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

Device Description

The Columbus MIOS CR/PS tibial tray is a sterile, single-use device that is intended to be used with the previously cleared femoral component, insert, patella, and attachned to mechanism of the Columbus (CR) Total Knee System or with the femoral component and insert of the Columbus (PS) Total Knee System.

AI/ML Overview

The Columbus Total Knee System MIOS CR/PS Tibial Tray is a medical device. The provided text refers to a 510(k) Premarket Notification to the FDA, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with human subjects.

Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes, expert ground truth, and MRMC studies are not applicable or explicitly stated in this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly available. For 510(k) submissions for orthopedic implants, the "acceptance criteria" are typically demonstrating that the new device has similar technological characteristics and performs at least as safely and effectively as a legally marketed predicate device. This is primarily done through mechanical testing to ensure the device meets established industry standards or recognized guidance documents.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance: Meet relevant industry standards and guidance for orthopedic implants.	Testing per Guidance Documents: - "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements"- "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"- "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"- "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components"- "Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMPE) Used in Orthopedic Devices"(The text states "All required testing... were done where applicable" and lists these specific guidance documents. This implies that the device met the criteria outlined in these documents, as it received clearance.)
Material Compatibility: Use materials commonly used in medical devices and similar to predicate.	Materials Used: Base material for the Aesculap Implant Systems device is the same as predicate devices. PMMA Nano-Bond surface pretreatment uses materials commonly used on other medical devices.
Dimensional & Design Similarity: Similar shapes and sizes to predicate devices.	Similar Characteristics: "The MIOS CR/PS tibial tray is offered in similar shapes and sizes as the predicate devices."

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

Not applicable in the context of a 510(k) submission for this type of device based on the provided text. The "test set" here refers to mechanical testing of the device itself (e.g., fatigue, wear, strength), not a clinical study on human subjects. Sample sizes for such engineering tests are specified within the listed guidance documents, but not explicitly detailed in this summary. Data provenance would be from laboratory testing conducted by the manufacturer or a contracted lab. There's no mention of country of origin for such mechanical test data.

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

Not applicable. For mechanical testing, the "ground truth" is defined by the engineering specifications and performance standards outlined in the guidance documents. Expert consensus in a clinical sense is not used for this type of testing.

4. Adjudication Method for the Test Set

Not applicable. Mechanical tests have pass/fail criteria based on objective measurements against engineering standards, not through adjudication by human experts.

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 device is an orthopedic implant, not an AI-powered diagnostic tool requiring MRMC studies for human reader performance.

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

Not applicable. This device is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

For mechanical testing, the "ground truth" is the established engineering standard or performance requirement outlined in the various FDA guidance documents and recognized consensus standards (e.g., ISO, ASTM) that are referenced. It relies on objective, repeatable measurements.

8. The Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the machine learning sense. The "development" or "design" process for an implant involves engineering principles, material science, and prior knowledge from predicate devices.

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

Not applicable. As there is no "training set" for an algorithm, there's no ground truth established in this context. The design of the implant is based on established biomechanical principles, material properties, and the performance history of predicate devices.

Summary

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SEP 1 4 2007

Page 1 of 2

Columbus Total Knee System MIOS CR/PS Tibial Tray

K071499

510(k) SUMMARY (as required by 21 CFR 807.92) в.

Columbus (CR) Total Knee System(MIOS CR/PS Tibial Tray)May 31, 2007
COMPANY:	Aesculap Implant Systems Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311
CONTACT:	Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racosky@aesculap.com (email)
TRADE NAME:	Columbus Total Knee System MIOS CR/PS TibialTray
COMMON NAME:	Total Knee System
CLASSIFICATION NAME:	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
REGULATION NUMBER:	888.3560
PRODUCT CODE:	JWH

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems Inc. believes that the Columbus Total Knee System MIOS CR/PS Tibial Tray is substantially equivalent to Aesculap Implant Systems Inc. Columbus Total Knee System (K022672), Howmedica Osteonics Scorpio J ow Profile Tibial Tray (K032829), and Zimmer's Millar/Galante Precoated Total Knee (K853661).

DEVICE DESCRIPTION

INDICATIONS FOR USE

The Columbus (CR) Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, theumatoid arthritis, post-traumation of this, 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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TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

The MIOS CR/PS tibial tray is offered in similar shapes and sizes as the predicate devices. The base material used for the Aseculap Implant Systems device is the same as that used to manufacture the predicate devices. The only difference is a PMMA Nano-Bond surface pretreatment to the CoCrMo implants. The materials used in the PMMA Nano-Bond surface pretreatment are commonly used on other medical devices.

PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the

"Guidance Document for Testing Orthopedic Implants with Modified Metallic . Surfaces Apposing Bone or Bone Cement",
"Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on . Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
. "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components", and
"Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMPE) Used . in Orthopedic Devices" was completed where applicable.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

SEP 1 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap Implant Systems Inc. % Ms. Kathy A. Racosky Regulatory Affairs Specialist 3773Corporate Parkway Center Valley, PA 18034

Re: K071499

Trade/Device Name: Columbus Total Knee System MIOS CR/PS Tibial Tray 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 20, 2007 Received: August 21, 2007

Dear Ms. Racosky:

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. Kathy A. Racosky

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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Barbara Buchus

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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A. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: Columbus (CR) Total Knee System

Indications for Use:

The Columbus Knee is designed for use with bone cement.

X Prescription Use

(per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) -- Goneurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices

510(k) Nun

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.