Search Results

The Belmont Rapid Infuser RI-2 is designed to be used in general or alternative care environments to provide warmed blood and fluids to any patients ≥ 10 kg requiring warmed infusion from 2.5 mL/min to 1000 mL/min. - Infusion of crystalloid, colloid, or blood product, including packed red blood cells, as 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. - Infusion of warmed fluid for irrigation in urology procedures. The 3.0L reservoir is an optional accessory for use in adults only.

The Belmont® Rapid Infuser, RI-2 combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluids. The Rapid Infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set rates from 10 to 1000 milliliters per minute (mL/min). Low infusion rates of 2.5 mL/min (150 mL/hr) and 5.0 mL/min (300 mL/hr) are also available to keep the venous line open. 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 of the infusate, 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 limited to 50mL/min and safety monitoring remain active.

The provided text describes the regulatory clearance for the "Belmont Rapid Infuser, RI-2" and its substantial equivalence to a predicate device. However, it does not contain a study that quantitatively proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy (like sensitivity, specificity, accuracy, etc., which are common for AI/ML medical devices). The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device, primarily through comparison of technical specifications and non-clinical performance testing.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for test and training sets) are not explicitly present in this regulatory submission.

The acceptance criteria mentioned are related to:

• Flow rate accuracy: ± 10% from 20 – 1000 mL/min, ± 25% for 2.5, 5.0, 10 mL/min.
• Steady state fluid output temperature: 37.5°C at high flow (60 mL/min and higher); 39°C at low flow (less than 60 mL/min).
• High temperature alarm condition: Output temperature >42°C for 20 mL of fluid pumped or fluid temperature >45°C for 0.25 seconds.
• Maximum speed for steady state 37°C: 1000 mL/min.
• Pressure limit: 300 mmHg standard (user adjustable).
• High pressure alarm: At 400 mmHg.
• Battery running time: 30 minutes @ 50 mL/min.
• Compliance with various international standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62304, ISO 10993-1.

Here's the information that can be extracted, along with explanations for unavailable data:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
Not applicable/Provided. The document describes "Non-clinical performance testing" and "Bench / Performance Testing" but does not specify sample sizes for these tests in terms of patient data or clinical cases. The tests are focused on device specifications and regulatory compliance rather than statistical performance on a clinical dataset. The nature of the device (infusion pump) typically relies on engineering and laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Provided. This type of information is typically relevant for AI/ML devices where human experts establish ground truth for diagnostic or prognostic tasks. For an infusion pump, "ground truth" is established by instrument calibration and physical measurement standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Provided. This is specific to human-read diagnostic tasks.

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. This device is an infusion pump, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/relevant for this type of medical device functionality. The concept of "standalone performance" is typically applied to AI/ML algorithms performing diagnostic or analytical tasks. This device is a mechanical-electronic system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For performance parameters like flow rate, temperature, pressure, etc., the "ground truth" is established by precise physical measurements using calibrated equipment and reference standards in a laboratory setting. For safety and regulatory compliance (e.g., electrical safety, EMC, biocompatibility), the ground truth is adherence to the specified international standards.

8. The sample size for the training set:
Not applicable/Provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established:
Not applicable/Provided, as there is no training set for this type of device.

Ask a specific question about this device