The indications for use for Biomet hip replacement prosthesis include: 1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) treatment of non-union, femoral neck fracture, and throchanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) revisions of hip replacement components. Standard surgical and rehabilitative procedures are indicted with this device. This device is for use with bone cement.

Device Description

The Color Buffed Cemented Femorals are designed to replace a diseased or damaged femoral neck. A modular head attaches to trunion to complete the femoral side of a total hip. The stems are indicated for cement use and are distally tapered to provide better stress distribution through the cement mantle. A reduced superior lateral insures easier insertion while maintaining proximal canal filling. A reduced medial collar provides greater range of motion, stability, and prevention of component subsidence. Each stem is straight, thus eliminating the need for a left and right configurations. The stems utilize a modular head to provide an articulating surface with any commercially available acetabular component. These components are intended for use with bone cement, and as such. have PMMA spacers added to the stem to enhance stability within the cement mantle.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device and does not contain the requested information regarding acceptance criteria, study details, or performance metrics.

The provided text is a regulatory approval letter and device description for the "Color Buffed Cemented Femoral," a hip replacement component. It discusses the device's design, indications for use, potential risks, and its substantial equivalence to previously marketed devices.

To answer your request, a detailed performance study report would be required, which is typically a separate document and not included in this regulatory communication.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample size used for the test set and the data provenance: Not available.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
Adjudication method for the test set: Not applicable.
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 a medical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document is purely a regulatory approval for marketing based on substantial equivalence, not a detailed performance study.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor: Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587

Contact: Dalene Hufziger Binkley (219) 372-1612

Trade Name: Color Buffed Cemented Femoral

Classification Name: Hip joint metal/polymer semi-constrained cemented prosthesis (CFR 888.3350).

Device Description: The Color Buffed Cemented Femorals are designed to replace a diseased or damaged femoral neck. A modular head attaches to trunion to complete the femoral side of a total hip. The stems are indicated for cement use and are distally tapered to provide better stress distribution through the cement mantle. A reduced superior lateral insures easier insertion while maintaining proximal canal filling. A reduced medial collar provides greater range of motion, stability, and prevention of component subsidence. Each stem is straight, thus eliminating the need for a left and right configurations. The stems utilize a modular head to provide an articulating surface with any commercially available acetabular component. These components are intended for use with bone cement, and as such. have PMMA spacers added to the stem to enhance stability within the cement mantle.

Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but not limited to:

Reaction to bone cement Deformity of the joint Cardiovascular diseases Fracture of the cement Implant loosening/Migration Tissue growth failure

Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Nerve damage

Bone fracture Infection Hematoma Dislocation Excessive wear

K992963

Modifications were made to the Answer Femoral Component to produce the Color Buffed Cemented Femoral.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three people, one behind the other, with their arms raised. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1999

Ms. Dalene Hufziger Binkley Biomet, Inc. P.O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587

Re: K992903 Trade Name: Color Buffed Cemented Femoral Regulatory Class: II Product Code: JDI Dated: August 19, 1999 Received: August 30, 1999

Dear Ms. Hufziger Binkley:

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.

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Page 2-Ms. Dalene Hufziger Binkley

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 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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) NUMBER (IF KNOWN): __

DEVICE NAME: Color Buffed Cemented Femoral

INDICATIONS FOR USE:

Standard surgical and rehabilitative procedures are indicted with this device.

This device is for use with bone cement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	Over-The-Counter-Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

(Division Sigr. Off,
Div eral Restorative Devices
510(k) Number	K992903	000005

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.