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The AMSafe® NeuFloTM Needleless Connector are intended to use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

Device Description

AMSafe® NeuFlo™ Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set.

AI/ML Overview

The provided text is a 510(k) summary for the AMSafe® NeuFlo™ Needleless Connector. This document outlines the device's characteristics, its comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.

However, the provided text does not describe a study involving an AI/Machine Learning device, nor does it detail a study that proves a device meets acceptance criteria in the context of AI/ML performance metrics like sensitivity, specificity, or reader studies.

Instead, it details the acceptance criteria and results for a physical medical device. The criteria are based on compliance with established ISO standards and other tests to confirm physical, chemical, and biological performance. The "performance" described refers to the functionality and safety of the needleless connector itself, not AI model performance.

Therefore, I cannot fulfill the request as it pertains to AI/Machine Learning evaluation criteria, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or training set ground truth establishment in the context of an AI/ML device.

The document speaks to the following for the physical medical device:

1. A table of acceptance criteria and the reported device performance:

The document provides a table under "g) Summary of Non-clinical testing (Bench)" listing tests, methods, acceptance criteria, and conclusions (Pass/Fail).

Test	Method	Acceptance Criteria	Conclusion
Physical Performance test
Leakage Test	ISO8536-4	ISO8536-4	Pass
Luer adapter connection	ISO80369-7	ISO80369-7	Pass
Free Flow rate	ISO8536-4	ISO8536-4	Pass
Particulate contamination	ISO8536-4	ISO8536-4	Pass
Chemical performance test
Reducing matter	ISO8536-4	ISO8536-4	Pass
Metal ions	ISO8536-4	ISO8536-4	Pass
Titration acidity or alkalinity	ISO8536-4	ISO8536-4	Pass
Residue on evaporation	ISO8536-4	ISO8536-4	Pass
UV absorption of extract solution	ISO8536-4	ISO8536-4	Pass
EO residual test	ISO10993-7	≤10µg/g	Pass
Biological performance test
Sterility test	ISO8536-4	ISO8536-4	Pass
Pyrogenicity	ISO8536-4	ISO8536-4	Pass
Biocompatibility test
In vitro cytotoxicity test	ISO10993-5	ISO10993-5	Pass
Skin sensitization test 0.9% sodium chloride injection extract	ISO10993-10	ISO10993-10	Pass
Skin sensitization test sesame oil extract	ISO10993-10	ISO10993-10	Pass
Intracutaneous reactivity test 0.9% sodium chloride injection extract	ISO10993-10	ISO10993-10	Pass
Acute systemic toxicity test sesame oil extract	ISO10993-11	ISO10993-11	Pass
Pyrogen test 0.9% sodium chloride injection extract rabbit	ISO10993-11	ISO10993-11	Pass
Bacteria endotoxins test Gel-Clot technique	USP 43-NF	USP 43-NF	Pass
Subchronic systemic toxicity test	ISO10993-11	ISO10993-11	Pass
In Vitro hemolytic properties test	ISO10993-4	ISO10993-4	Pass

For the other points (2-9), as explained, the document pertains to a physical medical device and its compliance with standards, not an AI/ML device performance study. Thus, no information is available regarding:

Sample size used for the test set and data provenance (in an AI/ML context).
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone (algorithm only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc. for an AI/ML model).
Sample size for the training set.
How the ground truth for the training set was established.

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