MALLORY/HEAD SMOOTH FEMORAL COMPONENT by BIOMET, INC.

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Revision procedures where other treatment or devices have failed
Treatment of nonunions, which are femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
This device is for use with bone cement.

Device Description

The Mallory/Head Smooth femoral components are composed of Co-Cr-Mo alloy conforming to ASTM F-799 standards. The Mallory/Head Smooth is to be used with bone cement. A progressive increase in cross-sectional dimensions and overall length is seen throughout the range of sizes (size 1 -- 5). The straight stem design eliminates the need for left and right configurations.
The most defining feature of this series is the surface geometry and finish of the stem body. The finish is sisal buff in one direction (proximal to distal) around the entire stem with a roughness (Ra) value not less than 24 microinches. The surface is void of ledges, grooves, and collars. This smooth design will allow minute amounts of subsidence over an extended period of time. The smooth stem is used with the centralizer/sinker set so that the stem continues to remain tightly wedged in place rather than loosening progressively over time.
The centralizer/sinker set consists of two polymethylmethacrylate (PMMA) pieces. The sinker fits on the distal tip of the stem and creates a 2-3 mm (in length) void in the cement mantle. Without this void, distal to the tip of the stem, small amounts of subsidence would cause undesirable point loads in the cement. The centralizer is designed to fit on the central one-third of the stem and to provide a cement mantle of uniform thickness around the stem.
The Mallory/Head Smooth Femoral Component can be used with any Biomet modular head with a Type 1 taper, such as: Cobalt Chrome modular heads, Zirconia modular heads or an endoprosthesis head. Zirconia ceramic heads have been previously cleared in 510(k)'s: K905687, K913420, K925345, K943586. K964431. K991708. For metallic heads the surface of the bore of the head was measured to have a roughness (Rg) value of 34 microinches. The articulating surface roughness (Ra) value was found to be 5.6. The ceramic heads have a surface roughness of Rg < 0.2 microns on the articulating surface and 0.4 - 0.8 microns in the head bore. Any commercially available acetabular component may be used with the Mallory/ Head Smooth femoral component.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Mallory/Head Smooth Femoral Stem, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with predefined acceptance criteria.

Therefore, the document does not contain information about acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as typically sought for AI/diagnostic devices.

The submission is for a hip femoral component prosthesis, which is a physical implant, not a diagnostic or AI-driven device. As such, the FDA's clearance is based on a review of the device's design, materials, and intended use, and its substantial equivalence to previously cleared predicate devices.

Here's what can be extracted from the text in relation to your request, with the understanding that it won't fulfill all aspects due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" such as sensitivity, specificity, or accuracy are provided, nor is there a performance study reporting these metrics. The performance is assessed through demonstration of "substantial equivalence" to predicate devices, focusing on design, materials, and intended use.

Acceptance Criteria (Implied by 510(k) Process)	Reported Device Performance
Material Composition: Conformance to established standards.	Co-Cr-Mo alloy conforming to ASTM F-799 standards.
Surface Geometry/Finish: Adherence to defined characteristics.	Sisal buff finish in one direction (proximal to distal) around the entire stem with a roughness (Ra) value not less than 24 microinches. Surface is void of ledges, grooves, and collars.
Compatibility with other components:	Can be used with any Biomet modular head with a Type 1 taper (Cobalt Chrome, Zirconia, endoprosthesis). Compatible with any commercially available acetabular component.
Roughness of modular heads: Adherence to specified values.	For metallic heads: surface of the bore Ra value of 34 microinches, articulating surface Ra value of 5.6. For ceramic heads: articulating surface Ra < 0.2 microns, head bore 0.4 - 0.8 microns.
Functional Design: E.g., progressive increase in cross-sectional dimensions, straight stem, use with centralizer/sinker set.	Progressive increase in cross-sectional dimensions and overall length (size 1-5). Straight stem design eliminating need for left/right. Used with centralizer/sinker set to ensure tight wedging and prevent point loads from subsidence.
Safety: Identification of potential risks.	Potential risks are the same as any other joint replacement device, including fracture of component, loosening, infection, etc. (These are identified but not quantified in terms of acceptance metrics in this document).
Substantial Equivalence: Similarity to legally marketed predicate devices.	Direct comparison made with Biomet Cobalt-Chrome Femoral Component (K911684), Rx 90 Hip System (K942028), and Color Buffed Cemented Femoral (K992903).

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

Sample Size: Not applicable/Not provided. The 510(k) submission describes the device characteristics and compares them to predicate devices. It does not involve a "test set" in the context of clinical performance evaluation for diagnostic devices.
Data Provenance: Not applicable. The information provided is design and material specification data, along with a list of predicate devices.

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

Not applicable. "Ground truth" in the context of expert consensus is not relevant to this type of device submission. The FDA reviews the technical documentation and comparison to predicates.

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

Not applicable. There is no test set in the diagnostic sense, and therefore no adjudication method.

