The ESKA Modular Total Hip System Acetabular Components are indicated for uncemented use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and posttraumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries.

Device Description

The ESKA Modular Hip System Acetabular Components are modular components used in conjunction with the company's femoral stems, for the replacement of severely disabled hip joints. The system consists of porous acetabular shells, modular femoral heads, and modular acetabular liners. The acctabular components are porous coated hemispherical shells with modular UHMWPE inserts.

Materials: The devices are manufactured from CoCrMo alloy, Ultra High Molecular Weight Polyethylene ( UHMWPE ), per ASTM and ISO standards.

Function: The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma.

AI/ML Overview

This document is a 510(k) summary for a medical device (ESKA Modular Hip System Acetabular Components) seeking market clearance, not a study report proving device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment is not available in these provided pages.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the basis for 510(k) clearance. It does not present a performance study with acceptance criteria in the way a clinical trial or a standalone algorithm validation study would.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

Not Applicable. This document does not describe specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or durability thresholds) for device performance. The "acceptance" in a 510(k) is primarily about demonstrating substantial equivalence to a predicate device based on design, function, material, and intended use, rather than meeting quantitative performance benchmarks from a specific study against a set of newly defined acceptance criteria.
The document states: "There are no significant differences between the ESKA Modular Hip System Acetabular Components and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material, and intended use." This statement is the core "performance" claim in the context of a 510(k) for this type of device – i.e., its performance is expected to be equivalent to safely marketed devices.

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. No explicit "test set" or performance study data is described in these pages. This is a premarket notification, not a report of a clinical or technical performance study.

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

Not Applicable. No test set or ground truth establishment process is described.

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

Not Applicable. No test set or adjudication process is described.

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 acetabular component for total hip replacement, not an AI or imaging diagnostic 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 mechanical implant, not software or an algorithm.

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

Not Applicable. No ground truth is established for a performance study in this document. Substantial equivalence relies on comparing the device's characteristics (materials, design, intended use) to those of existing, legally marketed predicate devices.

8. The sample size for the training set:

Not Applicable. This device is a mechanical implant, not a machine learning model, so there is no training set in this context.

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

Not Applicable. As above, no training set.

In summary: The provided text is a regulatory submission for premarket clearance (510(k)) that focuses on establishing substantial equivalence of a medical implant to existing devices. It does not contain information about a specific performance study with acceptance criteria, sample sizes, expert involvement, or ground truth generation, as would be expected for, for example, a diagnostic device or a drug.

Summary

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Summary of Safety and Effectiveness

for

ESKA Modular Hip System Acetabular Components

This safety and effectiveness summary for the ESKA Modular Hip System Acetabular Components is provided as required per Scction 513(i)(3) of the Food, Drug and Cosmetic Act.

MAR 0 4 2003

1. Submitter :	Contact Person :
ESKA Implants GmbH & Co.	Thomas P. Monkus
Grapengießerstraße 34	ESKA America Corporation
D-23556 Lübeck, Germany	101 Riverfront Blvd., Suite 600
(49) 451 89000-0	Bradenton, FL 34205Telephone: (941) 744-5400

Date Prepared: February 25, 2003

Tradename : ESKA Modular Hip System Acetabular Components Common Name : Total Hip System Classification Name : Hip joint metal /polymer/ metal semi-constrained porous uncemented prosthesis ( 888.3358 )

3. Predicate or legally marketed devices which are substantially equivalent :

. PFC Total Hip System ( Johnson & Johnson )
ESKA Modular Hip System ( ESKA America ) ●
Vitalock Acetabular System ( Howmedica Stryker Osteonics ) ●
PCA Cluster Acetabular System ( Howmedica Stryker Osteonics ) ●

4. Description of the device :

Materials: The devices are manufactured from CoCrMo alloy, Ultra High Molecular Weight Polyethylene ( UHMWPE ), per ASTM and ISO standards.

Function: The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma.

5. Intended Use :

Comparison of the technological characteristics of the device to predicate and legally marketed devices :

There are no significant differences between the ESKA Modular Hip System Acetabular Components and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material, and intended use.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is depicted with three parallel lines forming its body and wings.

MAR 0 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ESKA Implants GmbH & Co. c/o Mr. Thomas P. Monkus, RAC Director, Regulatory Affairs and Business Development ESKA America Corporation 101 Riverfront Boulevard, Suite 600 Bradenton, Florida 34205

Re: K021878

Trade/Device Name: ESKA Modular Hip System Acetabular Components 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: December 2, 2002 Received: December 4, 2002

Dear Mr. Monkus:

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 - Mr. Thomas P. Monkus, RAC

forth in the quality systems (OS) 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) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

R. Mark A. Millersen

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 : K021878

Device Name : ESKA Modular Total Hip System Acetabular Components

Indications For Use :

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )

Concurrence of CDRH, Office of Device Evaluation ( ODE )

Prescription use ( PER 21 CFR 801.109) OR

Over-the-counter use _______

( optional format 1-2-96 )

Mark N Millmor

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

109(k) Number K021878

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.