The DePuy ASR™ XL Modular Acetabular Cup System is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head and neck.
Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty.
Certain cases of ankylosis.
Porous-coated DePuy ASR™ XL Modular Acetabular Cups are indicated for cementless application.
The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component.
The DePuy ASR™ XL Modular Acetabular Cup System is compatible with DePuy ASR™ femoral components.

Device Description

The subject DePuy ASR™ XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one-piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups.
Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acctabular cups will be compatible with DePuy ASR™ femoral components.
The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The ASR Uni femoral heads (sizes 39mm through 55mm) were cleared in the DePuy ASR™ Modular Acetabular Cup System, K040627.
The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (DePuy ASR™ XL Modular Acetabular Cup System). It focuses on establishing substantial equivalence to previously cleared devices rather than detailing a study with acceptance criteria and device performance as typically seen in diagnostics or AI/software device submissions. Therefore, the requested information cannot be fully extracted from this document in the manner described.

Here's an analysis based on the available text:

Acceptance Criteria and Study Details for DePuy ASR™ XL Modular Acetabular Cup System

The provided document describes a 510(k) premarket notification for a medical device, the DePuy ASR™ XL Modular Acetabular Cup System. This type of submission primarily aims to demonstrate substantial equivalence to devices already legally marketed, rather than presenting a detailed study with specific performance acceptance criteria like those for diagnostic algorithms or AI.

The document indicates that the submission is a "line extension of the acetabular cup components" and that "minor revisions are being made to the Indications for Use and the Instructions for Use (IFU) to minimize the necessity for multiple IFUs and to update the contents to reflect current practice. The subject device does not raise any new issues of safety or effectiveness."

Because this is a Class III implantable device, the "acceptance criteria" largely revolve around demonstrating that the new sizes (64mm-70mm) and slight modifications do not introduce new safety or effectiveness concerns compared to existing predicate devices. This is typically achieved through design analysis, material composition verification, and sometimes mechanical testing, rather than a clinical study comparing performance metrics against specific quantitative targets.

Therefore, most of the specific questions about acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable to this type of regulatory submission and information is not present in the provided text.

Here's what can be extracted:

Table of Acceptance Criteria and Reported Device Performance

Not applicable in the format requested for this type of device and submission. The "acceptance criteria" are implied by the FDA's acceptance of "substantial equivalence" based on similarities in "design, material composition and intended use/indications for use" with predicate devices. No quantitative performance metrics are reported in this summary.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. This submission relies on demonstrating substantial equivalence to predicate devices through design and material comparisons, not a clinical trial with a "test set" in the context of diagnostic performance.
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 / Not provided. No "ground truth" establishment in this context, as it's not a diagnostic or AI device performance study. The "ground truth" for orthopedic implants relates to their long-term clinical performance and safety, which is established over years of post-market surveillance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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 / Not provided. This is an orthopedic implant, not an AI or imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This refers to a medical device's physical components, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. (See point 2).
The sample size for the training set:
- Not applicable / Not provided. There is no "training set" in the context of this device.
How the ground truth for the training set was established:
- Not applicable / Not provided.

In summary: The provided 510(k) summary focuses on regulatory clearance through substantial equivalence, which is a different pathway than studies validating the performance of diagnostic algorithms or AI-powered devices against explicit acceptance criteria. The information requested (table of criteria, sample sizes, expert involvement, etc.) is standard for such performance studies but is not contained within this type of 510(k) documentation.

