The ComPreSs™ Distal Femoral Replacement is a metallic femoral segmental fixation stem intended to replace the distal part of the femur in cases of severe bone loss. The design of the ComPreSs™ stem allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.

AI/ML Overview

The provided documentation describes the ComPreSs™ Distal Femoral Replacement, a medical device. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Strength/Safety: Device addresses all failure mechanisms.	Non-Clinical Testing: "Testing also addressed all failure mechanisms for the device, and was found to be strong enough to begin the clinical study."
Stress Shielding: Device produces less stress shielding than standard cemented implants.	Non-Clinical Testing: "Results of mechanical testing showed that the ComPreSs™ Distal Femoral Replacement produces less stress shielding than a standard cemented implant."
Clinical Equivalence: Clinically substantially equivalent to similar knee prostheses for similar indications.	Clinical Results: "The clinical results determined that the ComPreSs™ Distal Femoral Replacement is substantially equivalent to similar knee prostheses implanted for similar indications."
Substantial Equivalence: Based on mechanical testing and clinical data, the device is substantially equivalent to the predicate device.	Summary: "Based on the results of mechanical testing and clinical data, the ComPreSs™ Distal Femoral Replacement is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document states, "Testing also addressed all failure mechanisms for the device, and was found to be strong enough to begin the clinical study." and then refers to "The clinical results determined that the ComPreSs™ Distal Femoral Replacement is substantially equivalent..."

Sample Size for Clinical Study (Test Set): The specific sample size for the clinical study is not provided in the given text.
Data Provenance: The country of origin of the data is not specified. The text only mentions "clinical results." It is likely prospective, as it refers to a "clinical study" being initiated after mechanical testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The text only mentions "clinical results" and "clinical data" without detailing how ground truth was established by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

There is no mention of an MRMC comparative effectiveness study or any effect size of human readers improving with or without AI assistance. The device in question is a physical medical implant, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

This question is not applicable as the device is a physical implant and not an algorithm.

7. The Type of Ground Truth Used

The type of ground truth used for the "clinical results" is not explicitly stated. Given it's a femoral replacement, the ground truth would likely be based on patient outcomes (e.g., pain reduction, range of motion, implant stability, absence of complications) as observed in the clinical study, compared to the outcomes of the predicate device. However, this is inferred, not explicitly stated.

8. The Sample Size for the Training Set

This information is not provided. The text refers to "clinical results" but does not distinguish between a training set and a test set for this device type. Given it's a medical implant, training sets in the context of biological data or machine learning are not typically relevant here; the "training" would be more akin to in-vitro or in-vivo testing to optimize the design, which isn't detailed with sample sizes in this summary.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is largely not applicable in the conventional sense for a physical medical implant. The design and testing would involve engineering principles and mechanical testing to establish performance parameters, rather than "ground truth" derived from patient data for a training set in the way one would for an algorithm.

Summary

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DEC 1 8 2003

K031804

page 1 of 2

BIOMET

510 (K) Summary

Applicant or Sponsor:

Biomet, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0578

Contact Person:

Gary Baker Phone: (574) 267-6639 Extension 1568

Proprietary Name: ComPreSs™ Distal Femoral Replacement.

Common Name: Segmental Femoral Stem Component.

Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer (21 CFR §888.3510)

Product Code: KRO

Device Classification: Class II

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

1. Finn Knee System Biomet Inc. (K945028)
1. Modular Replacement System -- Howmedica Inc. (K972401)

Device Description:

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

系

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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()FFFICE 574.267.6639

FAX 574.267.8137

i: MAIL liomet@hiomet.com

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K031804
page 2 of 2

Indications for Use:

The ComPreSs™ Distal Femoral Replacement System is indicated for tumors of the distal femur and revisions of oncologic distal femoral replacements.

The ComPreSs™ Distal Femoral Replacement components are intended for uncemented use.

Summary of Technologies:

The ComPreSs "M Distal Femoral Replacement is made of the same material as the predicate device. Unlike the predicate device, the ComPreSs™ Distal Femoral Replacement components are intended for uncemented use.

Non-Clinical Testing:

Results of mechanical testing showed that the ComPreSs™ Distal Femoral Replacement produces less stress shielding than a standard cemented implant. Testing also addressed all failure mechanisms for the device, and was found to be strong enough to begin the clinical study.

Clinical Results:

The clinical results determined that the ComPreSs™ Distal Femoral Replacement is substantially equivalent to similar knee prostheses implanted for similar indications.

Summary:

Based on the results of mechanical testing and clinical data, the ComPreSs™ Distal Femoral Replacement is substantially equivalent to the predicate device.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2003

Mr. Gary Baker Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K031804

Trade Name: ComPreSs" Distal Femoral Replacement Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: September 24, 2003 Received: September 25, 2003

Dear Mr. Baker:

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 Amendnents, 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. Gary Baker

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" (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,

Mark A. Milkersen

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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KO31804 510(k) Number (IF KNOWN):

Device Name: ComPreSs™ Distal Femoral Replacement

Indications for Use:

The ComPreSs™ Distal Femoral Replacement System is indicated for tumors of the distal femur and revisions of oncologic distal femoral replacements.

The ComPreSs™ Distal Femoral Replacement components are intended for uncemented use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Use ✗
(Per 21 CFR 801.109)
OR
Over-the-Counter Use __
(Optional Format 1-2-96)

vision Sign-On;
"ivision of Ganool Dententi

K031804

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.