The subject Constrained Liner is intended to be used with the DePuy Pinnacle® metal acetabular shells, DePuy Modular M femoral heads and Self-centering™ (bipolar) femoral heads to resurface the acetabular socket in cementless total hip arthroplasty.

The Pinnacle® Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

The Pinnacle® Constrained Acetabular Liner is indicated for use with the Pinnacle® Acetabular Cup in cementless application.

Device Description

The DePuy Pinnacle® Constrained Acetabular Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-6A1-4V). The liner component articulates with a metal femoral head of an appropriate diameter.

The Pinnacle® Constrained Acetabular Liner mechanically constrains the femoral head within the ID of the liner by providing greater than 180 degrees femoral head capture combined with a titanium constraining ring which fits over the opening diameter of the liner. The UHMWPE liner is held in the metal shell by means of a titanium locking ring.

The subject DePuy Pinnacle® Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized facechanging orientation and have inner diameters (ID) compatible with Self-Centering™ (bipolar) femoral heads within the 40mm - 44mm size range. The liners are identical in design to those cleared in K052079 on October 21, 2005. The compatible components are being extended in this submission to include DePuy Modular M femoral heads (cleared in K060031 on January 31, 2006) within the 40mm - 44mm size range.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DePuy Pinnacle® Constrained Acetabular Liner:

The provided 510(k) summary (K071117) does not describe a study to prove acceptance criteria in the traditional sense of a clinical trial or performance study with acceptance metrics. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested fields related to a specific study (sample size, experts, ground truth, MRMC study, standalone performance, training set) cannot be directly extracted from this document, as such a study was not the basis of clearance.

Here's the information that can be gleaned, with explanations for missing parts:

Acceptance Criteria and Study for DePuy Pinnacle® Constrained Acetabular Liner (K071117)

This 510(k) submission (K071117) asserts substantial equivalence to predicate devices rather than presenting a performance study with defined acceptance criteria and tested device performance. The "acceptance criteria" here are implicitly met by demonstrating that the device is identical or substantially similar to previously cleared devices in terms of design, materials, manufacturing, and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Pinnacle® Constrained Acetabular Liner: Identical to previous cleared version (K052079)	The DePuy Pinnacle® Constrained Acetabular Liner described in this submission is identical to the DePuy Pinnacle® Constrained Acetabular Liner previously cleared in K052079 on October 21, 2005. There have been no design modifications to the Pinnacle Constrained Acetabular Liner.
DePuy Modular M Femoral Head (Compatible Component): Identical to previous cleared version (K060031)	The DePuy Modular M femoral head compatible component described in this submission is identical to the DePuy Modular M femoral head previously cleared in K060031 on January 31, 2006. There have been no design modifications to the DePuy Modular M femoral heads.
Articulation of Liner with Modular M Femoral Heads: Substantially equivalent to predicate device (K043058) in design, intended use, material, and manufacturing methods. No new issues of safety or effectiveness due to size differences.	The articulation of the DePuy Pinnacle Constrained Acetabular Liner with the DePuy Modular M femoral heads is substantially equivalent to the predicate device (K043058 cleared on March 14, 2005) based on similarities in design, intended use, material and manufacturing methods. The DePuy Modular M femoral head mating components, while not identical in size to the predicate, do not raise any new issues of safety or effectiveness. DePuy believes that the articulation of the DePuy Pinnacle® Constrained Acetabular Liner and the DePuy Modular M femoral head is substantially equivalent to the previously cleared devices.

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

Not applicable. This submission did not involve a test set for performance evaluation in the typical sense. Substantial equivalence was demonstrated by comparing design specifications and intended use against already cleared devices.

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

Not applicable. No expert ground truth establishment for a test set was described.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication method was described within this summary.

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 physical medical implant (acetabular liner), not an AI/software device that would involve human readers or AI assistance.

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

Not applicable. This is a hardware device; no algorithm-only performance was assessed.

7. The type of ground truth used:

Not applicable. The submission does not refer to ground truth data in the context of a performance study. "Ground truth" in this context is established by the prior clearance of the predicate devices and the demonstration that the current device is identical or substantially equivalent.

8. The sample size for the training set:

Not applicable. This is a hardware device; no training set for an algorithm was used.

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

Not applicable. No training set was used.

Summary Explanation:

The K071117 submission is a 510(k) premarket notification that seeks clearance based on "substantial equivalence." This regulatory pathway allows manufacturers to market a new device if it is as safe and effective as a legally marketed "predicate device." A key aspect of proving substantial equivalence is demonstrating that the new device has the same technological characteristics (or different characteristics that do not raise new questions of safety or effectiveness) and the same intended use as a predicate device.