Summary

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K080991 # '1/3

510(k) Summary (As required by 21 CFR 807.92 and 21 CFR 807.93)

JUL - 2 *2008

NAME OF SPONSOR:	DePuy Orthopaedics, Inc.700 Orthopacdic DriveWarsaw, Indiana 46582Establishment Registration Number: 1818910
MANUFACTURER:	DePuy International LimitedSt. Anthony RoadLeeds, United Kingdom LS11 8DTEstablishment Registration Number: 8010379
510(K) CONTACT:	Dawn SinclairRegulatory Affairs AssociateTelephone: (574) 372-5023Facsimile: (574) 371-4987Electronic Mail: Dsincla3@dpyus.jnj.com
DATE PREPARED:	February 25, 2008
PROPRIETARY NAME:	DePuy ASR™ XL Modular Acetabular CupSystem
COMMON NAME:	Acetabular Cup Prosthesis
CLASSIFICATION:	Class III per 21 CFR 888.3330, Hip jointmetal/metal semi-constrained, with anuncemented acetabular component, prosthesis
DEVICE PRODUCT CODE(S):	87 KWA
SUBSTANTIALLY EQUIVALENTDEVICE(S):	DePuy ASR™ Modular Acetabular Cup System(K040627)DePuy ASR™ 300 Acetabular Cup System(K073413)Wright Medical Metal TRANSCEND®Articulation System (Larger Sizes)(K021349)DePuy Ultima® Unipolar Head and AdapterSleeves (K965156)DePuy ASR™ Taper Sleeve Adapter (K070359)Corail AMT™ Hip Prosthesis (K042992)DePuy Tri-Lock® Bone Preservation Stem(K073570)

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Image /page/1/Picture/1 description: The image shows a handwritten text string that appears to be a combination of letters and numbers. The string reads 'K080991 #2/3'. The text is written in black ink on a white background and has a casual, handwritten style.

DEVICE DESCRIPTION:

Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acctabular cups will be compatible with DePuy ASR™ femoral components.

The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The ASR Uni femoral heads (sizes
39mm through 55mm) were cleared in the DePuy ASR™ Modular Acetabular Cup System, K040627.

The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy.

INDICATIONS AND INTENDED USE:

Indications for Use:

The DePuy ASR™ XL Modular Acetabular Cup System is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head and neck.
1. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty.
1. Certain cases of ankylosis.

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080991 # 3/3

Porous-coated DePuy ASR™XL Modular Acetabular Cups are indicated for cementless application.

Intended Use:

The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component.

The DePuy ASR™ XL Modular Acetabular Cup System is compatible with DePuy ASR™ femoral components.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy ASR" XL Modular Acetabular Cup components described in this submission are, in our opinion, substantially equivalent to those included in the previously cleared DePuy ASR" Modular Acetabular Cup System (K040627); the DePuy ASR" 300 Acetabular Cup System (K073413); the Wright Medical Metal TRANSCEND® Articulation System (K021349); the DePuy ASR™ Adapter Sleeve (K070359); the DePuy Ultima "Adapter Sleeves (K965156); the Corail AMT" Hip Prosthesis (K042992); and the DePuy Tri-Lock® Bone Preservation Stem (K073570), based upon the similarities in design, material composition and intended use/indications for use. A modification is simply being made to add additional cup sizes. In addition, minor revisions are being made to the Indications for Use and the Instructions for Use (IFU) to mininimize the necessity for multiple IFUs and to update the contents to reflect current practice unc subject device does not raise any new issues of safety or effectiventess.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2008

DePuy Orthopaedics, Inc. % Ms. Dawn Sinclair Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K080991

Trade/Device Name: DePuy ASRIM XL Modular Acetabular Cup System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA Dated: March 17, 2008 Received: April 7, 2008

Dear Ms. Sinclair:

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

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Page 2 - Ms. Dawn Sinclair

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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Mark H. Miller

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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Indications for Use Statement

510 (k) Number (if known):	K080991
----------------------------	---------

Device Name:

Indications for Use:

The DePuy ASR™ XL Modular Acetabular Cup System is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head and neck.
1. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty.
1. Certain cases of ankylosis.

Porous-coated DePuy ASR™ XL Modular Acetabular Cups are indicated for cementless application.

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office (Division Sign-Off) (ODE)
(Posted November 13, 2003)
Division of General, Restorative and Neurological Devices	Page 1 of 1
510(k) Number	1080997

Page 14 of 152

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.