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The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a single use, latex-free, Non-DEHP, gravity feed, sterile device sterilized with Ethylene Oxide Gas. It is used to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein. The EXTENSION SET will provide a tubing extension to increase the length of an I.V. set or a syringe. The Extension Set consists of various parts such as: drip chamber, luer adapter/connectors, clamp, tubing, flow controller, Y-site, latex-free injection port, needleless injection port, stopcock, flashbulb, filter and manifold.

Based on the provided text, the device is the AMSINO® I.V. ADMINISTRATION SET AND EXTENSION SET. The document is a 510(k) summary demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets new acceptance criteria. The performance data presented refers to the predicate devices and the current device's compliance with established standards and internal testing.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a structured format. Instead, it refers to the predicate devices meeting "Bench performance testing requirement according to ISO 8536-4 when appropriate and/or AMSINO's testing and acceptance criteria." The listed "performance criteria" are general categories of tests.

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

The document does not specify the sample size used for the performance tests conducted for this submission or those referenced in the predicate devices. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The "Bench performance testing" implies laboratory testing rather than human clinical trials.

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

This information is not provided in the document. The performance data relates to engineering and biological testing, not diagnostic or interpretive tasks requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing described does not involve tasks requiring adjudication.

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

No such study was conducted or mentioned. This device is an I.V. administration set, not an AI-powered diagnostic or interpretive device.

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

Not applicable. This device is a medical device for fluid administration, not an algorithm. The performance testing described is for the physical device itself.

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

For the engineering performance tests (e.g., leakage, flow rate, tensile strength), the "ground truth" would be the measurable physical parameters according to the relevant ISO standards or internal AMSINO specifications. For biocompatibility, it's based on established biological safety testing protocols. For sterility, it's the absence of viable microorganisms according to validated sterilization processes.

8. The sample size for the training set

Not applicable. This device does not involve training data or machine learning algorithms.

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

Not applicable, as there is no training set for this device.

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To administer IV fluids/medication to a patient's vascular system.

The Victus I.V. Administration and Extension Sets are single use, sterile, non-pyrogenic devices used to administer filtered intravenous solutions and/or nutritional solution to a patient's vascular system via a catheter venous site under gravity-controlled flow. When used, the purpose of the filter is for filtering solution during intravascular administration. The device may include a needle-free valve injection site/connector which eliminates the use of needle to access the set during IV administration and aids in the prevention of needlestick injuries.

This document describes a 510(k) premarket notification for Victus Intravascular (I.V.) Administration Sets and Victus I.V. Extension Sets. The submission details changes and additions to the product line, including substituting a Flow Regulator for a Roller Clamp, replacing PVC tubing, substituting a Needle-Free connector, and adding a filter and check valve to some configurations. The document asserts that these changes do not affect the safety and effectiveness of the devices.

The information provided is primarily focused on the declaration of substantial equivalence to predicate devices and the scope of the device's intended use. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested. The only mention of testing is "The VICTUS IV Extension Set and IV Administration Set have undergone Mechanical testing to verify performance," without detailing the tests, criteria, or results.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted based on the provided text, with significant gaps for the unavailable information:

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

Unfortunately, the provided text does not contain a table of acceptance criteria or specific reported device performance metrics beyond the statement "The VICTUS IV Extension Set and IV Administration Set have undergone Mechanical testing to verify performance." No quantitative results or predefined thresholds are mentioned.

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

The document does not specify the sample size used for any mechanical testing or the data provenance.

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 information is not applicable and not present as this is a mechanical medical device, not an AI or diagnostic imaging device.

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

This information is not applicable and not present. No adjudication method is mentioned for any testing.

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

This information is not applicable as this is a mechanical medical device and not an AI-assisted diagnostic device.

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

This information is not applicable as this is a mechanical medical device and does not involve an algorithm.

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

For mechanical devices, "ground truth" typically refers to established engineering standards or regulatory requirements that the device must meet (e.g., flow rate, tensile strength, sterility). The document states that the devices underwent "Mechanical testing to verify performance" and that the "Technological characteristics of the Victus Sets are substantially equivalent to the referenced predicates." This implies that the performance was compared to established standards for similar predicate devices, though the specific 'ground truth' metrics are not detailed.

8. The sample size for the training set

This information is not applicable and not present as this is a mechanical medical device, not an AI or machine learning device.

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

This information is not applicable and not present as this is a mechanical medical device, not an AI or machine learning device.

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