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Administration of Intravenous fluids and drugs. The Tuta Healthcare Pty. Burette In Line (150ml) is a device used to administer fluids from a container to a patient's vascular system Through a cannula inserted into a vein.

The Tuta Healthcare Burette - In Line (150 mL) is designed administer fluids from a container to a patient's vascular system through a needle catheter inserted into a vein. The pump helps to control the rate of flow of fluids from the container to the patient. The design of the Burette - In Line (150 mL) and Baxter Healthcare's In-Line Buretrol Extension Set are similar in terms of components of , PVC tubing, roller regulators and perforators.

The provided text describes a 510(k) submission for a medical device, the Tuta's Burette - In Line (150 mL). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This is typically done through a comparison of technological characteristics and performance data.

However, the provided document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML or diagnostic device. The device described is an "Administration Set, Intravascular," which is a physical burette for fluid administration, not a software algorithm or a diagnostic tool.

Therefore, I cannot provide the requested table and details because:

• Acceptance Criteria for a diagnostic/AI device: The document discusses equivalence to a predicate device, not specific performance metrics (like sensitivity, specificity, AUC) that would be relevant for an AI/ML or diagnostic device. The "acceptance criteria" here are implied by the demonstration of substantial equivalence in performance to the predicate device in terms of flow rate and biocompatibility.
• Study proving device meets acceptance criteria (for AI/ML): The study conducted was "Laboratory bench testing" to assess flow rate and "biocompatibility testing" for materials. These are engineering and material science tests, not clinical studies with patients, experts, ground truth, or statistical analysis typically associated with evaluating AI/ML models.
• Sample size and data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set information: These are all concepts relevant to the evaluation of AI/ML or diagnostic devices, which are not applicable to the physical burette described in the document.

In summary, the provided document describes a predicate device comparison for a fluid administration set, not an AI/ML or diagnostic device with performance metrics related to accuracy or human-in-the-loop improvements.

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