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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.

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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The Columbus 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.

The EnduRo 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.

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 EnduRo Knee System is intended for cemented use only.

The Columbus Total Knee System AS includes both "Cruciate Retaining" (CR) and "Posterior Stabilized" (PS) variants of the femoral and tibial components for cemented use with the previously cleared UHMWPE Columbus tibial inserts and patellae. The tibial hemi-spacers (wedges) are the same design as the previously cleared Columbus Total Knee System (CRA/PSA) (K053390). All components manufactured from CoCrMo are coated with a ZrN (Zirconium nitride) coating which has been cleared in Aesculap Columbus AS Knee submission (K071220).

The EnduRo Knee System is a cemented prosthesis with a rotating hinge design. The femoral component, tibial plateau and extension stems are manufactured from CoCrMo. The tibial "gliding surfaces" (insert) and patella are manufactured from UHMWPE. The tibial mask is made from PEEK Optima® (LT1). The axial sleeve and femoral bushing components are produced from PEEK Optima® (LT1CA30). The system is made up of numerous components available in various sizes. The femoral, tibial plateau, and extension stems are also available with a ZrN (Zirconium nitride) coating. All components are sterile and for single use only.

This is a 510(k) premarket notification for two medical devices: the Columbus Total Knee System AS and the EnduRo Knee System. The document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a study of diagnostic or predictive performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, device performance, ground truth, and reader studies is not applicable or cannot be extracted from the provided text.

Here is an attempt to address the points based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not provide specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or specific mechanical thresholds with defined failure rates) that a device must meet. Instead, the "acceptance criteria" are implied by the process of demonstrating "substantial equivalence" to predicate devices and fulfilling general regulatory requirements for orthopedic devices. The "reported device performance" are statements summarizing the outcome of these evaluations, primarily asserting equivalence.

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

• Not Applicable / Not Provided: The submission is for orthopedic implants (total knee systems), not a diagnostic or predictive AI device. The "testing" mentioned refers to design verification and mechanical testing, not a clinical trial with a "test set" of patient data. Therefore, concepts like country of origin for a data test set, or whether data was retrospective or prospective, do not apply here.

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

• Not Applicable / Not Provided: As these are physical medical devices (implants) and not AI/diagnostic tools, there is no "ground truth" in the context of disease detection or prediction established by experts for a test set. The evaluation is focused on engineering and material equivalence.

4. Adjudication method for the test set

• Not Applicable / Not Provided: There is no "test set" of data or images requiring adjudication by experts 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

• Not Applicable / No: This is not an AI-assisted diagnostic device; it is a knee implant. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this submission.

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

• Not Applicable / No: This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable / Not Explicitly Stated as "Ground Truth" as defined for diagnostic AI: For these devices, "ground truth" would relate to the established mechanical and biological performance characteristics of the predicate devices, against which the new devices are compared. This involves material properties, dimensional analysis, and biomechanical testing. The reference standard for these characteristics is implicitly defined by existing regulatory standards, predicate device data, and engineering specifications, rather than clinical "ground truth" from pathology or outcomes data for diagnosis.

8. The sample size for the training set

• Not Applicable / Not Provided: These devices are not AI models that require a "training set."

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

• Not Applicable / Not Provided: These devices are not AI models that require a "training set."

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The Columbus REVISION 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 corrective valgus or varus deformity and moderate flexion contracture.

The Columbus REVISION Knee System is designed for use with bone cement.

The cemented Columbus REVISION Knee System is a semi-constrained cemented prosthesis system. The system offers femoral and tibial augments as well as stems to provide options for use during reconstructive surgery, particularly revision cases. The system is manufactured from CoCrMo with the exception of the tibial "gliding surfaces" which are manufactured from UHMWPE and the tibial mask which is made of PEEK. The system is made up of numerous components available in various sizes. All components are sterile and for single use only. All components manufactured from CoCrMo are also available with a ZrN (Zirconium nitride) coating which has been cleared in Aesculap Columbus AS Knee submission (K071220) and described in cleared Columbus Revision submission (K083772).

The provided text describes a 510(k) premarket notification for a medical device, the Columbus REVISION Knee System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or safety through clinical trials with defined acceptance criteria for device performance as would be seen in a PMA or De Novo submission.

Therefore, much of the requested information regarding acceptance criteria, specific studies proving performance against those criteria, sample sizes, expert ground truth, MRMC studies, and standalone algorithm performance, is not applicable or not present in this type of regulatory document.

However, I can extract information related to the performance data provided in the 510(k) submission.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the number of samples (individual devices or components) used for the endurance testing.
• Data Provenance: The study was "Customized endurance testing based on ASTM F 2722-08," implying it was a laboratory-based, prospective engineering test. There is no information on country of origin of data in the context of clinical studies as this was a bench test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This was a mechanical endurance test, not a clinical study requiring expert interpretation or ground truth establishment in that typical sense. The "ground truth" here is the performance of the predicate device under the same test conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This was a mechanical endurance test, not a clinical study involving human assessment and adjudication.

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 a knee implant, not an AI or diagnostic imaging device. No MRMC study was performed.

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

• Not applicable. This device is a knee implant; it does not involve algorithms or AI. The endurance testing evaluated the device's mechanical integrity on its own.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the endurance test, the "ground truth" or reference point was the performance of the legally marketed Columbus REVISION Knee System (the predicate device) under the same customized ASTM F 2722-08 test conditions. The goal was to show "similarity" rather than an absolute performance benchmark.

8. The sample size for the training set

• Not applicable. This device is a medical implant, not an AI algorithm requiring a training set.

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

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

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The Columbus Revision 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 Revision Knee System is designed to for use with bone cement.

The cemented Columbus Revision Knee System is a fixed prosthesis system that is available with one femoral design, the Posterior Stabilizing (PS) which offers stabilization it the ligament (PCL) is absent, weakened, or sacrificed during implantation. The system is manufactured from CoCrMo with the exception of the tibial "gliding surfaces" which are manufactured from UHMWPE. The complete system (femoral and tibial) makes up of numerous component available in various sizes. All components are sterile and for single use only.

This document is a 510(k) summary for the Columbus REVISION Knee System, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to previously cleared devices.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The "PERFORMANCE DATA" section (page 1, section 2) mentions:

• "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 for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses', and 'Class II Special Controls Guidance Document for Knee Joint Patellofemorotibial & . Femorotibial Metal/Polyer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA.'"

These statements indicate that specific guidance documents were followed for performance testing, but they do not provide the detailed acceptance criteria or the results of the studies themselves. To get that information, one would need to refer to the full 510(k) submission, which is not included in this extract.

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