(70 days)
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
This device is indicated for use when the posterior cruciate ligament is absent or deficient.
This device is intended for use as part of a cemented or uncemented knee prosthesis.
This device is part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses.
The provided text is for a 510(k) premarket notification for a medical device, the "NexGen® Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a new, extensive clinical trial to establish novel acceptance criteria and performance against those criteria.
Therefore, the document does not contain the acceptance criteria or a study designed to prove the device meets specific performance acceptance criteria in the typical sense of a clinical or analytical validation study for a new technology with novel performance claims.
Instead, the document states:
- Non-Clinical Performance and Conclusions: "Non-clinical testing demonstrated that this device met performance requirements and is as safe and effective as the predicate device."
- Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."
This indicates that the device's acceptance was based on demonstrating equivalence to a previously cleared predicate device (Prolong™ Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component, K013991) through non-clinical testing, rather than establishing new, independent performance metrics. The implicit "acceptance criteria" here are that the new device performs equivalently to the predicate device in relevant non-clinical tests.
Since a typical performance study with defined acceptance criteria and detailed results is not present, I cannot fill out the requested table or answer the specific questions about sample size, ground truth, expert qualifications, etc., as that information is not in the provided text.
In summary, based on the provided text:
- Acceptance Criteria/Reported Device Performance: Not explicitly stated as new criteria. The device's safety and effectiveness were demonstrated by meeting "performance requirements" in non-clinical testing and being "as safe and effective as the predicate device."
- Sample size used for the test set and the data provenance: Not applicable/not provided. No clinical test set data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
- Adjudication method for the test set: Not applicable/not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. Clinical data was explicitly stated as "not needed."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical knee prosthesis, not an AI algorithm.
- The type of ground truth used: Not applicable/not provided. The comparison was to a predicate device based on non-clinical testing.
- The sample size for the training set: Not applicable/not provided. No training set is mentioned as this is not an AI device.
- How the ground truth for the training set was established: Not applicable/not provided.
The key takeaway is that for this 510(k) submission, the "study" proving the device met "acceptance criteria" was non-clinical testing demonstrating equivalence to a predicate device, as opposed to a novel performance study against new, predefined clinical metrics.
§ 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.