K Number

Device Name

Manufacturer

SMITH & NEPHEW, INC.

Date Cleared

2003-02-26

(61 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Oxinium Femoral Heads are for single use only and can be used as part of cemented or uncemented total hip arthroplasty.

Device Description

The Oxinium Femoral Heads are designed for use with femoral stems and acetabular components distributed by Smith & Nephew. The Oxinium Femoral Heads are metal alloy devices processed via a proprietary oxidation process.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Oxinium Femoral Heads). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical efficacy trial with detailed acceptance criteria and a study design to meet those criteria in the way an AI/ML device might.

Therefore, the information requested in the prompt (acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission and the data presented.

Instead, the document focuses on:

Mechanical and Clinical Data: A general statement about mechanical equivalence to currently used devices and ability to withstand in vivo loading without failure. Details of specific acceptance criteria for these mechanical tests are not provided.
Wear Claims: These are marketing claims based on in vitro simulator testing. The document explicitly states: "The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance." This means these in vitro results are not presented as meeting clinical acceptance criteria in the manner of a human study.
Substantial Equivalence Information: The core of the 510(k) submission, confirming the device's similarities to existing predicate devices in design, indications, and material composition.

However, I can extract the closest information available, framed as "reported device performance" and the "study" that generated these figures, which are the in vitro wear tests:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by wear claims)	Reported Device Performance (from in vitro wear tests)
N/A (No explicit acceptance criteria for in vitro wear rates provided in the document for regulatory approval, these are marketing claims.)	Oxinium Femoral Heads vs. CoCr with conventional polyethylene:
	- 45% reduction in volumetric wear rates against conventional polyethylene (compared to equivalent sized CoCr femoral heads).
	- 61% reduction in volumetric wear rates against conventional polyethylene under roughened conditions (compared to equivalent sized CoCr femoral heads).
	Oxinium Femoral Heads vs. CoCr with crosslinked polyethylene:
	- Show no detectable wear when used with crosslinked polyethylene.
	- CoCr Femoral Heads show 15 times more volumetric wear against crosslinked polyethylene as compared to Oxinium Femoral Heads under roughened conditions.
	- Oxinium Femoral Heads on crosslinked polyethylene show no detectable wear in traditional or roughened conditions (CoCr head shows measurable increase in wear rate of crosslinked liners when roughened).

2. Sample size used for the test set and the data provenance

Sample Size: "Five million cycles per individual test." (This refers to cycles of mechanical testing, not a patient or human-subject sample size). The number of individual tests (e.g., how many Oxinium/CoCr heads were tested) is not specified, but the phrasing "per individual test" implies multiple tests were conducted to generate the results.
Data Provenance: In vitro laboratory testing using "a multi-axial hip joint simulator," "Reflection Acetabular Liner," and "Hyclone Modified Alpha Serum lubricant." This is laboratory data, not human patient data, and therefore has no country of origin in the clinical sense. It is by definition "retrospective" as the data would have been collected prior to submission.

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

Not applicable. The "ground truth" for wear rates was established by mechanical measurements (weight loss of polyethylene liner converted to volume loss) and linear regression analysis, not by human expert assessment.

4. Adjudication method for the test set

Not applicable. No human adjudication was involved in measuring the in vitro wear rates.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is for evaluating human performance, typically in diagnostic imaging, which is not relevant to a mechanical orthopedic implant.

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

Not applicable. This concept pertains to AI/ML algorithms. The device is a physical orthopedic implant. The "performance" described is purely mechanical/material.

7. The type of ground truth used

Mechanical Measurement: Wear was determined by weight loss of the polyethylene liner, which was then divided by the density of the polyethylene to determine volume loss. Least squares linear regression of volume loss versus cycle count was used to determine volumetric wear rates. This is a physical, objective measurement from the in vitro test.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling from a dataset. The in vitro tests are essentially a test set to characterize the material performance.

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

Not applicable, as there is no "training set."

Summary of the K024340 Submission Approach:

The K024340 submission for Oxinium Femoral Heads relies on demonstrating substantial equivalence to existing legally marketed predicate devices primarily through:

Similarities in design features, overall indications, and material composition.
In vitro mechanical testing to demonstrate the device's ability to withstand expected in vivo loading (though specific acceptance criteria for this are not detailed in the provided text).
In vitro wear performance claims, which are explicitly stated not to correlate with clinical wear mechanisms or performance, but rather serve as marketing claims based on laboratory data.

