(30 days)
The Columbus (CR) Total Knee System is intended 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 persists, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
The Columbus Knee is designed for use with bone cement.
The cemented Columbus (CR) Total Knee System 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. In addition to the standard insert design, a "deep dish" design is available for patients that may need more stability than the standard design. The "deep dish" insert has a slightly smaller range of motion to provide more restraint than the standard insert design. The gliding surfaces (inserts) and patellas are manufactured from UHMWPE.
The provided text describes the Columbus (CR) Total Knee System, a medical device. However, it does not contain information about a study that assesses device performance against specific acceptance criteria in the context of an AI/human reader comparative effectiveness study, or a standalone algorithm study.
Instead, the document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices already on the market.
Here's a breakdown of what the document does state regarding performance, and then an explanation of why the requested information cannot be extracted:
Performance Information Present in the Document:
- Acceptance Criteria and Reported Device Performance: This document states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses' were completed.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 that the Columbus (CR) Total Knee System is substantially equivalent to other knee systems currently on the market."
- Acceptance Criteria (Implied): The acceptance criteria are implicitly tied to meeting the requirements of the "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses." These guidances typically stipulate a range of mechanical and material tests (e.g., fatigue, wear, strength, corrosion) and their associated pass/fail thresholds, ensuring the new device performs at least as safely and effectively as predicate devices. The specific numerical criteria are not detailed in this summary.
- Reported Device Performance: The reported performance is that the device demonstrated substantial equivalence to predicate devices based on biomechanical testing. No specific numerical results (e.g., wear rates, fatigue cycles survived) are provided in this summary.
Why the Requested Information (Related to AI/Human Reader Studies) Cannot Be Provided from this Document:
The Columbus (CR) Total Knee System is a physical orthopedic implant. The requested information (sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types for training sets, and training set sizes) is typically relevant for software as a medical device (SaMD) or AI-powered diagnostic/interpretive systems.
This 510(k) document is for a physical medical device and therefore does not include:
- A table of acceptance criteria and the reported device performance: While generic "biomechanical testing results" are mentioned, no specific criteria or performance metrics are provided in a table format that would be applicable to an AI study.
- Sample size used for the test set and the data provenance: Not applicable to a physical implant's premarket submission for substantial equivalence.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) 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. MRMC studies are for evaluating diagnostic accuracy, particularly with AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would implicitly be compliance with engineering standards and material properties, not diagnostic classifications.
- The sample size for the training set: Not applicable. There is no AI model to train.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a premarket submission for a physical knee implant and uses "substantial equivalence" as its primary regulatory pathway, relying on compliance with established engineering standards rather than clinical performance studies involving diagnostic accuracy or AI algorithms.
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Columbus Knee System Insert
DEC 1 3 2002
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990
COLUMBUS (CR) TOTAL KNEE SYSTEM
November 10, 2002
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034 |
|---|---|
| CONTACT: | Joyce Kilroy, Director of Regulatory Affairs/Quality Assurance800-258-1946 (phone)610-791-6882 (fax)joyce.kilroy @ aesculap.com (email) |
| TRADE NAME: | Columbus (CR) Total Knee System |
| COMMON NAME: | Total Knee System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | JWH |
| CLASSIFICATION: | 888.3560 |
| REVIEW PANEL: | Orthopedics |
INTENDED USE
The Columbus (CR) Total Knee System is intended 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 persists, 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 cemented Columbus (CR) Total Knee System 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. In addition to the standard insert design, a "deep dish" design is available for patients that may need more stability than the standard design. The "deep dish" insert has a slightly smaller range of motion to provide more restraint than the standard insert design. The gliding surfaces (inserts) and patellas are manufactured from UHMWPE.
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 that the Columbus (CR) Total Knee System is substantially equivalent to other knee systems currently on the market.
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K0237-88
Page 2 of 2
SUBSTANTIAL EQUIVALENCE
Aesculap 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporațe Boulevard Rockville MD 20850
DEC 13 2002
Ms. Joyce Kilroy Director of Regulatory Affairs/ Quality Assurance Aesculap®, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K023788
Trade/Device Name: Columbus (CR) Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: November 10, 2002 Received: November 13, 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
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Page 2 - Ms. Joyce Kilroy
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.
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. 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 yours,
Sincerely yours,
Mark N. Milken
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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Special 510(k) Premarket Notification
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Columbus (CR) Total Knee System
Indication for Use:
The Columbus (CR) Total Knee System is intended 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 persists, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
The Columbus Knee is designed 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)
Mark A. Mullenn
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K023788
or Over-the-Counter Use
Prescription Use
(per 21 CFR 801.109)
(Optional Format 3-10-98)
§ 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.