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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
  • o 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.

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.

Physica LMC Knee System is a modular knee system which consists of Physica LMC tibial liner, made of UHMWPE or LimaVit, used in combination with a Physica CR femoral component, Physica tibial plate, cemented or uncemented versions, Physica patellar component, made of standard UHMWPE or LimaVit and Physica tibial stem, that were cleared as part of the Physica Knee System in K141934, K151266 and K201084.

The Physica LMC knee system is intended to be used in patients with or without a functioning posterior cruciate ligament.

This document is a 510(k) premarket notification decision letter from the FDA regarding the Physica LMC Knee System. It is a regulatory approval document and does not contain any information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication), or clinical/non-clinical testing data to prove the device meets acceptance criteria.

The document explicitly states:

• "Non-Clinical testing was not necessary to demonstrate substantial equivalence of the Physica LMC Knee System to the predicate devices."
• "Clinical testing was not necessary to demonstrate substantial equivalence of the Physica LMC Knee System to the predicate devices."

Therefore, I cannot provide the requested information. The 510(k) summary only discusses changes to the indications for use and surgical technique, asserting substantial equivalence based on these changes to already cleared predicate devices, rather than presenting new performance data.

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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, 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 for:

• · Absent or not-functioning posterior cruciate ligament;
• · Severe antero-posterior instability of the knee joint

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 metaphysed fixation in the clinical judgment of the surgeon. Tibial and femoral cones are intended fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

The AMF Revision TT Cones are intended to be used as an optional accessory component in Total Knee Arthroplasty in combinations with the Physica tibial plate (K141934, K151266 and K152008) and Physica PS femoral component (K152008). The AMF Revision TT Cones are one-piece devices, conically shaped with cannulation all the way through the cone.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to LimaCorporate S.p.A. for a knee joint prosthesis component. It discusses:

• Device Name: AMF Revision TT Cones
• Regulation Number and Name: 21 CFR 888.3560, Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis
• Regulatory Class: Class II
• Product Codes: JWH, MBH
• Indications for Use: For use in knee arthroplasty for various conditions, including revision procedures, and specifically for patients with bone defects or poor bone quality requiring supplemental metaphyseal fixation.
• Predicate Devices: Zimmer Trabecular Metal Knee System Augments and Stryker Triathlon Tritanium Cone Augments.
• Summary of Technology Comparison: States substantial equivalence in intended use, principles of operation, design, materials, sterility, and fixation methods to predicate devices.
• Non-clinical testing: Mentions "Fatigue resistance of the Physica System with AMF Revision TT Tibial Cones" tested using an internal protocol derived from ASTM F1800.
• Clinical testing: Explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of the new AMF Revision TT Cones to the predicate devices."

Therefore, there is no information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence based on non-clinical testing and comparison to predicate devices, without the need for clinical studies as described in your request.

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