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Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• · Non-inflammatory degenerative joint disease including
  • osteoarthritis
  • traumatic arthritis, and
  • avascular necrosis (not applicable to Physica TT Tibial Plate);
• · 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.

Additional indications for Physica LMC component are:

• · Moderate varus, valgus, or flexion deformities.
  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.

Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of the TT Tibial Plate that is intended for uncemented use. Tibial liners can be used with cemented tibial components.

The Physica system is a total knee replacement system consisting of a Femoral component, Tibial plate, Tibial stem and patella; the Tibial stem and Patella components are optional to be used as required for each individual patient.

Tibial liners and Patellar components made of conventional UHMWPE and cross-linked UHMWPE with Vitamin E are provided as part of the Physica system. The Tibial Plate is provided in cemented and uncemented versions.

The provided text describes a 510(k) premarket notification for the "Physica system," a total knee replacement system. It establishes substantial equivalence to predicate devices based on non-clinical testing and technological characteristics.

However, the document explicitly states that "Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices to the predicate devices."

Therefore, I cannot provide information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text. The submission relied on non-clinical testing and technological comparison for substantial equivalence.

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