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• 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 Belmont Fluid Management System (7MS2000) 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 FMS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at userset rates from 10 to 500 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 document describes the Belmont Fluid Management System (FMS2000), an infusion pump with a warmer. The submission is a 510(k) premarket notification for a modification to the disposable set used with the FMS2000. Therefore, the device itself (FMS2000) has not changed, and the study conducted is to verify the performance of the system with the modified disposable set and accessory kits.

Based on the provided information, I can extract the following details regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

Limitations: The document states that the FMS2000 "performed within specification" but does not explicitly list the quantitative "specifications" themselves (e.g., specific accuracy percentages for flow rate, temperature ranges, or alarm trigger thresholds).

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

The document describes "Nonclinical Tests and Results" to verify the performance. However, it does not specify the sample size for these tests (e.g., number of devices tested, number of test runs).

The data provenance is retrospective in the sense that it's a submission for a modification to an existing device (K972284), and the tests were performed by the manufacturer, Belmont Instrument Corporation. There's no information about the country of origin of the data beyond the manufacturer's location in the USA.

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

The document describes nonclinical tests performed by the manufacturer. These are likely engineering and performance tests against pre-defined specifications, not assessments requiring expert "ground truth" in the medical sense (like a radiologist interpreting images). Therefore, this information is not applicable to this type of study.

4. Adjudication Method for the Test Set:

Given that these are nonclinical performance tests, an adjudication method (like 2+1, 3+1) is not applicable. The outcome of these tests would likely be pass/fail based on whether the device's measured performance met the engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, and the aim is to evaluate reader performance with and without AI assistance. The Belmont FMS2000 is an infusion pump, and the study described is for nonclinical performance verification.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The FMS2000 is a physical medical device (an infusion pump), not an AI algorithm. "Standalone performance" in this context would refer to the device's inherent operational characteristics. The nonclinical tests described are essentially a standalone performance evaluation of the device's ability to pump, warm, and alarm according to its design specifications.

7. The Type of Ground Truth Used:

For the nonclinical performance tests, the "ground truth" would be the established engineering specifications or design requirements for the Belmont FMS2000 for parameters like:

• Flow rate accuracy
• Temperature regulation accuracy
• Alarm trigger thresholds and response times

The accuracy of the device's measurements (e.g., flow rate, temperature) would be compared against verified measurement standards.

8. The Sample Size for the Training Set:

This question is not applicable. The Belmont FMS2000 is a hardware device with microprocessor control, not a machine learning model that typically requires a "training set."

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

This question is not applicable as there is no training set for this type of device.

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A. 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.
B. Infusion of warmed fluid to rewarm patients after surgery or for hypothermia.
C. Infusion of warmed fluid for irrigation in urology procedures.

The Belmont Fluid Management System (7MS2000) 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 7MS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at userset rates from 10 to 500 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 Belmont Fluid Management System (FMS2000) is an infusion pump with a warmer designed for rapid infusion of warmed fluids in high blood loss surgical procedures, trauma, and situations requiring rapid replacement of warmed blood or replacement fluid. The reported information focuses on the nonclinical tests conducted to verify the device's performance and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size for the test set in terms of number of devices or number of test conditions run. It mentions "full range of flow rate and operating conditions" for the pumping and warming tests. The tests were non-clinical, implying they were laboratory-based tests. The country of origin for the data is implicitly the United States, as the submitting company is based in Billerica, MA, USA, and the submission is to the FDA. The testing was prospective, conducted to verify the performance of the device.

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

This information is not provided. For non-clinical performance and safety tests of this nature (pumping accuracy, warming, alarm functions, hemocompatibility), ground truth is typically established by established engineering specifications, industry standards (like ASTM F756-93 for hemocompatibility), and established medical parameters (e.g., "physiological temperature"). Human experts would be involved in designing the test protocols and evaluating the results against these objective criteria, but the document does not specify their number or qualifications as "ground truth experts" in the typical AI/diagnostic sense.

4. Adjudication Method for the Test Set:

Not applicable. The tests described are objective performance tests against predefined specifications and standards, not evaluations requiring human adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is an infusion pump/warmer, not an AI diagnostic tool that assists human readers in interpreting medical images or data. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The tests described are standalone performance tests of the device itself (hardware and embedded software) without human intervention in the continuous operation for which the performance is being measured. The device's safety features autonomously detect and alarm at unsafe conditions.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests was established by:

• Engineering Specifications: For pumping accuracy, fluid warming to target temperatures, and pressure/air detection.
• Industry Standards: Specifically, ASTM F756-93 for the assessment of hemolytic properties.
• Predefined Operating Conditions: The "full range of flow rate and operating conditions" serve as the defined parameters against which performance is measured.
• Safety Requirements: The ability to detect and alarm at unsafe conditions against predefined failure modes and operational limits.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning algorithm that requires a "training set" in the context of data-driven model development. Its functionality is based on direct engineering design and control logic.

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

Not applicable. As noted above, this device does not utilize a training set in the AI sense.

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