predefined criteria.

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:

This information is not applicable. This device is a hip implant, not an AI-powered diagnostic tool, and therefore MRMC studies are irrelevant.

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

This information is not applicable. This device is a hip implant, not an algorithm.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" would be the established scientific and engineering standards (e.g., ISO 21535:2007, ASTM F1820, ANSVAAMI ST72:2011) and the performance characteristics of the legally marketed predicate devices (Stryker Modular Dual Mobility Liner (K103233) and BI-MENTUM Dual Mobility System (K181744)). The tests aim to show that the subject device performs similarly or meets the same safety and performance requirements as these benchmarks.

8. The sample size for the training set:

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. As per point 8, there is no training set for this type of device submission.

Summary

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

September 11, 2020

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

DePuy Ireland UC % Melissa Cook Regulatory Affairs Specialist III DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw. Indiana 46582

Re: K200854

Trade/Device Name: DePuy PINNACLE Dual Mobility Liner Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, LZO, MEH Dated: August 10, 2020 Received: August 12, 2020

Dear Melissa Cook:

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/cdrh/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

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

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K200854

Device Name

DePuy PINNACLE Dual Mobility Liner

Indications for Use (Describe)

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease).
1. Failed previous hip surgery.
1. Dislocation risks.

PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE Acetabular Cups are intended for cementless applications.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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}------------------------------------------------

510(K) SUMMARY

(As required by 21 CFR 807.92)

Submitter Information
Name	DePuy Ireland UC
Address	LoughbegRingaskiddyCo. Cork, Ireland
Phone number	574-453-7014
Establishment RegistrationNumber	3015516266
Name of contact person	Melissa Cook
Date prepared	March 27, 2020
Name of device
Trade or proprietary name	DePuy PINNACLE Dual Mobility Liner
Common or usual name	Total hip joint replacement prosthesis
Classification name	Hip joint metal/polymer/metal semi-constrained porous-coated uncementedprosthesisHip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	21 CFR 888.3358, 888.3353
Product Code(s)	LPH, LZO, MEH
Legally marketed device(s) towhich equivalence is claimed	Stryker Modular Dual Mobility (MDM) Liner (K103233, cleared February 3,2011)Reference device: BI-MENTUM Dual Mobility System (K181744, clearedDecember 11, 2018)
Reason for 510(k) submission	The subject devices are an addition to the DePuy PINNACLE Acetabularimplant portfolio, to provide a dual mobility construct for total hiparthroplasty.
Device description	The DePuy PINNACLE Dual Mobility Liner is manufactured from cobalt-chrome-molybdenum alloy. The Liner is assembled with a taper lockingmechanism to PINNACLE Acetabular Shells. The inner surface of the DualMobility Metal Liner articulates with a BI-MENTUM polyethylene mobile
	bearing head. The Dual Mobility construct is compatible with DePuy metalor ceramic modular femoral heads, for use in total hip arthroplasty.
Intended Use	The PINNACLE Dual Mobility Metal Liners are designed to provideadditional stability where there is an unstable joint and are for use in total hiparthroplasty which is intended to provide increased patient mobility andreduce pain by replacing the damaged hip joint articulation in patients wherethere is evidence of sufficient sound bone to seat and support thecomponents.The PINNACLE Dual Mobility Metal Liners are intended for single use only.
Indications for use	Total hip replacement or hip arthroplasty is indicated in the followingconditions:
	1. A severely painful and/or disabled joint (typically due to noninflammatory degenerative joint disease).2. Failed previous hip surgery.3. Dislocation risks.
	PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLEAcetabular Cups are intended for cementless applications.

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

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

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THEPREDICATE DEVICE
Characteristics	Subject Device:DePuy PINNACLE Dual MobilityInsert	Predicate Device:Stryker Modular Dual MobilityMetal Liner(K103233)	Reference Device:BI-MENTUM Dual MobilitySystem(K181744)
Intended Use	The PINNACLE Dual Mobility MetalLiners are designed to provide additionalstability where there is an unstable jointand are for use in total hip arthroplastywhich is intended to provide increasedpatient mobility and reduce pain byreplacing the damaged hip jointarticulation in patients where there isevidence of sufficient sound bone to seatand support the components.The PINNACLE Dual Mobility MetalLiners are intended for single use only.	Total hip arthroplasty	Total hip replacement
Liner Material	Cobalt-chrome-molybdenum alloy liner	Cobalt-chrome-molybdenumalloy liner	N/A – Device does notincorporate a modular liner
Design	Modular dual articulation	Modular dual articulation	Monoblock dual articulation
CompatibleAcetabularShells	Porous Ti6Al4V Shells, sizes 48mm –72mm	Porous Ti6Al4V Shells, sizes44mm – 80mm	Stainless steel Shells withcommercially pure titanium andhydroxyapatite coating, sizes41mm – 69mm
CompatibleMobileBearing Heads	UHMWPE mobile bearing heads,22.2mm and 28mm IDs	UHMWPE mobile bearing heads,22.2mm and 28mm IDs	UHMWPE mobile bearing heads,22.2mm and 28mm IDs
Sterile Method	Gamma	Gamma	Gamma
Packaging	Double PETG blister with Tyvek peel lid	Double PETG blister with Tyvekpeel lid	Shells: Double PETG blister withTyvek peel lidMobile bearing heads: Vacuum-packed in bags and sealed inblister packaging
Shelf Life	10 years	5 years	5 years

{6}------------------------------------------------

The subject PINNACLE Dual Mobility Metal Liner has the same intended use, design, and material as the predicate Stryker Modular Dual Mobility Metal Liner (K10323). The subject device is intended for total hip arthroplasty; is a modular dual articulation construct; is made of cobalt-chromium-molybdenum alloy; and is available in the same as the predicate device. The subject PINNACLE Dual Mobility Metal Liner has the same intended use and is compatible with the same UHMWPE Mobile Bearing Heads as the reference device BI-MENTUM Dual Mobility System (K181744).

{7}------------------------------------------------

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The following tests were performed on the PINNACLE Dual Mobility Metal Liner to demonstrate substantial equivalence of safety and efficacy with the predicate devices:

Range of motion in accordance with ISO 21535:2007 / AMD 2016 .
Verification of product compatibility ●
Standard walking wear testing .
Jump distance assessment .
Mechanical testing in partial compliance with ASTM F1820 ●
Taper performance testing ●
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSVAAMI ST72:2011 ●

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

No clinical tests were conducted to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject PINNACLE Dual Mobility Metal Liners are substantially equivalent to the predicate Stryker Modular Dual Mobility Metal Liner.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.