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GENTAFIX is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.

Teknimed's GENTAFIX® cements with gentamicin are a family of surgical cements of various viscosities, each containing the antibiotic gentamicin. GENTAFIX® bone cements are intended for fixation of prosthetic components into bone medullar cavity in cemented arthroplasty procedures. GENTAFIX® can be used with the Teknimed's own Class I 510(k) exempt accessories: bowl and spatula, and a Vacuukit® vacuum mixing and injection system. Following are the GENTAFIX models identified based on their viscosities:

• o GENTAFIX® 1 is a high viscosity bone cement intended for digital use.
• . GENTAFIX® 3 is a low viscosity bone cement intended for syringe application.
• GENTAFIX® 3 MV is a medium viscosity bone cement intended for syringe application.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called Gentafix, a bone cement. It focuses on demonstrating substantial equivalence to a predicate device, primarily through material composition, technological characteristics, and performance testing.

However, this document does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-based medical device. The product is a physical bone cement, and the testing described (physical, chemical, mechanical, sterilization, biocompatibility) are standard tests for such a material, not for an AI/ML diagnostic or prognostic tool.

Therefore, I cannot fulfill your request based on the provided text, as it does not describe:

• Acceptance criteria for an AI/ML device.
• The reported device performance for an AI/ML device.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The document is entirely about the regulatory clearance for a bone cement, not an AI/ML system.

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