This is a typical approach for a 510(k) for a Class II orthopedic device, where extensive clinical trials with human subjects and associated specific acceptance criteria for efficacy (as would be seen for a PMA or an AI/ML device) are generally not required if substantial equivalence can be demonstrated.

Summary

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FEB 2 6 2003

Summary of Safety and Effectiveness Smith & Nephew, Inc. Oxinium Femoral Heads (K024340)

Page 1 of 3

Contact Person and Address

Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566

Device Description

Device Classification Name

21 CFR 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis:Class II 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis - Class II

21 CFR 888.3358 Hip joint metal/ polymer/metal semi-constrained porous coated uncemented prosthesis - Class II

Indications for Use

Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Oxinium Femoral Heads are for single use only and can be used as part of cemented or uncemented total hip arthroplasty.

Mechanical and Clinical Data

A review of the mechanical test data indicated that the Oxinium Femoral Heads are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.

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Wear Claims

The following marketing claims will be made for the Oxinium Femoral Heads:

Oxinium Femoral Heads show a 45% reduction in volumetric wear rates [1] 1) against conventional polyethylene when compared to equivalent sized CoCr femoral heads. Testing was performed in a multi-axial hip joint simulator for five million cvcles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Acetabular Liner (32mm I.D., 54mm O.D., 11mm thickness, 20° overhang), and Hyclone Modified Alpha Serum lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.
Oxinium Femoral Heads show a 61% reduction in volumetric wear rates [1] 2) against conventional polyethylene under roughened [2] conditions as compared to equivalent sized CoCr femoral heads. Testing was performed in a multi-axial hip ioint simulator for five million cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Acetabular Liner (32mm I.D., 54mm O.D., 11mm thickness, 20° overhang); and Hyclone Modified Alpha Serum lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.
- 3) Oxinium Femoral Heads and CoCr Femoral Heads show no detectable wear [1] when used with crosslinked polyethylene. Testing was performed in a multi-axial hip joint simulator for five millions cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Crosslinked (10Mrad) Acetabular Liner (32mm I.D., 54-56mm O.D., 11mm thickness, Size "F", 20° overhang); and Hyclone Modified Alpha Serum lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.
- 1. CoCr Femoral Heads show 15 times more volumetric wear []] against crosslinked polyethylene as compared to Oxinium Femoral Heads under roughened conditions [2]. Testing was performed in a multi-axial hip joint simulator for five millions cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Crosslinked (10Mrad) Acetabular Liner (32mm I.D., 54-56mm O.D., 11mm thickness, Size "F", 20° overhang); and Hyclone Modified Alpha Serum lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.

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K024340
Page 3 of 3

1. Oxinium Femoral Heads on crosslinked polyethylene show no detectable wear in traditional or roughened [2] conditions. Conversely, there is a measurable increase in the wear rate of crosslinked liners when a CoCr head is roughened. Testing was performed in a multi-axial hip joint simulator for five millions cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Crosslinked (10Mrad) Acetabular Liner (32mm I.D., 54-56mm O.D., 11mm thickness, Size "F", 20° overhang); and Hyclone Modified Alpha Serum lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.
  [1] Wear was determined by weight loss of the polyethylene liner, which was then divided by the density of the polyethylene to determine volume loss. Least squares linear regression of volume loss versus cycle count was used to determine volumetric wear-rates.

[2] The roughened condition test is conducted in an effort to evaluate the effects of third body wear on the wear performance of total joint devices. The femoral heads are tumbled with abrasive media prior to testing. This method has been found to simulate the scratch patterns seen on clinically retrieved femoral heads.

Substantial Equivalence Information

The substantial equivalence of the Oxinium Femoral Heads is substantiated by its similarities in design features, overall indications, and material composition as existing femoral head components distributed by Smith & Nephew, Inc.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings and two wavy lines below representing its body.

Public Health Service

FEB 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kim P. Kelly Senior Regulatory & Clinical Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116

Re: K024340 Trade/Device Name: Oxinium Femoral Heads Regulation Number: 21 CFR 888.3350, 888.3353, 888.3358 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI, LZO, LPH Dated: January 24, 2003 Received: January 27, 2003

Dear Ms. Kelly:

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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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) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,

sincerely yours,

Mark N Milkerson

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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Page 1 of 1

K024340 Oxinium Femoral Heads Indications Statement

for Mark N. Milkerem

Division Sign-Off) Division of General. Restorative and Neurological Devices

(0) 4340 510(k) Number_

Concurrence of CDRH, Office of Device Evaluation

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR (Per 21 CFR 801.109) Over-The Counter Use

Regulation Number and Section

N/A