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The ETEX Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

The ETEX Mixing and Delivery System is comprised of a commercially available disposable medical piston syringe (syringe barrel with female luer, plunger). The ETEX Mixing and Delivery System is provided sterile, for single use only.

Here's a breakdown of the acceptance criteria and study information for the ETEX Mixing and Delivery System, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

• Sample Size for Test Set and Data Provenance: The document states that "All testing was performed on test units representative of finished devices." However, it does not specify the exact number of units tested for each criterion, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective).
• Number of Experts for Ground Truth and Qualifications: Not applicable. This device is a piston syringe, and the testing performed relates to its physical performance rather than diagnostic accuracy or human interpretation. Therefore, expert ground truth as typically defined for medical image analysis or similar tasks is not relevant here.
• Adjudication Method for Test Set: Not applicable. The tests performed are engineering performance tests, not studies requiring expert adjudication.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is typically conducted for diagnostic devices or AI systems where human reader performance is being evaluated, often with and without AI assistance. This device is a mechanical delivery system.
• Standalone (Algorithm Only) Performance Study: Not applicable. This device is a physical, mechanical system, not an algorithm.
• Type of Ground Truth Used: The "ground truth" for the tests performed would be defined by the pre-specified limits or requirements for each performance characteristic (e.g., a specific volume range for "Volume Verification," a minimum force for "Separation Force Testing," or absence of leaks for "Liquid Leak Testing"). These are engineering specifications.
• Sample Size for Training Set: Not applicable. This device is a physical product and does not involve machine learning or an "algorithm" in the sense that would require a training set.
• How Ground Truth for Training Set was Established: Not applicable, as no training set was used.

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