The Global Modular Replacement System (referred to from this point on as the GMRS) Press Fit Stems with PureFix® HA Coating are intended to be used with components of the proximal femoral segment of the Howmedica Modular Replacement System (referred to from this point on as the MRS) in total hip arthroplasty. These devices are intended for use in total hip arthroplasty indicated as a result of extensive proximal femoral bone loss (from trauma, failed previous arthroplasty, or tumor resection). Adequate bone stock must be present to allow the use of the GMRS Press Fit Stems with PureFix® HA Coating.

Device Description

The GMRS Press Fit Stems with PureFix® HA Coating are machined from titanium alloy (Titanium-6Aluminum-4Vanadium) which meets the requirements of ASTM standard F-136. The stems are coated with commercially pure titanium (CP titanium) plasma spray coating that conforms to ASTM specification F-1580. The proximal portion of the stem is also coated with PureFix® HA coating which meets ASTM specification F-1185.

The proximal portion of the stem incorporates a male taper with a taper angle of 2 degrees 52 minutes. This male taper mates with the female taper portion of the head/neck section or body section of the proximal femoral section of the Modular Replacement System.

The GMRS Press Fit Stems with PureFix® HA Coating are available in four styles:

I Straight Stems: These stems are available in a 125mm length, and diameters from 11mm to 19mm in one millimeter increments. The seat diameter varies from 22 to 36mm, and the seat radius ranges from 8mm to 9.25mm.
Straight Fluted Stems: These stems are also available in a 125mm length, and diameters from 11mm to 19mm in one millimeter increments. This stem design has four flutes that extend from the seat down 25mm of the length of the stem. These flutes are located 90 degrees apart on the body of the stem. The seat diameter varies from 22mm to 36mm, and the seat radius ranges from 8mm to 9.25mm.
Curved Stem (150mm): These stems are available in a 150mm length, and diameters from 11mm to 19mm in one millimeter increments. The seat diameter of this stem ranges from 22mm to 36mm, and the seat radius ranges from 7mm to 10.5mm. The radius of the curvature is 45 inches.
Curved Stem (200mm): These stems are available in a 200mm length, and diameters from 11mm to 19mm in one millimeter increments. The seat diameter of this stem varies from 22mm to 36mm, and the seat radius ranges from 7mm to 10.5mm. The radius of the curvature is 45 inches.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for a medical device called "GMRS Press Fit Stems with PureFix® HA". This document is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It is crucial to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence, not on providing detailed clinical study results or establishing acceptance criteria in the way a clinical trial for a novel drug or a high-risk device might.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a medical device such as a hip implant is not typically found within a 510(k) summary document. These types of studies and their detailed outcomes are more characteristic of clinical trials or extensive performance testing, which might be referenced but not fully detailed in this type of summary.

The document states: "Finite element analyses and testing were present to support a claim of substantial equivalence." This indicates that some form of engineering analysis and physical testing was performed, but the specific acceptance criteria and detailed results are not elaborated upon.

Based on the provided text, here is what can and cannot be answered:

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

Cannot be provided: The document does not specify quantified acceptance criteria or detailed performance metrics from a clinical study for this hip implant. Its purpose is to demonstrate substantial equivalence to predicate devices, not to report on specific clinical performance against predetermined acceptance criteria for a novel device. The "performance" mentioned is in the context of supporting the claim of substantial equivalence through "Finite element analyses and testing," but no specific results are given.

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

Cannot be provided: The document does not describe a "test set" in the context of clinical data or a formal study with human subjects for which a sample size, provenance, or study design (retrospective/prospective) would be relevant. The "testing" mentioned refers to engineering tests and finite element analyses, not patient-based data.

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)

Cannot be provided: This information is not applicable as no clinical "test set" requiring expert ground truth establishment is described in the document.

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

Cannot be provided: This information is not applicable as no clinical "test set" requiring adjudication 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

Cannot be provided: This document relates to a hip implant (a physical device), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI-related effectiveness is irrelevant and not mentioned.

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

Cannot be provided: As this device is a physical hip implant, the concept of "standalone algorithm performance" is not applicable.

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

Cannot be provided: No specific clinical "ground truth" derived from patient data is described as part of the substantial equivalence claim. The "ground truth" in engineering analysis would relate to material properties, mechanical loads, and structural integrity, defined by engineering standards and simulations, not typically categorized as "expert consensus" or "pathology" in the medical sense.

