The Columbus Total Knee System (CR) is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

The Columbus Knee (CR) is designed for use with bone cement.

Device Description

The cemented Columbus Knee System (CR) is available with one femoral design, the Cruciate Retaining (CR) which retains the ligament (PCL) during implantation. The design of the femoral component, and tibial plateau (tray) are manufactured from CoCrMo. The tibial "gliding surfaces" (inserts) and patellas are manufactured from UHMWPE.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Columbus Total Knee System (CR)", a medical device. The information provided is for regulatory clearance based on substantial equivalence, not a detailed clinical study demonstrating device performance against specific acceptance criteria. Therefore, most of the requested information about device acceptance criteria and a study proving it cannot be extracted from this document.

Here's an analysis of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no explicit table of acceptance criteria or reported device performance against such criteria. The document states:

Acceptance Criteria	Reported Device Performance
Not specified as discrete, measurable criteria for the Columbus Total Knee System (CR).	Biomechanical testing results demonstrate the Columbus Knee System is substantially equivalent to other knee systems currently on the market.

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

Sample Size (Test Set): Not applicable. This document does not describe a clinical study with a test set of patients. It refers to "Biomechanical testing results," which typically involve laboratory tests on the device itself, not human subjects.
Data Provenance: Not applicable.

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

Not applicable. There is no mention of experts establishing ground truth for a test set in the context of this 510(k) submission.

4. Adjudication method for the test set:

Not applicable.

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. The Columbus Total Knee System is a mechanical implant; it does not involve AI or human "readers" in the context of a diagnostic or assistive technology.

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

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

7. The type of ground truth used:

Not applicable in the sense of a clinical study with a "ground truth" derived from patient outcomes. The "ground truth" here is implied by the "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses," which outlines the required biomechanical tests and standards for demonstrating safety and effectiveness. The "ground truth" is adherence to these established engineering and mechanical performance parameters, and comparison to predicate devices.

8. The sample size for the training set:

Not applicable. This document does not describe the development or testing of an AI model, so there is no training set mentioned.

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

Not applicable.

Summary of Relevant Information from the Document:

The Columbus Total Knee System (CR) received 510(k) clearance by demonstrating "substantial equivalence" to legally marketed predicate devices. This equivalence was supported by:

Biomechanical testing: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses' were completed. Biomechanical testing results demonstrate the Columbus Knee System is substantially equivalent to other knee systems currently on the market."
Predicate Devices:
- Search Evolution Total Knee System (K021313)
- Scorpio Posterior Cruciate Retaining Knee System (K974556)
- Gem Knee System (K994214)

In essence, the "acceptance criteria" for this device's regulatory clearance were met by fulfilling the requirements of the FDA's guidance document for knee prostheses and proving its performance via biomechanical testing was comparable to existing, legally marketed devices. The study proving this involves the aforementioned biomechanical tests, but the document does not provide details on their methodology, sample sizes (e.g., number of test specimens), or specific quantitative results beyond the statement of substantial equivalence.

Summary

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Columbus Total Knee System

8 2002 NOV

02267d

Page 1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS c. [in Accordance with SMDA of 1990]

Columbus Total Knee System (CR)

April 1, 2001

Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034

Establishment Registration Number: 2916714

Joyce Kilroy CONTACT: 800/258-1946 x 5074 (phone) 610/791-6882 (fax)
TRADE NAME: Columbus (CR)
COMMON NAME: Columbus Total Knee System (CR)

DEVICE CLASS: Class II

PRODUCT CODE: 87 JWH

CLASSIFICATION: 888.3560 Prosthesis, Knee, Patellofemortibial Semi-constrained, Cemented, polymer/metal/polymer
REVIEW PANEL: Orthopedics

INDICATIONS FOR USE

The Columbus Total Knee System (CR) is indicated for use in reconstruction of the diseased knee ioint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

The Columbus Knee (CR) is designed for use with bone cement.

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K020672
page 2 of 2

DEVICE DESCRIPTION

PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses" were completed. Biomechanical testing results demonstrate the Columbus Knee System is substantially equivalent to other knee systems currently on the market.

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Columbus Total Knee System is substantially equivalent to:

. Search Evolution Total Knee System (K021313)
Scorpio Posterior Cruciate Retaining Knee System (K974556) .
. Gem Knee System (K994214)

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized symbol that resembles three abstract human profiles or faces, with flowing lines suggesting movement or connection.

Public Health Service

NOV 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Joyce Kilroy Director of Regulatory Affairs/Quality Assurance Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K022672

Trade/Device Name: Columbus Total Knee System (CR) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH

Dated: August 9, 2002

Received: August 12, 2002

Dear Ms. Kilroy:

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 - Ms. Joyce Kilroy

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.

L. Mark N. 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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INDICATIONS FOR USE STATEMENT B.

Page 1 of 1

Device Name: Columbus Total Knee System (CR)

Indication for Use:

The Columbus Knee (CR) is designed to 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

(per 21 CFR 801.109)

or Over-the-Counter Use

Mark N. Mulkerson

ision of General, Rest rative and Neurologica

510(k) Number K022672

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.