(87 days)
Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatic 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.
Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
Hinge Knee Systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
The Columbus Total Knee System, Columbus Revision Knee System are designed for use with bone cement.
The VEGA patella is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) that incorporates a wrought stainless steel radiographic marker. The VEGA patella is intended to articulate with the femoral and tibial components of the Columbus Total Knee System, Columbus Revision Knee Svstem or EnduRo Knee System.
The VEGA patella is sterile and intended for single use only.
The provided text describes a 510(k) premarket notification for a medical device (Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System) and a line extension (VEGA patella). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance metrics in the way a diagnostic AI/ML device would.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from this type of regulatory submission. The document primarily details the device, its intended use, and its substantial equivalence to a previously cleared device.
However, I can provide information relevant to your request based on the type of data presented in this regulatory document.
Here's a breakdown of the information that can be extracted, along with explanations for categories that are not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or a quantitative study with reported results in the typical sense of a diagnostic device. Instead, the acceptance criteria implicitly relate to demonstrating substantial equivalence to a predicate device, and the "performance" data refers to assessments supporting this equivalence.
| Acceptance Criteria (Implicit from 510(k)) | Reported Device Performance (as presented in the document) |
|---|---|
| Demonstration that the VEGA patella, when used with the subject knee systems, is substantially equivalent to a legally marketed predicate device (Aesculap VEGA Knee System - K101281). | Geometrical comparison: Performed to determine cross-compatibility. |
| Evaluation of lateral stability: Performed to determine cross-compatibility. | |
| No new risks associated with the alternate use of the VEGA patella. | Results: "Results of the geometrical analysis and lateral stability demonstrated substantial equivalence and showed that there are no new risks associated with the alternate use of the VEGA patella in the subject Columbus Total Knee System (K120955), Columbus Revision Knee System (K122985), and EnduRo Knee System (K120955)." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This document refers to engineering analyses (geometrical comparison, lateral stability evaluation) rather than a clinical study with a "test set" of patients or cases. The "sample" would be the device designs themselves.
- Data Provenance: Not applicable for the reasons above. This is an engineering and design-based assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. This type of submission relies on engineering principles and regulatory assessment, not expert consensus on ground truth in a clinical context.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. There is no clinical test set requiring adjudication in this context.
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
- MRMC study: Not applicable. This document is for a knee implant system, not a diagnostic AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This document is for a medical implant, not an algorithm or AI system.
7. The type of ground truth used
- Ground truth: The "ground truth" implicitly used here is that the predicate device (Aesculap VEGA Knee System with the VEGA patella) is safe and effective when marketed. The current submission aims to demonstrate that incorporating the VEGA patella into the Columbus and EnduRo systems maintains substantial equivalence to this established "ground truth" represented by the predicate device's clearance. The assessments mentioned (geometrical comparison, lateral stability) are engineering approaches to confirm this equivalence.
8. The sample size for the training set
- Sample size for training set: Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that sense. The "development" would involve engineering design and possibly bench testing, not machine learning training.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable (not an AI/ML device).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of three human profiles facing to the right, stacked on top of each other.
May 29, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Aesculap Implant Systems, LLC Ms. Lisa M. Boyle Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K150544
Trade/Device Name: Columbus Total Knee System, Columbus Revision Knee System, EnduRo 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: May 4, 2015 Received: May 5, 2015
Dear Ms. Boyle:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150544
Device Name
Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
Indications for Use (Describe)
Columbus Total Knee System, Columbus Revision Knee System are indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatic 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.
Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
Hinge Knee Systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
The Columbus Total Knee System, Columbus Revision Knee System are designed for use with bone cement.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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B. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Columbus Total Knee System Columbus Revision Knee System EnduRo Knee System
February 24, 2015
| COMPANY: | Aesculap® Implant Systems, LLC3773 Corporate ParkwayCenter Valley, PA 18034 |
|---|---|
| ESTABLISHMENT |
REGISTRATION NUMBER: 3005673311
CONTACT:
Lisa M. Boyle 610-984-9274 (phone) 610-791-6882 (fax) lisa.boyle@aesculap.com
DEVICE
| TRADE NAMES: | Columbus Total Knee SystemColumbus Revision Knee SystemEnduRo Knee System |
|---|---|
| COMMON NAME: | Total Knee System |
| DEVICE CLASS: | CLASS II |
| PRODUCT CODE: | JWH |
| REGULATION NUMBER: | 888.3560 |
| CLASSIFICATION NAME: | Knee Joint Patellofemorotibial Polymer/Metal/PolymerSemi constrained Cemented Prosthesis |
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, LLC believes allowing the use of the previously cleared VEGA patella (K101281) with Aesculap's Columbus Total Knee System, Columbus Revision Knee System and EnduRo Knee System is a line extension that remains substantially equivalent to the currently marketed subject knee systems. There have been no changes to any of the subject components.
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DEVICE DESCRIPTION
The VEGA patella is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) that incorporates a wrought stainless steel radiographic marker. The VEGA patella is intended to articulate with the femoral and tibial components of the Columbus Total Knee System, Columbus Revision Knee Svstem or EnduRo Knee System.
The VEGA patella is sterile and intended for single use only.
INDICATIONS FOR USE
Columbus Total Knee System, Columbus Revision Knee and EnduRo Knee System are 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.
Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
Hinge Knee Systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
The Columbus Total Knee System, Columbus Revision Knee System and EnduRo Knee System are designed for use with bone cement.
TECHNOLOGICAL CHARACTERISTICS (Compared to the Predicate)
The VEGA patella is a legally marketed component of Aesculap VEGA Knee System that was originally cleared via 510(k) K101281. The introduction of the VEGA patella to the subject knee systems does not impact the fundamental scientific technology of Columbus Total Knee System (K120955), Columbus Revision Knee System (K122985), and EnduRo Knee System (K120955).
PERFORMANCE DATA
As a result of the risk analysis, a geometrical comparison and an evaluation of lateral stability were used to determine cross compatibility of Aesculap VEGA patella with Aesculap's Columbus Revision and EnduRo Knee Systems. Results of the geometrical analysis and lateral stability demonstrated substantial equivalence and showed that there are no new risks associated with the alternate use of the VEGA patella in the subject Columbus Total Knee System (K120955), Columbus Revision Knee System (K122985), and EnduRo Knee System (K120955).
§ 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.