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The AMSafe® Sure-Lok™ Needle-Free Connector is an accessory to an Intra-vascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein.

The AMSafe® Sure-Lok™ Needle-Free Connector is a Needle-Free connector intended for single patient use, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids used as an accessory to an Intravascular administration set without the use of a needle, thus eliminating the risk of needlestick injuries. The AMSafe® Sure-Lok™ Needle-Free Connector is a closed, Luer activated device that allows for negative fluid displacement. The AMSafe® Sure-Lok™ Needle-Free Connector individually packaged is supplied as a sterile, non-pyrogenic, single use, disposable device.

The provided text is a 510(k) Summary for the AMSafe® Sure-Lok™ Needle-Free Connector, a medical device. This document describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness in comparison to a predicate device.

Here's an analysis of the acceptance criteria and study information, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that "Bench testing of the proposed devices is performed," and tests were conducted according to various ISO and ASTM standards. However, the specific sample sizes used for each individual test or for a comprehensive "test set" are not mentioned. The document does not specify data provenance (country of origin) or if the data was retrospective or prospective, as these are bench tests rather than clinical studies with patient data.

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

This section is not applicable as the described studies are bench tests (physical and chemical testing of the device) rather than clinical studies requiring expert interpretation or ground truth establishment based on clinical observations or diagnoses.

4. Adjudication Method for the Test Set

This section is not applicable for the same reason as point 3. Bench testing adherence to standards usually relies on measurement and observation against pre-defined criteria, not expert adjudication of subjective findings.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing and biocompatibility assessments, not comparative effectiveness studies with human readers or clinical outcomes. The goal was to demonstrate substantial equivalence to a predicate device through engineering and biological testing.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is a physical medical connector, not an AI algorithm.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" is defined by the specific requirements and limits set forth in the referenced international standards (ISO, ASTM) and the manufacturer's own internal criteria. For example, for a leakage test, the ground truth is "no leakage" or leakage within a specified limit according to the standard. For biocompatibility tests, the ground truth is a lack of cytotoxic, sensitizing, or toxic effects as defined by the respective ISO standards.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there is no training set for a physical medical device.

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