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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 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 Columbus Total Knee System AS includes both CR and PS variants of the femoral and tibial components for cemented use with the previously cleared UHMWPE Columbus tibial inserts. The Zirconium Nitrate ZrN coating is the only change to the previously cleared Columbus Total Knee System. The coated components are still made from Cobalt Chrome alloy (CoCrMo).

The provided document is a 510(k) summary and FDA clearance letter for the Columbus Total Knee System AS. It describes a medical device, a knee implant, and its substantial equivalence to previously cleared devices.

However, this document does not contain any information about a study involving acceptance criteria for device performance based on AI/algorithm performance. The "PERFORMANCE DATA" section states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications All roquired (50.mg per or Orthopedic Devices-The Basic Elements' were done where applicable." This refers to standard engineering and biocompatibility testing for orthopedic implants, not an AI-based performance study.

Therefore, I cannot fulfill your request for the specific points about acceptance criteria, reported device performance, sample sizes, ground truth establishment, or AI-related effectiveness studies, as this information is not present in the provided text.

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