(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- Acceptance Criteria and Reported Device Performance: This document states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses' were completed.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- Acceptance Criteria (Implied): The acceptance criteria are implicitly tied to meeting the requirements of the "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses."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.
§ 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.