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Genesis BPS FLU-ADMIN I.V. Sets are intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter into a vein.

The tubing assembly consists of spike and drip chamber connected to tubing with a "Y" injection site and a male luer slip. Between the tubing with a "Y" injection site and a male luer slip is a roller clamp. These sets deliver 20 drops/ml, with the exception of set model 0151C which delivers 60 drops/ml. All models ending with a "C" have a check valve. All sets are vented with the exception of model 0160, which is non-vented.

The provided document is a 510(k) summary for FLU-ADMIN I.V. SETS, which are medical devices used for administering fluids. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing devices and proving that it performs similarly.

It does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria in the manner typically reported for AI/Machine Learning devices. The document primarily addresses the administrative and regulatory aspects of bringing the device to market, including:

• Applicant and Contact Information: Basic details about Genesis BPS, LLC.
• Device Information: Trade name, common/usual name, classification, and product codes.
• Predicate Device: Identification of previously cleared devices to which the FLU-ADMIN I.V. SETS are being compared (K11914 FLU VEN I.V. SETS and K843692 FLU VEN I.V. SET 0153-C).
• Device Description: A physical description of the tubing assembly components.
• Intended Use: The purpose of the device (administering fluids from a container to a patient's vascular system).
• FDA Correspondence: The FDA's letter granting substantial equivalence, which is a regulatory approval based on the comparison to predicate devices, not on a new clinical study with acceptance criteria for device performance.

Therefore, the requested information components related to acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies for specific performance metrics cannot be extracted from this document because it is a regulatory submission for substantial equivalence rather than a detailed performance study report.

The "acceptance criteria" for this type of submission are typically that the new device has the same intended use and technological characteristics as the predicate device, or that any differences do not raise new questions of safety and effectiveness. The "study" proving this is the 510(k) submission itself, which primarily relies on comparison and compliance with general controls, rather than a novel performance study against predefined numerical targets.

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The Cedic srl Intravenous Gravity Set is used for IV fluid administration. This device serves as a connection between the IV fluid container and an indwelling catheter.

The Cedic srl Intravenous Gravity Set is a universal non-DEHP tubing set that allows IV solutions to be infused into the patient in conjunction with an indwelling catheter. The drip chamber fiker precludes passage of gross particle potentially generated during spiking of the IV solution container. The vent filter is 3u aerosol microbial barrier . The device consists of a spike, drip chamber with disk filter (15 um approx.), roller clamp, latex free flash bulb injection site, and male luer slip connector (Cedie product code: F 00010) or male luer lock connector (Cedic product code: F 00027).

This document pertains to the 510(k) premarket notification for a medical device, specifically an Intravenous Gravity Set, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML performance evaluation is not applicable.

The document discusses the substantial equivalence of the Cedic srl Intravenous Gravity Set to legally marketed predicate devices. The "safety and effectiveness summary" in the original document outlines the following:

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

Note: The document broadly states "All testing of the Intravenous Gravity Set indicates that the device meets or exceeds the functional requirements for the device's intended use," without specific numerical values for acceptance criteria or detailed test results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The filing focuses on substantial equivalence based on design, components, and manufacturing processes rather than a detailed clinical trial or performance study with a specified sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This is not applicable as this is a medical device (intravenous gravity set) and not an AI/ML diagnostic tool requiring expert ground truth for image or data interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. The performance is assessed through various engineering and functional tests as listed above. The "ground truth" for this type of device is its ability to perform its intended mechanical and fluid delivery functions without issues like leaks, occlusions, or component failures.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable, as this is not an AI/ML device.

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