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The IV Administration Sets not made with PVC are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system.

The IV Extension Sets not made with PVC may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products.

The IV Sets not made with PVC are gravity, single use, disposable, IV administration sets and extension sets. IV administration sets are used to deliver fluids from a container into a patient's vascular system. The IV extension sets are used for direct injection, intermittent infusion, continuous infusion or aspiration.

These sets may be comprised of various components, which are broadly used throughout industry including insertion spikes, drip chambers, clamps, needleless luer access devices, check valves, tubing, filters, stopcocks and luer connections (connector, adaptor).

The proposed sets have not been made with polyvinylchloride (PVC). The tubing in these sets is made of polyurethane (PUR).

I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them in the format you requested because the document is a 510(k) premarket notification for "IV Sets not made with PVC", which demonstrates substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for a novel device.

Here's why I cannot fulfill your request:

• No Acceptance Criteria for "Novel" Performance: The document aims to establish "substantial equivalence" of the new device ("IV Sets not made with PVC") to already cleared predicate devices. It doesn't set new performance acceptance criteria in the way a novel device might. Instead, it compares the proposed device's characteristics and performance testing results to those of the predicate devices and relevant industry standards (ISO, ASTM) to show they are "substantially equivalent."
• Performance is Compared, Not a Single Device's Performance Against Criteria: The "device performance" reported is a comparison of the proposed device's attributes and test results to those of the predicate devices, rather than a standalone performance metric against a set acceptance threshold.
• No Standalone Performance Study: The document explicitly states: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device." Non-clinical tests were conducted to show the proposed device performs as intended and that differences (like tubing material) do not raise new safety/effectiveness issues, but this is distinct from a standalone performance study with specific acceptance thresholds for a novel claim.
• No MRMC Study: A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is entirely irrelevant to this type of device (IV administration sets) and this type of regulatory submission (510(k) for substantial equivalence based on non-clinical testing). MRMC studies are typically for image-based diagnostic devices.
• No Explicit Test Set/Training Set: The tests listed are non-clinical, functional, and performance tests on the device itself, not a statistical study on a "test set" of patient data or "training set" of data.
• Ground Truth Irrelevance: "Ground truth" (expert consensus, pathology, outcomes data) is a concept typically applied to diagnostic or prognostic devices where a "true" condition needs to be established for comparison. For an IV set, the "ground truth" equates to whether the device meets its functional and biocompatibility requirements.

The document focuses on:

• Intended Use and Indications for Use: Showing they are substantially equivalent to the predicate devices (with slight reduction in indication for power injection).
• Technological Characteristics: Highlighting the main differences (PUR tubing and an in-line AirStop filter) and explaining why these do not raise new safety/effectiveness issues.
• Non-Clinical Performance Testing: Demonstrating the device meets relevant recognized standards (ISO, ASTM) and functional requirements (e.g., flow rate, particulate contamination, microbial ingress, biocompatibility, sterilization). These tests are designed to show the device is safe and performs as intended, similar to the predicate devices.

Therefore, I cannot provide the requested table or information because the nature of this 510(k) submission does not include the elements of acceptance criteria, standalone performance against those criteria, or a study design (test set, ground truth, experts, MRMC) as typically seen for devices making novel diagnostic or therapeutic claims. The "acceptance criteria" here are implicitly that the device performs equivalently to the predicate devices and meets relevant industry standards for safety and function.

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