(100 days)
Physica knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis;
- · Inflammatory degenerative joint disease including rheumatoid arthritis;
- · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed; and
- · Treatment of fractures that are unmanageable using other techniques.
In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated for:
- · Absent or not-functioning posterior cruciate ligament;
- · Severe antero-posterior instability of the knee joint.
Physica knee system is intended for cemented fixation.
Physica PS is a modular knee system which consists of a Physica PS femoral component and a Physica PS tibial liner. These devices are used in combination with a Physica tibial plate, a Physica patellar component and, if required, a Physica tibial stem that were cleared as part of the Physica KR knee system in K141934. The Physica PS knee system components are intended to be used with bone cement.
The femoral components are made of CoCrMo alloy (ISO 5832-4 / ASTM F75). The articulating surface is polished and has symmetrical condyles. The femoral component features an open box, designed to contain the post of the tibial liner, and an asymmetrical femoral cam, intended to articulate with the liner post. Conformity between the inner surface of the components and the resected bone provide stability. Two pegs (ISO 5832-12 / ASTM F1537) can be optionally attached to the femoral component if additional fixation is required. Ten (10) sizes in left and right versions are available.
Liners are made of standard UHMWPE (ISO 5834-2 / ASTM F648). They are characterized by a concave medial and lateral hemi-plateau. In its central part, the liner features a tibial post intended to articulate with the cam of the femoral component. The liner is attached to the tibial plate through a snap-fit mechanism. The anterior aspect of the liner is shaped to accommodate the patellar tendon during flexion-extension movements of the knee. Ten (10) sizes, correspondently to the tibial plate sizes, in six (6) thicknesses, are available in a symmetrical version for left and right knees.
The tibial plates, all polyethylene patellar components and the tibial stems are the same devices as used for the Physica KR Knee System (K141934) and Physica CR Knee System (K151266).
I'm sorry, but this document does not contain the information requested in your prompt. The document is an FDA 510(k) premarket notification letter and a summary of safety and effectiveness for a knee implant system. It discusses the device's indications for use, materials, and non-clinical testing performed to demonstrate substantial equivalence to predicate devices.
Specifically, it does not provide:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Information about a study involving sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods.
- Details on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information on standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for training sets or how ground truth for training was established.
The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Physica PS knee system to the predicate devices." This further confirms the absence of the type of clinical or performance study details you are asking for, which are typically associated with AI/ML device evaluations.
§ 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.