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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
  • o osteoarthritis
  • o 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, PS Pro and HPS components are also indicated for:
• Absent or not-functioning posterior cruciate ligament;
• · Severe antero-posterior instability of the knee joint.

Additional indications for Physica HPS component are:

• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• 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.
• · Collagen disorders, and/or avascular necrosis of the femoral condyle.
• · Moderate varus, valgus, or flexion deformities.

AMF Revision TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon.

Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Tibial liners can be used with cemented or uncemented tibial or femoral components.

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

The Physica PS PRO Femoral component is made of CoCrMo alloy; Physica PS, PS PRO and HPS Tibial liners are made of cross-linked UHMWPE with Vitamin E.

The PS PRO Femoral component is intended to be used with bone cement.

The addition of the High Posterior Stabilized (HPS) LimaVit articular surface will provide the surgeon with a more constrained option in obtaining moderate varus/valgus and/or internal/external rotation constraint compared to Physica system posterior stabilized articular surfaces.

This document is an FDA 510(k) clearance letter for the Physica system, a knee replacement device. It primarily focuses on the device's substantial equivalence to previously cleared predicate devices through mechanical testing and a comparison of materials and intended use.

Therefore, the input does not contain information related to a study that proves a device meets acceptance criteria, especially not for an AI/software device. It lacks details regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance (e.g., country, retrospective/prospective).
• Number of experts, their qualifications, and adjudication methods for ground truth establishment.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone AI performance.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• Training set sample sizes or how their ground truth was established.

In summary, this document is a 510(k) clearance for a physical medical device (knee prosthesis), not an AI/software device. It relies on non-clinical mechanical testing and comparison to predicates, not clinical studies or performance metrics typically seen with AI/ML device clearances.

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