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

All Pinnacle porous-coated acetabular shells are indicated for cementless application.

Device Description

The Pinnacle Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (Ti-6Al-4V) and a liner manufactured from ultra high molecular weight polyetheylene (UHMWPE), which locks into the outer shell. The liner component articulates with a femoral head of an appropriate diameter.

AI/ML Overview

This document, K001534, is a 510(k) premarket notification for the Pinnacle Acetabular System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a novel AI/software device.

Therefore, much of the requested information regarding acceptance criteria, study methodologies, ground truth establishment, sample sizes, and expert involvement is not present in this document because it outlines a regulatory submission for a medical device (an acetabular cup prosthesis) and not an AI or diagnostic software. The "basis of substantial equivalence" is the key here, not a performance study against acceptance criteria.

However, based on the provided text, I can infer and state what is available and what is explicitly not available.

Acceptance Criteria and Study for K001534: Pinnacle Acetabular System

This 510(k) submission (K001534) for the DePuy Orthopaedics Pinnacle Acetabular System is primarily focused on demonstrating substantial equivalence to a predicate device (K000306), rather than presenting a performance study against a predefined set of quantitative acceptance criteria in the context of an AI or diagnostic device.

The "acceptance criteria" in this context refer to the characteristics and performance aspects that allowed the device to be considered substantially equivalent to a legally marketed predicate device. The "study" proving this largely relies on comparisons of design, materials, manufacturing, and intended use as described below.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance (as stated in submission)
Intended Use: For total hip replacement, similar indications.	The Pinnacle Acetabular System has the "same intended use" as the acetabular cup liners cleared in K000306, including indications for osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, traumatic fracture, failed previous hip surgery, and ankylosis.
Material: Same material composition.	The Pinnacle Acetabular System uses the "same material" (titanium alloy Ti-6Al-4V for the shell, UHMWPE for the liner) as the predicate device.
Method of Manufacture: Similar manufacturing processes.	The Pinnacle Acetabular System uses the "same method of manufacture" as the predicate device.
Design: Similar design principles/features.	The Pinnacle Acetabular System has the "same design" (modular system with porous coated hemispherical outer shell and UHMWPE liner) as the predicate device.
Sterilization & Packaging: Similar methods.	The Pinnacle Acetabular System uses the "same sterilization and packaging methods" as the predicate device.
Overall Performance & Safety: Adequate performance.	The Pinnacle Acetabular System "demonstrated adequate performance in design control activities."

The following information is NOT available in the provided document:

2. Sample size used for the test set and the data provenance: Not applicable. This is a submission for an implantable device, not an AI/software. There is no "test set" of data in the sense of patient images or specific clinical outcomes data analyzed in this document for algorithm performance. The "test" here refers to demonstrating physical characteristics and equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic software is not relevant here. The ground truth for the device's physical properties and performance would be established through engineering testing and material science, not clinical expert consensus on diagnostic data.

4. Adjudication method for the test set: Not applicable for the reasons stated above.

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 an orthopedic implant, not an AI / diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an orthopedic implant, not an algorithm.

7. The type of ground truth used: For this device, the "ground truth" would relate to the physical and chemical properties of the materials, the mechanical performance (e.g., wear, fatigue, pull-out strength), and biocompatibility, as evaluated through engineering design controls and established predicate device performance. It is not expert consensus, pathology, or outcomes data in the context of diagnostics.

8. The sample size for the training set: Not applicable. This device is an orthopedic implant; there is no "training set" in the machine learning sense.

9. How the ground truth for the training set was established: Not applicable for the reasons stated above.

Summary

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K001534

DO Boy 088

SUMMARY OF SAFETY AND EFFECTIVENESS ePuy Orthopaedics, Inc.

NAME OF FIRM:	DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988	PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 USA Tel: +1 (219) 267 8143 Fax: +1 (219) 267 7196
510(k) CONTACT:	Lynnette Whitaker Manager, Regulatory Affairs
TRADE NAME:	Pinnacle Acetabular System
COMMON NAME:	Acetabular Cup Prosthesis
CLASSIFICATION:	888.3358 Hip joint metal/polymer semi-constrained cementless prosthesis
DEVICE PRODUCT CODE:	87 LPH
SUBSTANTIALLY EQUIVALENT DEVICES:	Pinnacle Acetabular System

DEVICE DESCRIPTION AND INTENDED USE:

The Pinnacle Acetabular System is indicated for total hip replacement in the following conditions:

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 or neck.
1. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

JUN 1 2 2000

All Pinnacle porous-coated acetabular shells are indicated for cementless application.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Pinnacle Acetabular System has the following similarities to the acetabular cup liners that were cleared in K000306: same intended use; same material; same method of manufacture; same design; same sterilization and packaging methods. The Pinnacle Acetabular System demonstrated adequate performance in design control activities.

000000

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or feathers, and a human profile in the negative space between the lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2000

Ms. Lynnette Whitaker Group Leader, Regulatory Affairs Depuy Orthopedics, Inc. P.O. Box 988 700 Orthopedic Drive Warsaw. Indiana 46581-0988

Re: K001534

Trade Name: Pinnacle Acetabular System Regulatory Class: II Product Code: LPH Dated: May 11, 2000 Received: May 17, 2000

Dear Ms. Whitaker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Lynnette Whitaker

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and 11 you desire specific days of the diagnostic devices), please contact the Office of Compliance at additionally 607.10 for questions on the promotion and advertising of your device, (301) 594-4639. Tructionally, 101 quest at (301) 594-4639. Also, please note the regulation prease contact the Office or Compilance an (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibilities and more (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html" .

Sincerely yours,

Dune R. Lochner

Image /page/2/Picture/4 description: The image contains a handwritten symbol that resembles a combination of the letters 'G' and 'S'. The symbol is drawn with a continuous line, forming a loop at the top and a curve at the bottom. The symbol is simple and abstract, with no additional details or context provided.

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) _ Koo $534

Device Name Pinnacle Acetabular System

Indications for Use:

The DePuy Pinnacle Acetabular System is intended to resurface the acetabular socket in cemented or cementless total hip arthroplasty.

The Pinnacle Acetabular System is indicated for total hip replacement in the following conditions:

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

All Pinnacle porous-coated acetabular shells are indicated for cementless application.

Concurrence of CDRH, Office of Device Evaluation

Donna R. Jochner.

(Division Sign-Off) (Division Sign-On)
Division of General Restorative Devices Division of Section 534

Prescription Use y a (Per 21 CFR 801.109)

Over-The Counter Use _ No

000004

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.