(86 days)
The P.F.C. Sigma Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.
The Stabilized Plus tibial insert components are used with the existing components of the P.F.C.® Sigma Knee System. The Stabilized Plus tibial insert components have a symmetrical design which can be used for either the left or right knee. The Stabilized Plus tibial insert components have an anterior and posterior snap feature and a reinforcing pin to ensure adequate interlock to the tibial tray. The tibial insert attachment mechanism is identical to the existing TC3 tibial inserts. The Stabilized Plus tibial insert and femoral condylar geometry allow for mixing and matching of sizes: up one size, size to size, and down one size. The device is constructed of UHMWPE, and Titanium.
The provided text describes a 510(k) summary for the P.F.C. Sigma Knee System (Stabilized Plus), a semi-constrained total knee prosthesis. However, it does not contain any information about acceptance criteria or a study that proves the device meets such criteria.
The document primarily focuses on:
- Device Identification: Classification name, common name, trade name.
- Predicate Device: P.F.C.® Σ Sigma Knee System.
- Device Description: Explaining the Stabilized Plus tibial insert components, their design, attachment mechanism, and compatibility within the existing P.F.C. Sigma Knee System. Materials used (UHMWPE, Titanium) are also mentioned.
- Intended Use: The medical conditions for which the device is indicated and the requirement for use with bone cement.
- Technological Characteristics Compared to Predicate Device: Stating that all technical characteristics are identical to the predicate device, with the exception of the new Stabilized Plus tibial insert components.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, expert numbers, adjudication, MRMC, standalone performance, ground truth types), or training set information because these details are not present in the provided 510(k) summary.
The document explicitly states: "Performance Standards: No performance standards have been developed for this device." This further reinforces the absence of defined acceptance criteria or a study demonstrating adherence to them within this particular submission.
§ 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.