The Pinnacle Duofix™ HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.

Device Description

The Pinnacle Duofix HA Acetabular Cup Prosthesis is a sintered, porous-coated (Porocoat®) hemispherical outer acetabular shell manufactured from titanium alloy (Ti-6Al-4V) with a thin layer of hydroxyapatite (HA) coating applied.

The interior of the acetabular cup is designed with a groove and a taper for use with either an ultra-high molecular weight polyethylene (UHMWPE) or metal acetabular cup liner, which lock into the shell. Articulation occurs between the liner, and a femoral head with the appropriately sized diameter.

The shells contain an apical threaded hole to allow the surgeon to attach the shell insertion instrument and grasp the shell during implantation. An optional titanium alloy (Ti-6Al-4V) apical hole plug is available to screw into the threaded apical hole of the shell. The plug is intended to occlude the apical hole in order to prevent particulate migration and provide polyethylene support.

The Pinnacle Duofix HA Acetabular Cup Prosthesis is provided in shell diameter sizes 48mm through 66mm in both the "No Hole" (100 series) and the "Cluster Hole" (Sector series) configurations.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Pinnacle Duofix™ HA Acetabular Cup Prosthesis). It describes the device, its intended use, and claims substantial equivalence to previously cleared devices.

However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/software as a medical device (SaMD) submission.

The 510(k) process for this type of implantable device relies on demonstrating substantial equivalence to a predicate device based on similarities in design, materials, manufacturing processes, and intended use. Performance is typically established through non-clinical testing (e.g., mechanical testing, biocompatibility) rather than clinical studies with human participants in the context of diagnostic accuracy.

Therefore, many of the requested categories related to acceptance criteria and study design (especially those pertinent to AI/SaMD) cannot be extracted from this document, as they are not applicable to the type of submission provided.

Here's a breakdown of what can be inferred or directly stated from the document, and what cannot:

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

Not Applicable in this format. This 510(k) summary for an orthopedic implant does not define specific "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or provide a table of such criteria against reported performance as would be seen for an AI/SaMD.
Instead, the "performance" is implicitly deemed acceptable by demonstrating substantial equivalence to a predicate device (Pinnacle Acetabular System, K000306 and TriFlange Acetabular Cup, K001277) based on similarities in design, materials, and intended use. The performance is related to the physical and biological characteristics of the implant, which are assumed to be "met" by being equivalent to the proven predicate.

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

Not applicable. There is no "test set" in the context of clinical diagnostic performance. This device is a physical implant, not a diagnostic tool requiring a test set of data for performance evaluation.

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. This information is irrelevant for a physical orthopedic implant.

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

Not applicable. There is no "test set" or diagnostic adjudication process.

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 an implantable medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is an implantable medical device, not an algorithm.

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

Not applicable. For a physical implant, "ground truth" typically relates to its material properties, mechanical integrity, and biocompatibility, which are assessed through laboratory testing and established standards, not diagnostic outcomes. The "ground truth" for its safety and effectiveness is primarily established through the long-term clinical history and regulatory clearance of its predicate devices.

8. The sample size for the training set

Not applicable. No training set for an algorithm is involved.

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

Not applicable. No training set for an algorithm is involved.

Summary of Relevant Information from the Document:

Device Name: Pinnacle Duofix™ HA Acetabular Cup Prosthesis
Intended Use: Total hip replacement procedures for various conditions (rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, nonunion of femoral fractures, revision arthroplasty, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability due to previous fusion where bone stock is inadequate). Indicated for cementless application.
Basis of "Acceptance" / Substantial Equivalence: Demonstrated through similarities of design, materials, sterilization processes, and the same intended use to:
- Predicate Device 1 (Acetabular Cup): DePuy Pinnacle Acetabular System, K000306
- Predicate Device 2 (HA Porous Coating): DePuy TriFlange Acetabular Cup K001277
Device Performance (Implicit): The device is considered to perform equivalently to its predicate devices due to the demonstrated similarities. The performance of the predicate device (K000306) and the HA coating (K001277) would have established their safety and effectiveness through their prior regulatory clearances, which forms the basis for accepting the current device's performance. This type of submission relies on the existing evidence for the predicate rather than new, extensive clinical studies for the new device unless significant differences are present.

Summary

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JUN 11 2003

K031495- 1

510(k) Summary

NAME OF SPONSOR:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910
510(K) CONTACT:	Karla A. HamSenior Regulatory AssociatePhone: (574) 371-4925FAX: (574) 371-4987
TRADE NAME:	Pinnacle Duofix™ HA AcetabularCup Prosthesis
COMMON NAME:	Acetabular Cup Prosthesis
CLASSIFICATION:	Class II Device per 21 CFR 888.3358:Hip joint metal/polymer/metal semi-constrainedporous coated uncemented prosthesis
DEVICE PRODUCT CODE:	87LPH
SUBSTANTIALLY EQUIVALENTDEVICES:	Acetabular Cup: DePuy Pinnacle AcetabularSystem, K000306HA Porous Coating: DePuy TriFlange AcetabularCup K001277

DEVICE DESCRIPTION:

The Pinnacle Duofix HA Acetabular Cup Prosthesis is provided in shell diameter sizes 48mm through 66mm in both the "No Hole" (100 series) and the "Cluster Hole" (Sector series) configurations.

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Page 2 of 2

510(k) Summary (cont.)

INTENDED USE AND INDICATIONS:

The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.

BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on similarities of design, materials, sterilization processes, and the same intended use, DePuy believes that the Pinnacle Duofix HA Acetabular Cup is substantially equivalent to the previously cleared Pinnacle Acetabular System, K000306.

In addition, DePuy believes that the hydroxyapatite (HA) coating applied to the Pinnacle Duofix HA Acetabular Cup Prosthesis is substantially equivalent to the HA coating applied to the DePuy TriFlange Acetabular Cup, cleared in K001277.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three birds in flight, arranged in a row.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2003

Ms. Karla A. Ham Senior Regulatory Associate Depuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K031495

Trade/Device Name: Depuy Pinnacle Duofix™ HA Acetabular Cup Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained, porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: April 25, 2003 Received: May 14, 2003

Dear Ms. Ham:

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. Karla A. Ham

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 Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ূ长ο 3149/

Pinnacle Duofix™ HA Acetabular Cup Prosthesis Device Name:

Indications for Use:

The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use A

uriam C. Provost

Division of General. Restorative and Neurological Devic

510(k) Number K031495

0800003

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.