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• Infusion of crystalloid, colloid, or blood product, including packed red blood cells, as A. volume replacement for patients suffering from blood loss due to trauma or surgery.
• Infusion of warmed fluid to rewarm patients after surgery or for hypothermia. в.
• Infusion of warmed fluid for irrigation in urology procedures. ்.

The Belmont FMS2000 is for use in high blood loss surgical procedures, trauma and any situation where rapid replacement of warmed blood or replacement fluid at 10 -750 ml/min is required. It can also be used to deliver irrigation fluids at rates up to 750 ml/min.

The Belmont Fluid Management System, JMS2000, combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluid. The Belmont JMS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set rates from 10 to 750 milliliters per minute (ml/min). A low infusion rate at 2.5 ml/min (150 ml/hr) is also available without heating.

The system monitors temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid infused, temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation.

A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation and safety monitoring remain active.

The provided document is a 510(k) Premarket Notification for the Belmont Fluid Management System (FMS2000). This document describes a medical device (an infusion pump with warmer) and its equivalence to a predicate device, as required by the FDA.

Based on the content of the document, the following information regarding acceptance criteria and the study is available:

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

The document does not present a formal table of acceptance criteria with specific quantitative thresholds alongside reported device performance. Instead, it describes general capabilities and a qualitative statement of performance.

2. Sample size used for the test set and the data provenance:

The document does not specify exact sample sizes for the tests conducted (e.g., number of fluid pumping tests, warming cycles, alarm triggers, or blood samples). It states "the following tests were carried out" but doesn't quantify the repetitions or specific test conditions in detail beyond "full range of flow rate and operating conditions." The data provenance is implied to be from laboratory testing performed by Belmont Instrument Corporation. No information is provided regarding country of origin of the data or if it was retrospective or prospective, though for device performance testing, it would inherently be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to the type of device and testing described. The "ground truth" for an infusion pump's performance (e.g., flow rate accuracy, temperature accuracy, alarm function) is established by physical measurements using calibrated equipment, not by expert consensus or interpretation of ambiguous data.

4. Adjudication method for the test set:

Not applicable. The tests described involve objective measurements and comparisons against specifications, not subjective assessments 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:

Not applicable. The Belmont Fluid Management System (FMS2000) is an infusion pump, which is a physical medical device, not an AI-based diagnostic or assistive technology that would involve "human readers" or "AI assistance."

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

Not applicable for an infusion pump. The device operates automatically to infuse fluids and warm them, with monitoring and alarms. While the device's software operates standalone, the entire system is a physical device, not an "algorithm only" in the context of typical AI medical device evaluation. The "standalone performance" is essentially the device's functional performance as tested.

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

The ground truth for the performance tests (flow rate, temperature, alarm function) would be established by objective physical measurements using calibrated instruments and comparing these measurements against predetermined engineering specifications and regulatory standards. For hemocompatibility, the "Sigma Diagnostics, Plasma Hemoglobin' Procedure No. 527" was used to establish the ground truth for red cell hemolysis.

8. The sample size for the training set:

Not applicable. This device is an infusion pump, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of such a device is through its design, engineering, and manufacturing processes.

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

Not applicable, as there is no "training set" for this type of device. The specifications and design principles are based on engineering standards, physiological requirements for fluid resuscitation, and safety regulations.

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