(30 days)
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
| Acceptance Criteria (What was tested for) | Reported Device Performance |
|---|---|
| Endurance testing based on ASTM F 2722-08 for 10 million cycles | Results were found to be similar to the legally marketed Columbus REVISION Knee System (the predicate device). |
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.
§ 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.