Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
Revision of previously failed total hip arthroplasty.

Device Description

The Medallion Modular Hip System is a complete system of femoral stem implants. The implants have a proximal female dovetail groove attachment site that is utilized for attaching various modular trunnions. The modular trunnions have a distal male semi-dovetail projection that engages the female dovetail groove on one side in such a way that a keyway is defined between the two components. The implants also include a key that is to be wedged in the keyway to lock the three components together and prevent relative sliding.

AI/ML Overview

The provided text is a 510(k) summary for the Medallion Modular Hip System. This document describes a medical device, and the information requested pertains to the acceptance criteria and detailed study information typically found for diagnostic devices or AI/ML-driven devices.

Based on the provided text, the Medallion Modular Hip System is an orthopedic implant (a total hip femoral component). For such devices, "acceptance criteria" usually refer to mechanical performance standards (e.g., strength, fatigue life, wear resistance) rather than diagnostic accuracy metrics.

Therefore, many of the requested categories are not applicable to this type of device and the information is not present in the provided 510(k) summary. I will answer what can be gleaned from the text.

Acceptance Criteria and Reported Device Performance

For an orthopedic implant like the Medallion Modular Hip System, acceptance criteria are typically related to mechanical strength and durability. The document states:

Acceptance Criteria (Implied)	Reported Device Performance
Sufficient strength for intended use	"Testing demonstrates that the design has sufficient strength for the intended use"
Not present additional safety or efficacy issues compared to predicates	"The differences between the Medallion Modular Hip System and the predicates are not significant and have shown not to present additional safety or efficacy issues."
Substantial equivalence to predicate devices	"The information presented demonstrates that the Medallion Modular Hip System is substantially equivalent to currently marketed predicate devices."

Study Details (Based on provided text)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any specific test set.
- Data Provenance: Not specified. It is implied that typical non-clinical bench testing was performed, likely in a laboratory setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. Ground truth in the context of diagnostic accuracy for expert consensus is not relevant for an orthopedic implant's mechanical testing.
Adjudication method for the test set:
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used for reconciling expert opinions in diagnostic studies, which is not relevant here.
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:
- No. This is not an AI/ML-driven diagnostic device. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-driven device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For mechanical testing, the "ground truth" would be the measured mechanical properties of the device components compared to engineering specifications and performance of predicate devices.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of AI/ML or diagnostic models.
How the ground truth for the training set was established:
- Not applicable.

Summary of what the document explicitly states regarding studies:

Non-Clinical Testing: "The information presented demonstrates that the Medallion Modular Hip System is substantially equivalent to currently marketed predicate devices. The differences between the Medallion Modular Hip System and the predicates are not significant and have shown not to present additional safety or efficacy issues." This implies mechanical bench testing was performed.
Clinical Testing: "No clinical testing was conducted for this design." This is a key statement, indicating that the device's substantial equivalence was based solely on non-clinical data and comparison to predicate devices.

Summary

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DEC 2 1 2004

K041850 (pg 1 of 2)

510(k) Summary

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Lonnie Witham

Proprietary Name: Medallion Modular Hip System

Common Name: Total hip femoral component

Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous, uncemented (888.3558)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Modular Hip Stem (Apex Surgical, LLC; K000788) .
PRO-FEMUR Hip System (Wright Medical Technology, Inc; K012091, . K003016)
Reach Femoral Component (Biomet, Inc; K000760) .

Device Description:

Intended Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
1. Rheumatoid arthritis
1. Correction of functional deformity
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
1. Revision of previously failed total hip arthroplasty.

Summary of Technologies: The Medallion Modular Hip System has the same indications for use, intended use, and materials as the predicate devices. Testing demonstrates that the design has sufficient strength for the intended use,

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K041850 (pg 2 of 2.)

Non-Clinical Testing:

The information presented demonstrates that the Medallion Modular Hip System is substantially equivalent to currently marketed predicate devices. The differences between the Medallion Modular Hip System and the predicates are not significant and have shown not to present additional safety or efficacy issues.

Clinical Testing: No clinical testing was conducted for this design.

All trademarks are property of Biomet, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 21 2004

Mr. Lonnie Witham Senior Regulatory Specialist Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K041850

Trade Name: Medallion Modular Hip System 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: July 7, 2004

Received: July 8, 2004

Dear Mr. Witham:

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 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.

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Page 2 - Mr. Lonnie Witham

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/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.

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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14041850

Indications for Use

510(k) Number (if known):

Device Name: Medallion Modular Hip System

Indications For Use:

Non-inflammatory degenerative joint disease including osteoarthritis and i 1) avascular necrosis
Rheumatoid arthritis 2)
Correction of functional deformity 3)
Oomeolion of fanotional femoral neck fracture, and trochanteric 4) Treathent of the proximal femur with head involvement, unmanageable using other techniques
acing other to treviously failed total hip arthroplasty. 5)

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

rence of CDRH, Office of Device Evaluation (ODE) Division of Gener

and Neurological Devic

Page 1 of 1

510(k) Number L041650

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.