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Physica total knee 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, 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.

Physica knee system is intended for cemented fixation.

The Physica KR Knee Replacement System is a total knee replacement system consisting of femoral, tibial plate, tibial liner, patella, and tibial stem components; the tibial stem and patella components are optional to be used as required for each individual patient. The Physica KR knee system devices are intended to be used with bone cement.

The femoral components are made of CoCrMo alloy according to the requirements of ISO 5832-4 and ASTM F75. The articulating surface is polished and has asymmetric condyles along the sagittal plane. Conformity between the inner surface of the components and the resected bone of the distal femur and two fixation pegs provide stability. Ten (10) sizes in left and right versions are available. The tibial plates are made of Ti6Al4V alloy meeting the specifications of ISO 5832-3 and ASTM F1472. The inferior aspect of the component has a keel and an optional modular tibial stem, manufactured from Ti6Al4V alloy, provide stability. A plug manufactured from standard UHMWPE (ISO 5834-2 / ASTM F648) is used to fill the female taper hole used to attach the optional stem; the plug is removed if a stem is used. The superior portion of the tibial plate is designed to lock the tibial liner through a snap-fit mechanism; the superior surface of the plate is polished to reduce back-side wear of the liner. Ten sizes of symmetric tibial plates are available.

Liners are made of standard UHMWPE (ISO 5834-2 / ASTM F648). They are characterized by a concave medial hemi-plateau along the sagittal plane while the lateral plateau is slightly convex. The articulating hemi-plateaus are both concave along the frontal plane. 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 flexionextension movements of the knee. Ten (10) sizes, correspondently to the tibial plate sizes, in six (6) thicknesses, are available in versions for left and right knees.

Tibial stems, in three (3) lengths (20, 40, and 60mm), are made of Ti6Al4V alloy (ISO 5832-3 / ASTM F1472). They stems are 15.5mm in diameter and cylindrical in shape with longitudinal grooves intended to increase the torsional stability of the device and to facilitate the distribution of the bone cement on the device during its insertion. Three lengths are available.

The all-polyethylene patella components, in six (6) diameters (26, 29, 32, 35, 38, and 41mm), are made of standard UHMWPE (ISO 5834-2 / ASTM F648). The components have a biconvex surface to articulate with the trochlear groove of the femoral component. The inferior surface has three (3) pins / pegs and a cement pocket to aid in fixation.

This is a 510(k) premarket notification for the Physica KR knee system, a Class II medical device. The document states that clinical testing was not necessary to demonstrate substantial equivalence to predicate devices, meaning that no human clinical trials were conducted to establish efficacy or safety for this specific submission. The information provided focuses on non-clinical (mechanical) testing only.

Therefore, many of the requested categories related to clinical study design, acceptance criteria based on human performance, expert ground truth, and patient data provenance cannot be extracted from this document as no such studies were performed for this submission.

Here is the information from the document regarding the non-clinical testing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria. Instead, it indicates that "The testing results demonstrated the device's ability to perform under expected clinical conditions." For a 510(k) submission based on substantial equivalence, the performance is generally benchmarked against the predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "Mechanical testing was performed on worst case components or constructs." However, it does not specify the exact sample sizes (number of components or constructs) for each test. Data provenance is not applicable as this concerns mechanical bench testing, not human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This was mechanical bench testing, not a study requiring expert clinical assessment or ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This was mechanical bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No clinical studies were conducted, and this is a physical medical device, not an AI/software product.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For mechanical testing, the "ground truth" would be established engineering standards, material properties, and expected biomechanical performance metrics (e.g., fatigue limits, wear rates, force limits) derived from predicate devices or established biomechanical principles. The document states the tests "demonstrated the device's ability to perform under expected clinical conditions," implying these standards were met.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device.

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