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Physica CR 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 CR knee system is intended for cemented fixation.

The Physica CR Knee Replacement System is a total knee replacement system consisting of a femoral component, a UHMWPE tibial liner, a tibial plate, and an all polyethylene patellar component. Modular tibial stems are provide for optional use as needed. The Physica CR knee system devices are intended to be used with bone cement.
The femoral components are made of CoCrMo (ISO 5832-4 / ASTM F75). The articulating surface is polished and with symmetrical condyles. 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.
Liners are made of standard UHMWPE (ISO 5834-2 / ASTM F648). They are characterized by a concave medial and lateral hemi-plateau. 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 and all polyethylene patellar components are the tibial plates and patellar components used for the Physica KR Knee Replacement System (K141934).
Tibial stems can be optionally used and are the same as those cleared for the Physica KR knee system in K141934.

The provided text describes a 510(k) premarket notification for a medical device, the Physica CR Knee System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, much of the information typically associated with acceptance criteria and standalone studies for AI/software devices is not present.

Based on the document, here's what can be extracted and what is explicitly stated as not applicable:

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

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

This information is not applicable as no clinical or "test set" data in the context of AI/software performance is described. The "test set" mentioned in the document refers to mechanical testing of physical components. "Mechanical testing was performed on worst case components or constructs." No specific sample size for these mechanical tests is given. Data provenance is not mentioned beyond the manufacturer's location in Italy.

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)

This is not applicable. The device is a physical knee prosthesis, not an AI/software device requiring expert-established ground truth for its performance assessment.

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

This is not applicable for the same reasons as point 3.

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

There was no MRMC comparative effectiveness study done. This is not an AI-assisted device.

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

A standalone performance evaluation in the context of an algorithm or AI was not done. This is a physical knee replacement system.

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

For the mechanical testing, the "ground truth" (or reference standard) is the established engineering and biomechanical principles and standards (e.g., ISO, ASTM) that govern the performance of such medical implants, and the performance of the legally marketed predicate devices.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is a physical medical device, not an AI/software system.

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

This is not applicable for the same reasons as point 8.

Study Proving Device Meets Acceptance Criteria

The study referenced in the document to prove the device meets acceptance criteria is a series of non-clinical mechanical tests. The document states:

• "The following tests were performed on Physica CR knee system devices: Contact areas and pressures at tibio-femoral and patello-femoral interfaces; Wear testing; Constraint tests at tibio-femoral and patello-femoral interfaces."
• "Fatigue tests on the tibial plate, fatigue resistance of the tibial plate-tibial stem coupling, test on the locking strength between the tibial plate and the tibial liner and static shear test on the patella were performed for the Physica KR system and are applicable to Physica CR knee system."
• "Mechanical testing was performed on worst case components or constructs. The testing results demonstrated the device's ability to perform under expected clinical conditions."

The basis for acceptance is demonstrating substantial equivalence to predicate devices (Physica KR, Vanguard, Scorpio) through these mechanical tests and by establishing that the new device shares the same materials, intended use, and basic design features as the predicates. No clinical testing was deemed necessary for this 510(k) submission.

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