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The Monoject™ Blunt I.V. Access Cannula is a sterile, lubricated plastic cannula with a female luer hub. It is used to provide access to pre-pierced IV line injection sites and pre-pierced medication vials.

The Monoject™ Blunt I.V. Access Cannula is a sterile, lubricated plastic cannula with a female luer hub. It is used to provide access to pre-pierced IV line injection sites and pre-pierced medication vials. The Monoject™ Blunt I.V. Access Cannula will be available in the following configurations: Individual Blunt Cannula; Blunt I.V. Access Cannula attached to piston syringe of 3 ml, 6ml and 12 ml sizes.

The provided document (K960982) is a 510(k) summary for the Monoject™ Blunt I.V. Access Cannula, submitted to the FDA in 1996. It outlines the device's classification, intended use, and substantial equivalence to other marketed devices.

This document describes comparative testing to demonstrate substantial equivalence, but it does not contain the information requested regarding detailed acceptance criteria, a specific study proving those criteria were met, sample sizes for test or training sets, data provenance, expert ground truth establishment, or specific performance metrics in the format of a typical AI/ML device study.

The document predates the widespread use of AI/ML in medical devices and therefore does not include the type of studies and data typically associated with AI/ML performance evaluation (e.g., standalone performance, MRMC studies, specific metrics like sensitivity, specificity, AUC).

Instead, the document focuses on mechanical and biological safety testing against existing devices.

Therefore, I cannot populate the requested table and answer the specific questions about AI/ML device performance from the provided text.

Summary of available information vs. requested information:

• Acceptance Criteria & Reported Performance: The document lists types of comparative testing (Insertion Force Test, Bend Test, Break Resistance and Resilience Test, Cytotoxicity, etc.) and states the results "will indicate that the Monoject™ Pointless Blunt l.V. Access Cannula perform equivalently to or better than the B-D Interlink Cannula product." However, it does not provide specific quantitative acceptance criteria or reported performance values for these tests (e.g., "Insertion force < X Newtons" and "Reported: Y Newtons").
• Sample Size (Test Set), Data Provenance: Not applicable for an AI/ML context; the document does not specify sample sizes for the mechanical or biocompatibility tests.
• Number of Experts, Qualifications, Adjudication Method: Not applicable as this is not an AI/ML study requiring expert ground truth.
• MRMC Comparative Effectiveness Study: No, this is not an AI/ML device.
• Standalone Performance: No, this is not an AI/ML device.
• Type of Ground Truth: Not applicable for an AI/ML context. The "ground truth" here would be the physical properties and biological reactions, measured directly, rather than expert interpretation.
• Sample Size (Training Set): Not applicable for an AI/ML context.
• How Ground Truth for Training Set was Established: Not applicable for an AI/ML context.

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