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Cemex Genta/Cemex Genta System/Cemex Genta System Fast bone cement is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

All Cemex Genta bone cements contain the same individual chemical constituents. The liquid components contain methylmethacrylate, N-N dimethy] p-toluidine and hydroquinone. The dry powder component contains polymethylmethacrylate, barium sulphate, benzoyl peroxide and gentamicin sulphate.

The provided text does not contain information about specific acceptance criteria with numerical performance targets for the device (Cemex Genta bone cement) or a detailed study proving its direct performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through performance testing based on established standards.

Here's a breakdown of what can be extracted and what is not available in the given document:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the format requested. The document states that "Performance testing was conducted to verify that the modified bone cement performance continue to be adequate for in vivo applications and meet the requirements of ISO5833 and ASTM 451-99." However, it does not list specific numerical acceptance criteria (e.g., tensile strength > X MPa) or the precise performance values achieved by the Cemex Genta devices against those criteria. It only states that the properties were "evaluated and found to support the substantial equivalence of the device."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the sample size used for performance testing.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "in vivo applications," which implies testing relevant to biological systems.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as the document describes performance testing of a physical medical device (bone cement) against engineering standards (ISO and ASTM), not a diagnostic or AI-driven system requiring expert-established ground truth from a test set of images or clinical cases.

4. Adjudication Method for the Test Set:

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

MRMC studies are relevant for diagnostic devices that involve human readers interpreting data, often with AI assistance. This document describes a bone cement, which is a therapeutic device. Therefore, an MRMC study was not done, and the concept of human readers improving with AI assistance is not relevant here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

This concept is also not applicable to a bone cement. The "device" itself is the bone cement, not an algorithm. Its performance is evaluated through material and mechanical testing, not as a standalone algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for evaluating the bone cement's performance was based on meeting the requirements of ISO 5833 and ASTM 451-99. These are international and American standards for "Implants for surgery – Acrylic resin cements" and "Standard Specification for Acrylic Bone Cement," respectively. These standards define the physical, chemical, and mechanical properties expected of such cements.

8. The Sample Size for the Training Set:

This information is not applicable. Bone cement is a physical product, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

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

Summary of available information regarding the study:

• Study Type: Performance testing of chemical-physical and mechanical properties, gentamicin release, and stability data.
• Purpose: To verify that the modified bone cement's performance remains adequate for in vivo applications and meets the requirements of ISO 5833 and ASTM 451-99.
• Conclusion: The properties were "evaluated and found to support the substantial equivalence of the device."
• Comparison: The modified Cemex Genta cements were found substantially equivalent to predicate devices (Cemex Genta and Cemex Genta System cleared via K033596; Cemex Genta System Fast cleared via K043403).

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