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 is not an AI-assisted diagnostic device, so MRMC studies are irrelevant.

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

Not applicable. This is a physical implant, not an algorithm.

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

Not applicable. The "ground truth" for this device's clearance is its adherence to material standards, design specifications, and successful demonstration of substantial equivalence to existing, legally marketed predicate devices, which implies a history of safe and effective use.

8. The sample size for the training set:

Not applicable. This is not an AI device, so there is no training set.

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

Not applicable.

Summary

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FEB 1 2000

SUMMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR: Biomet, Inc. Airport Industrial Park P. O. Box 587 Warsaw IN 46580 -0587

CONTACT PERSON: Tina Lakin (219) 267-6639 ext. 1816

DEVICE NAME: Mallory/ Head Smooth Femoral Stem

CLASSIFACTION NAME: Hip Femoral Component Prosthesis, Cemented, Metal (CFR 888.3360)

INDICATIONS FOR USE: Mallory/ Head Smooth femoral stem is indicated for use in:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
1. Rheumatoid arthritis
1. Correction of functional deformity
1. Revision procedures where other treatment or devices have failed
1. Treatment of nonunions, which are femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

DEVICE DESCRIPTION: The Mallory/Head Smooth femoral components are composed of Co-Cr-Mo alloy conforming to ASTM F-799 standards. The Mallory/Head Smooth is to be used with bone cement. A progressive increase in cross-sectional dimensions and overall length is seen throughout the range of sizes (size 1 -- 5). The straight stem design eliminates the need for left and right configurations.

The most defining feature of this series is the surface geometry and finish of the stem body. The finish is sisal buff in one direction (proximal to distal) around the entire stem with a roughness (Ra) value not less than 24 microinches. The surface is void of ledges, grooves, and collars. This smooth design will allow minute amounts of subsidence over an extended period of time. The smooth stem is used with the centralizer/sinker set so that the stem continues to remain tightly wedged in place rather than loosening progressively over time.

The centralizer/sinker set consists of two polymethylmethacrylate (PMMA) pieces. The sinker fits on the distal tip of the stem and creates a 2-3 mm (in length) void in the cement mantle. Without this void, distal to the tip of the stem,

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small amounts of subsidence would cause undesirable point loads in the cement. The centralizer is designed to fit on the central one-third of the stem and to provide a cement mantle of uniform thickness around the stem.

The Mallory/Head Smooth Femoral Component can be used with any Biomet modular head with a Type 1 taper, such as: Cobalt Chrome modular heads, Zirconia modular heads or an endoprosthesis head. Zirconia ceramic heads have been previously cleared in 510(k)'s: K905687, K913420, K925345, K943586. K964431. K991708. For metallic heads the surface of the bore of the head was measured to have a roughness (Rg) value of 34 microinches. The articulating surface roughness (Ra) value was found to be 5.6. The ceramic heads have a surface roughness of Rg < 0.2 microns on the articulating surface and 0.4 - 0.8 microns in the head bore. Any commercially available acetabular component may be used with the Mallory/ Head Smooth femoral component.

POTENTIAL RISKS: The potential risks with this device are the same with any other joint replacement device. These include, but are not limited to:

Fracture of component Cardiovascular disorders Implant loosening/migration Soft tissue loosening Deformity of the joint Tissue growth failure Delayed wound healing Metal sensitivity
Bone fracture Hematoma Blood vessel damaqe Nerve damage Excessive wear Infection Dislocation

SUBSTANTIAL EQUIVALENCE: The Mallory/Head Smooth femoral component is similar to most femoral components on the market today in terms of overall intended function and design. Direct comparison was made with the following predicates:

Biomet Cobalt-Chrome Femoral Component (Mallory/Head Cemented . Femoral) - (Biomet Inc. - 510(k) K911684)
Rx 90 Hip System - (Biomet Inc. - 510(k) K942028)
Color Buffed Cemented Femoral (Biomet Inc. 510(k) K992903) .

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Public Health Service

FEB 4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tina Lakin Regulatory Specialist Biomet, Inc. P.O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587

Re: K994007 Trade Name: Mallory/Head Smooth Femoral Stem Regulatory Class: II Product Code: JDI Dated: November 23, 1999 Received: November 24, 1999

Dear Ms. Lakin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a

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Page 2 - Ms. Tina Lakin

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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil R.P. Ogden

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _/ of _/

510(k) NUMBER (IF KNOWN): K994007

DEVICE NAME: Mallory/ Head Smooth femoral component

INDICATIONS FOR USE:

The Mallory/ Head Smooth femoral component is indicated for:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
1. Rheumatoid arthritis
1. Correction of functional deformity
1. Revision procedures where other treatment or devices have failed
1. Treatment of nonunions, which are femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

This device is for use with bone cement.

NRO for SED
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K994007

(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)

Over-The-Counter-Use No
(Optional Format 1-2-96)

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Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.