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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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This device is used by an ophthalmic surgeon to extend the irrigation/aspiration syringe by use of the tubing extension set away from the cannula allowing better control of irrigation/aspiration during the ophthalmic surgical procedure. This also allows the surgeons assistant to perform the irrigation/aspiration process if needed.

The Hurricane Medical tubing extension set consists of a length of silicone tubing with huer taper hubs (one male and one female) attached to both ends.

The provided text describes a medical device, the "Tubing Extension Set" by Hurricane Medical, and its regulatory clearance as substantially equivalent to existing devices. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way one would typically describe for a software-based medical device (e.g., an AI algorithm).

The document is a 510(k) premarket notification summary and an FDA clearance letter. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed performance study with quantitative acceptance criteria for a novel device.

Therefore, for almost all the requested information, the answer will be "Not applicable" or "Information not provided in the given text."

Here's a breakdown of why based on your request:

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

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

• Not applicable / Information not provided. This document does not describe a clinical or performance study with a "test set" in the context of an AI/algorithm-driven device. The "study" mentioned is a review of existing literature and the physical properties of the device components.

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)

• Not applicable / Information not provided. No "ground truth" was established by experts for a test set in the context of this 510(k) submission. Reference is made to historical uses described by "Emery et. al." and "Jaffe et. al." in ophthalmic surgery literature.

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

• Not applicable / Information not provided. No test set or adjudication method is described.

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 / Information not provided. This device is a physical tubing extension set, not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not applicable / Information not provided. This is a physical medical device, not an algorithm.

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

• Not applicable / Information not provided. The "truth" in this submission relies on established surgical practices using similar tubing, the physical and material properties of the tubing, and sterility validation for a physical product. Not a "ground truth" as typically defined for AI performance studies.

8. The sample size for the training set

• Not applicable / Information not provided. This is a physical medical device, not an AI algorithm requiring a training set.

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

• Not applicable / Information not provided. This is a physical medical device.

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The Extension Set with Anti-Siphon Valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD® pumps.

The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for the administration of fluids or medications with the CADD-Micro® pump.

The purpose of this submission is to offer an alternative, as a matter of customer preference, to the current commercially available SIMS Deltec Extension Sets. The Extension Sets have been modified to include microbore tubing for use in microinfusions and a new compatible female luer on two of the sets. A 0.2 micron filter has been included on two of the sets and is an air eliminating filter similar to the filter on the Baxter Extension Set. An anti-siphon valve is included on one of the sets and is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.

The described device is an "Extension Set with Microbore Tubing" and variants. This 510(k) summary does not contain information typically found in an acceptance criteria table or a detailed study report for AI/ML-based medical devices. The submission concerns a standard medical device (tubing) and focuses on functional and biocompatibility testing rather than performance metrics related to AI or a "test set" in the context of an algorithm.

Therefore, I cannot provide the requested information for an AI/ML device. However, I can extract the relevant information about the functional testing performed for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not detail specific quantitative acceptance criteria or a performance table in the way one would for an AI/ML device. Instead, it states that "Functional testing performed on the sets to establish their operating parameters" and "The results of the testing indicated that the Extension Sets with Microbore Tubing function according to specification." No numerical results or specific pass/fail thresholds are provided in the summary.

2. Sample Size for the Test Set and Data Provenance

This information is not applicable. The submission refers to "functional testing" and "biocompatibility testing" of physical medical devices, not a 'test set' of data for an algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because data collection for AI/ML algorithms is not relevant here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. Ground truth, in the context of an AI/ML algorithm, involves expert labels or pathological findings. For this device, "ground truth" would be the engineering specifications and performance standards against which the functional tests were conducted. The experts would be the engineers and technicians performing the functional and biocompatibility tests, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among experts when establishing ground truth for AI/ML training or test sets. This concept does not apply to functional and biocompatibility testing of a physical medical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is used to assess the impact of AI assistance on human reader performance. This device is not an AI/ML algorithm, so such a study was not performed or necessary.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical medical device (extension set), not an algorithm. Therefore, a standalone performance study for an algorithm was not done.

7. Type of Ground Truth Used

The "ground truth" for this device would be defined by engineering specifications and performance standards. The functional testing verified whether the device performed "according to specification." Biocompatibility testing verified that "the materials used in the sets are biocompatible."

8. Sample Size for the Training Set

This information is not applicable. Training sets are used for machine learning algorithms. The design and testing of this medical device did not involve machine learning, so there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there was no training set for an algorithm.

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