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The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intra-arterial, epidural, and subcutaneous, to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy.

The Ivenix Large Volume Pump (LVP) is indicated for use only with the Ivenix sterile, single use, disposable administration sets, including:

Primary dual inlet, single outlet, 1 Y-site Primary single inlet, single outlet Blood Set, dual inlet, single outlet, 1 Y-site, for administration of red blood cells, platelets and plasma Microbore single inlet, single outlet, for administration of epidural fluids Microbore dual inlet, single outlet, 1 Y-site

Infusion Management System (IMS):

The IMS provides information to the clinician regarding the use of the Ivenix Large Volume Pump (LVP) by way of a drug library, LVP configurations, and by providing remote information regarding LVP status. It also provides information on pump usage data reports to various functions within an institution.

The Ivenix Infusion System (IIS) consists of three primary components:

• 1. Single channel large volume pump (LVP),
• 2. Single use, sterile, disposable fluid administration sets, and
• 3. Infusion Management System (IMS) server applications.

The Large Volume Infusion Pump (LVP) is built around a closed-loop, pneumatically driven fluid delivery mechanism. Negative pressure is used to draw liquid from the source container into an intermediate pumping chamber (IPC). Positive pressure is then used to push the liquid out of the IPC and to the patient. The pneumatic drive allows for direct measurement of volume changes in the IPC.

The pump used the ideal gas equation, P1V1 = P2V2, to accurately calculate volume of fluid delivered. Using a known reference volume, pressure measurements are taken at various intervals during the fill and empty cycles to allow the system to determine flow rate to the patient. The LVP then adjusts drive pressure and/or fluidic resistance through a variable fluidic resistor to bring the actual flow rate to match the target flow rate.

The LVP System is a dual-inlet, single-outlet delivery system that can selectively draw from up to two fluid sources and deliver either of those fluids to the patient through a single outlet. Active delivery from two inlets provides for managed intermittent and "piggy-back" infusions. The system does not support concurrent delivery of the same time. The LVP can use 5 ml to 60 ml syringes, manufactured by Becton Dickinson, B. Braun, or Covidien, directly connected to the secondary inlet of the primary and microbore administration sets as a fluid source.

The system delivers fluid through a single-use, dual-inlet, single-outlet, disposable administration set. There are five varieties of administration sets:

• 1. Primary dual inlet, single outlet, 1 Y-site
• 2. Primary single inlet, single outlet
• Blood Set, dual inlet, single outlet. 1 Y-site, for administration of red blood cells, platelets and plasma 3.
• Microbore single inlet, single outlet, for administration of epidural fluids 4.
• 5. Microbore dual inlet, single outlet, 1 Y-site

The Infusion Management System (IMS) allows the pump to share information with other pumps and applications provided by Ivenix, such as an infusate library, or other systems that reside within the hospital. In addition, the IMS provides other features, such as remote viewing dashboards, clinical analytics, and advisories that provide information about the infusion delivery both at, and away from, the point of care.

The medical device described in the provided text is an infusion pump, and the document is a 510(k) summary for its premarket notification. Infusion pumps are typically subject to performance testing against established standards, rather than clinical studies with "acceptance criteria" and "ground truth" as might be seen for diagnostic AI devices.

Based on the provided information, I can answer your questions, specifically pointing out where the concepts you've asked about (like "acceptance criteria" for accuracy, "ground truth" for training, etc.) are addressed in the context of an infusion pump's regulatory submission.

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

For an infusion pump, "acceptance criteria" primarily relate to engineering and performance specifications outlined in recognized standards and internal validation. The document compares the subject device (Ivenix Infusion System) to a predicate device (Baxter SIGMA Spectrum Infusion Pump) on various technological characteristics, which act as de-facto performance criteria for achieving substantial equivalence.

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

For the performance testing of an infusion pump, "sample size" refers to the number of devices or components (e.g., administration sets, syringes) tested under various conditions to ensure they meet their specifications. The document details that various tests were performed, but does not specify quantitative sample sizes (e.g., N=X devices tested) or the provenance of this test data (e.g., conducted internally, by a third-party lab). These are typically highly controlled engineering tests, not based on real-world patient data in the way an AI diagnostic device would be.

• Administration Set Compatibility: "Verification of the pump essential performance was completed with the indicated administration sets"
• Syringe Compatibility: "Performance testing was conducted on 5 ml to 60 ml syringes manufactured by B. Braun, Becton Dickinson, and Covidien at flow rates from 0.5 ml/hr to 20 ml/hr." The specific number of syringes or tests is not given.
• Microbial Ingress: "The sterile fluid path of the administration set was challenged, under simulated worst case conditions, at the needless access ports, the spike connection to the fluid source, and the luer connection to the patient access device, with four strains of bacteria..."
• Blood products compatibility: "Packed red blood cells, platelets, and plasma were pumped through the Ivenix device at 14 ml/hr, 350 ml/hr, and 500 ml/hr flow rates." The number of samples or trials for each condition is not stated.
• Human Factors: "The human factors studies were conducted with the intended user population, use environment and use scenarios to simulate clinical conditions." The number of participants is not specified.

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 question is not applicable in the context of an infusion pump's performance testing for regulatory clearance. Infusion pump performance is verified against technical specifications and recognized standards, not "ground truth" established by human experts in the diagnostic sense. For example, flow rate accuracy is measured by calibrated instruments, not by an expert's assessment.

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

This concept is not applicable. Adjudication methods like 2+1 or 3+1 are used in medical imaging studies to establish accurate labels (ground truth) for complex diagnostic tasks. For an infusion pump, performance is measured objectively against predefined engineering standards.

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 question is not applicable. MRMC studies are used to evaluate human reader performance with and without AI assistance for diagnostic tasks. This device is an infusion pump, not a diagnostic AI system, and therefore, such a study would not be performed for its clearance.

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

The device is an infusion pump with an "Infusion Management System (IMS)" that includes a drug library and remote monitoring features. The performance tests ("Device performance", "Software & Cybersecurity") implicitly cover the "standalone" performance of the pump's mechanical and software components in delivering fluids accurately. The "Human Factors" study assesses the human-in-the-loop performance, but this is about usability and safety, not diagnostic accuracy improvement.

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

As discussed, the concept of "ground truth" for an infusion pump's performance is different from that of a diagnostic algorithm. The "ground truth" or reference for the infusion pump's performance testing consists of:

• Established engineering specifications: E.g., flow rate accuracy within +/- 5%.
• Validated measurement methods and equipment: Use of calibrated sensors and experimental setups to objectively measure parameters like flow rate, pressure, and bolus volume.
• Recognized industry standards: Compliance with standards like IEC 60601 (electrical safety), ISO 10993 (biocompatibility), IEC 62304 (software life cycle), etc.

8. The sample size for the training set

This question is not applicable since the device is an infusion pump, which is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves its design, engineering, and manufacturing processes to meet predefined specifications.

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

Not applicable, as it's not an AI/ML device with a "training set." The "ground truth" for its development is based on engineering principles, clinical requirements for fluid delivery, and regulatory standards.

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