8. The sample size for the training set

Cannot be provided: This document describes a physical medical device, not an AI algorithm that requires a "training set."

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

Cannot be provided: This is not applicable to a physical medical device.

In summary, the provided document is a 510(k) summary for a hip implant. Its purpose is to demonstrate substantial equivalence to existing devices through a description of components and manufacturing, along with mentioning supporting engineering analyses and testing. It does not contain the detailed clinical study design, performance metrics, sample sizes, or ground truth establishment methods typically associated with clinical trials or AI performance evaluations.

Summary

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GMRS Press Fit Stems with PureFix® HA Confidential

510(k) Premarket Notification

OCT 1 7 2002

page 1 of 3

510(k) Summary

Submission Information

Name and Address of Sponsor:

Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401

For Information contact:

Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401

Device Identification

GMRS Press Fit Stems with PureFix® HA Proprietary Name: Modular Stem Common Name: Classification Name and Reference 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Class II Proposed Regulatory Class: Device Product Code: OR(87) LZO

Intended Use

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GMRS Press Fit Stems with PureFix® HA Confidential

Indications

Proximal femoral reconstruction secondary to:

Trauma
Failed previous prosthesis .
Tumor resection .

Contraindications

Overt infection .
Rapid disease progression beyond an acceptable margin .

For the use of GMRS Press Fit stems with PureFix® HA Coating, the following additional contraindication should be noted:

. Inadequate bone stock to allow the use of a press fit stem

Device Description

The GMRS Press Fit Stems with PureFix® HA Coating are available in four styles:

I Straight Stems: These stems are available in a 125mm length, and diameters from 11mm to 19mm in one millimeter increments. The seat diameter varies from 22 to 36mm, and the seat radius ranges from 8mm to 9.25mm.
510(k) Premarket Notification

page 2 of 3

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GMRS Press Fit Stems with PureFix® HA Confidential

Straight Fluted Stems: These stems are also available in a 125mm length, and 피 diameters from 11mm to 19mm in one millimeter increments. This stem design has four flutes that extend from the seat down 25mm of the length of the stem. These flutes are located 90 degrees apart on the body of the stem. The seat diameter varies from 22mm to 36mm, and the seat radius ranges from 8mm to 9.25mm.
510(k) Premarket N
Curved Stem (150mm): These stems are available in a 150mm length, and diameters I from 11mm to 19mm in one millimeter increments. The seat diameter of this stem ranges from 22mm to 36mm, and the seat radius ranges from 7mm to 10.5mm. The radius of the curvature is 45 inches.
Curved Stem (200mm): These stems are available in a 200mm length, and diameters . from 11mm to 19mm in one millimeter increments. The seat diameter of this stem varies from 22mm to 36mm, and the seat radius ranges from 7mm to 10.5mm. The radius of the curvature is 45 inches.

Equivalent products include:

MRS Cemented Stems Howmedica Osteonics 1.
Distal Stem Segments of the Restoration Modular Femoral Stem Howmedica 2. Osteonics

Finite element analyses and testing were present to support a claim of substantial equivalence.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

OCT 1 7 2002

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401

Received: July 23, 2002

Re: K022403

Trade/Device Name: GMRS Press Fit Stems with PureFix® HA Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint/metal/ceramic/polymer/semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Codes: LZO Dated: July 22, 2002

Dear Ms. Crowe:

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

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Page 2 - Ms. Margaret F. Crowe

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, 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). 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 vours.

Mark A. 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 lofl

510(k) Premarket Notification

GMRS Press Fit Stems with PureFix® HA Confidential

510(k) Number (if known): KOL2403

Device Name: GMRS Press Fit Stems with PureFix® HA

Intended Use

The Global Modular Replacement System (referred to from this point on as the GMRS) Press Fit Stems with PureFix® HA Coating are intended to be used with components of the proximal femoral segment of the Howmedica Modular Replacement System in total hip arthroplasty. These devices are intended for use in total hip arthroplasty indicated as a result of extensive proximal femoral bone loss (from trauma, failed previous arthroplasty, or tumor resection). Adequate bone stock must be present to allow the use of the GMRS Press Fit Stems with PureFix® HA Coating.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-the Counter-Use

801.109)

Mark N Millman

Restorative 2403 510(k) Number

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.