In this specific case, the applicant states that:

The DePuy Pinnacle® Constrained Acetabular Liner is identical to a previously cleared version (K052079).
The DePuy Modular M femoral head (which the liner is now compatible with) is identical to a previously cleared version (K060031).
The articulation/combination of these two components is substantially equivalent to a different predicate device (K043058) based on similarities in design, intended use, material, and manufacturing.

Therefore, the "acceptance criteria" were met by establishing these direct identifcations or substantial equivalences to already approved devices, rather than through a de novo performance study. The "study" referenced is the comparative analysis against the predicate devices' specifications and clearance information.

Summary

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K071117 pg.123

Section 5–510 (k) Summary

MAY 1 8 2007

(As required by 21 CFR 807.92(c) and 21 CFR 807.93)

NAME OF SPONSOR:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46582Establishment Registration Number: 1818910
510(K) CONTACT:	Natalie HeckManager, Regulatory AffairsTelephone: (574) 372-7469Facsimile: (574) 371-4987Electronic Mail: NHeck@dpyus.jnj.com
510(K) PREPARER:	Rebecca LennardIndependent ContractorElectronic Mail: RLennard@dpyus.jnj.com
DATE PREPARED:	October 16, 2006
PROPRIETARY NAME:	DePuy Pinnacle® Constrained Acetabular Liner
COMMON NAME:	Acetabular Cup Liner
CLASSIFICATION:	Class II per 21 CFR 888.3310, Hip jointmetal/polymer/metal, constrained, cemented oruncemented prosthesis
DEVICE PRODUCT CODE:	87 KWZ
SUBSTANTIALLY EQUIVALENTDEVICE:	DePuy Pinnacle® Constrained Acetabular LinerK052079DePuy Pinnacle® Constrained Acetabular LinerK043058DePuy Modular M Femoral Head, K060031

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DEVICE DESCRIPTION:

INTENDED USE AND INDICATIONS:

Intended Use:

Indications for Use:

The Pinnacle® Constrained Acetabular Liner is indicated for use with the Pinnacle® Acetabular Cup in cementless application.

BASIS OF SUBSTANTIAL EQUIVALENCE:

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The DePuy Pinnacle® Constrained Acetabular Liner described in this submission is identical to the DePuy Pinnacle® Constrained Acetabular Liner previously cleared in K052079 on October 21, 2005. There have been no design modifications to the Pinnacle Constrained Acetabular Liner. The DePuy Modular M femoral head compatible component described in this submission is identical to the DePuy Modular M femoral head previously cleared in K060031 on January 31, 2006. There have been no design modifications to the DePuy Modular M femoral heads.

The articulation of the DePuy Pinnacle Constrained Acetabular Liner with the DePuy Modular M femoral heads is substantially equivalent to the predicate device (K043058 cleared on March 14, 2005) based on similarities in design, intended use, material and manufacturing methods. The DePuy Modular M femoral head mating components, while not identical in size to the predicate, do not raise any new issues of safety or effectiveness.

DePuy believes that the articulation of the DePuy Pinnacle® Constrained Acetabular Liner and the DePuy Modular M femoral head is substantially equivalent to the previously cleared devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping shapes representing different aspects of health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 2007

DePuy Orthopaedics, Inc. % Ms. Natalie Heck Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K071117

Trade/Device Name: DePuy Pinnacle® Constrained Acetabular Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: April 19, 2007 Received: April 20, 2007

Dear Ms. Heck:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Natalie S. Heck

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Buch

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 3 – Ms. Natalie S. Heck

cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ- 410 DGRND D.O. f/t:ELF:afb:5/16/07

OC Numbers:

Division of Enforcement A	240-276-0115
Dental, ENT and Ophthalmic Devices Branch	240-276-0115
OB/GYN, Gastro. & Urology Devices Branch	240-276-0115
General Hospital Devices Branch	240-276-0115
General Surgery Devices Branch	240-276-0115
Division of Enforcement B	240-276-0120
Cardiovascular & Neurological Devices Branch	240-276-0120
Orthopedic, Physical Medicine & Anesthesiology Devices andRadiological Devices	240-276-0120

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Section 4 - Indications for Use Statement

Ko 71117 ---------------------------------------------------------------------------------------------------------------510 (k) Number (if known): __

DePuy Pinnacle® Constrained Acetabular Liner Device Name:

Indications for Use:

The Pinnacle® Constrained Acetabular Liner is indicated for use with the Pinnacle® Acetabular Cup in cementless application.

Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003) Barbara Buehl

Page 1 of 1

(Division Sign-Division of General, Restorative, and Neurological Devices

510(k) Number K071117

1 0

Regulation Number and Section

§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”