The ESKA-LIBUR Hip Stem is indicated for use in the treatment rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, vascular necrosis, non-union of femoral neck fractures, fracture dislocation of the hip, conversion of unsuccessful arthodeses and revision of previous hip surgeries.

Device Description

The ESRA LILOR The stem is available in thirteen sizes with a distal M/L dimension ranging alle 150 5645-4. The Stein 120mm to 180mm. It is modular in nature such that a from 7mm to 19.5mm, and lengals xosal body accepts an adaptor that has male tapers on both ends. One end engages the hip stem and the other a modular head. The distal end of the stem is color buffed while proximal body has the same Spongiosa Metal II® Surface cast into same as the predicate ESKA Modular Hip Stem.

AI/ML Overview

This document is a 510(k) summary for the ESKA-LIBUR Hip Stem. It describes the device, its intended use, and provides a summary of nonclinical tests. Based on the provided text, the following information can be extracted:

A table of acceptance criteria and the reported device performance

Acceptance Criteria Reported Device Performance
ISO 7206-4 "The ESKA-LIBUR Hip Stem was tested according to ISO 7206-4."

Note: The document confirms testing was done to the specified standard but does not provide specific performance data or numerical results from this testing in this section.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document describes nonclinical testing, which typically refers to laboratory or bench testing rather than clinical data from human subjects. Therefore, information regarding human test sets, sample sizes for those sets, or data provenance (country, retrospective/prospective) is not applicable or not provided in this 510(k) summary for clinical performance. The "test set" in this context refers to the physical hip stem devices subjected to mechanical testing. The sample size for these mechanical tests is not specified.
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)

This information is not applicable as the document describes nonclinical, mechanical testing of a medical device, not a diagnostic or AI-driven decision-making system. "Ground truth" in this context primarily relates to the physical and mechanical properties of the device as measured against the ISO standard.
Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as point 3. Mechanical testing does not involve adjudication by experts in the way clinical studies or AI performance evaluations do.
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

This information is not applicable. This document is a 510(k) summary for a hip stem, a medical implant. It does not involve AI or human readers for diagnostic interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the nonclinical test was the ISO 7206-4 standard for hip joint prostheses. Compliance with this standard indicates the device's mechanical integrity and performance under specified conditions.
The sample size for the training set

This information is not applicable. This document describes the testing of a physical medical device. There is no "training set" in the context of an AI/ML algorithm.
How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

Acceptance Criteria	Reported Device Performance
ISO 7206-4	"The ESKA-LIBUR Hip Stem was tested according to ISO 7206-4."

Summary

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ESKA-LIBUR Hip Stem 510(k) Summary

K053557 page 1 of

Date	December 19, 2005
Submitter	ESKA Implants GmbH & Co.
	JAN 20 2006
Contact person	J.D. Webb
	1001 Oakwood Blvd
	Round Rock, TX 78681
	512-388-0199
Trade Name	ESKA-LIBUR Hip Stem
Common name	Press-fit hip
Classification name	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
	Class II per 21 CFR section 888.3358
Product Code	LPH
Equivalent Device	The ESKA-LIBUR Hip Stem is a modification to the ESKA Modular Hip
	System (K993027). It has the same indications, similar geometry, the
	same material and the same Spongiosa Metal II® Surface.
	The ESKA-LIBUR hip is also similar in modular neck design as the R120
	Total Hip (Osteoimplant Technology, Inc. K0117774/K021822) and the
	Profemur Hip (Wright Technology K041586).

Device Description

Device Description The ESRA LILOR The stem is available in thirteen sizes with a distal M/L dimension ranging alle 150 5645-4. The Stein 120mm to 180mm. It is modular in nature such that a from 7mm to 19.5mm, and lengals xosal body accepts an adaptor that has male tapers on both ends. One end engages the hip stem and the other a modular head.

The distal end of the stem is color buffed while proximal body has the same Spongiosa Metal II® Surface cast into same as the predicate ESKA Modular Hip Stem.

Intended Use

The ESKA-LIBUR Hip Stem is indicated for use in the treatment rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, vascular necrosis, non-union of femoral neck fractures, ostcoatinitis, post traintate artifies, vasual of unsuccessful arthodeses and revision of previous hip surgeries.

Summary Nonclinical Tests

The ESKA-LIBUR Hip Stem was tested according to ISO 7206-4.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 2006

ESKA Implants GmbH & Co c/o Mr. J. D. Webb Orthomedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681

K053557 Re:

Trade/Device Name: ESKA LIBUR Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, JDI Dated: December 19, 2005 Received: December 21, 2005

Dear Mr. Webb:

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

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Page 2 - Mr. J. D. Webb

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.

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Acting 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

Kos-357

510(k) Number (if known):

Device Name: ESKA-LIBUR Hip Stem

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use
(21 CFR 807 Subpart C) No

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number ﮐ ﮐ 5 5 ﮐ

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.