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The Hinged Knee is a tri-compartmental prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components. It's intended use is to allow replacement of the knee joint in which significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision or connective tissue disorders. The Hinged Knee provides joint stability when any or all of the following structures are non-functional: MCL, LCL, PCL, ACL and the iliotibial band.

The Hinged Knee is a tri-compartmental prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components.

This document is a 510(k) premarket notification for a medical device called the "Hinged Knee," a total knee replacement prosthesis. It is a regulatory approval document from the FDA, not a study report detailing acceptance criteria and performance data.

Therefore, I cannot provide the requested information because the input text does not contain details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document primarily focuses on:

• Device Description: What the Hinged Knee is (a tri-compartmental prosthesis for total knee replacement).
• Intended Use/Indications For Use: Whom it's for (patients with significant bone loss/ligamentous deficiencies due to various conditions) and what it does (provides stability when certain ligaments are non-functional).
• Predicate Device Comparison: Stating that it has comparable features to predicate devices (same indications, materials, similar geometry).
• FDA Clearance: The FDA's decision to clear the device for marketing based on substantial equivalence to pre-1976 devices, with specific limitations regarding its use (cemented use only, minimum tibial insert thickness).
• Regulatory Information: References to FDA regulations and responsibilities.

There is no mention of:

1. Acceptance criteria
2. Device performance metrics or data
3. Study design (test/training sets, sample sizes)
4. Expert involvement for ground truth
5. Adjudication methods
6. MRMC studies
7. Standalone algorithm performance
8. Type of ground truth (pathology, outcomes, etc.) for any data

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