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The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or pentoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.

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The provided document is a 510(k) clearance letter from the FDA for the "Belmont Hyperthermia Pump", not an AI/ML device. Therefore, the questions related to acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data are not applicable to this document. These questions are typically relevant for AI/ML device submissions where performance is measured against ground truth and compared to human readers.

This document only states the "Indications for Use" for the device, which is: "The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician."

No performance data, acceptance criteria, or study details are provided in this regulatory letter.

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The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

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The provided text is a 510(k) premarket notification letter from the FDA to Belmont Instrument Corporation for their device, The Belmont® buddy lite™ Fluid Warmer. This type of document does not contain the detailed information requested regarding acceptance criteria, study design parameters (sample sizes, data provenance, expert details, adjudication methods), multi-reader multi-case studies, standalone performance, or ground truth establishment for AI/ML-based medical devices.

The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (warming blood, blood products, and intravenous solutions prior to administration to prevent hypothermia). It discusses regulatory compliance and general controls but does not present clinical study results or technical performance data in the format requested for an AI/ML device.

Therefore, I cannot extract the requested information from the provided text.

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The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called "The Belmont® buddy lite™ Fluid Warmer." This document does not describe or include information about a study that proves the device meets acceptance criteria in the manner requested, which typically refers to performance studies for software, AI, or diagnostic devices.

Instead, this letter is a regulatory approval based on the device's "substantial equivalence" to a predicate device. It confirms that the device meets certain regulatory requirements for marketing.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth as those elements are not part of this type of FDA clearance document for a medical fluid warming device.

The information on this document focuses on:

• Device Name: The Belmont® buddy lite™ Fluid Warmer
• Regulation Number/Name: 21 CFR 864.9205, Blood and Plasma Warming Device
• Regulatory Class: II
• Product Code: BSB
• Indications For Use: To warm blood, blood products, and intravenous solution prior to administration by healthcare professionals in clinical environments to prevent hypothermia.
• Basis of Approval: Substantial equivalence to legally marketed predicate devices.

The questions in the prompt are more relevant to the evaluation of AI/ML-based medical devices or diagnostic tools, which involve detailed performance studies with quantitative metrics, ground truth establishment, and often human reader studies. This document pertains to a physical fluid warming device.

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The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Belmont Hyperthermia Pump). This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the format you've requested. It primarily focuses on the regulatory clearance of the device based on its substantial equivalence to predicate devices, rather than detailed performance study results against specific criteria.

Therefore, I cannot extract the information required to populate your table and answer your questions.

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The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.

The Belmont Hyperthermia Pump combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid perfusion of warmed fluid. It can raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician. The system monitors fluid temperature, patient 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 pumped, output fluid temperature, target temperature, patient temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation.

The provided text describes the Belmont Hyperthermia Pump, but does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and study particulars for a medical device. This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial with performance metrics and ground truth establishment against specific acceptance criteria.

However, based on the nonclinical tests described, I can infer some aspects and present the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document mentions "nonclinical tests" but does not detail the number of units tested, the number of test scenarios, or the quantity of data generated.
• Data Provenance: Not specified. These are nonclinical (bench) tests, so there's no patient data or country of origin mentioned. The tests were conducted internally by Belmont Instrument Corporation.

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

• Not applicable. This is not a study involving expert-established ground truth for diagnostic or prognostic purposes. The performance was measured against engineering specifications and safety parameters.

4. Adjudication method for the test set

• Not applicable. This is not a study requiring adjudication of expert interpretations. Device performance was evaluated against defined engineering specifications.

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. This is a medical device (hyperthermia pump), not an AI-powered diagnostic or assistive technology for human readers.

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

• Applicable in principle, as the device operates largely autonomously to maintain temperature and flow. The "nonclinical tests" described represent standalone performance evaluations of the device's functions (pumping, warming, alarming) against its internal specifications. The document states it "performed within specification in all of the above tests."

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

• For the nonclinical tests, the "ground truth" or reference standard would be the engineering specifications and design requirements of the device for pumping accuracy, temperature control, and safety alarm thresholds.

8. The sample size for the training set

• Not applicable. This is a conventional medical device, not a machine learning or AI algorithm that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

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buddy plus™ Fluid Warmer intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

The Belmont buddy plus™ Fluid Warmer is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module which powers the heater unit and displays alarm and status messages, and a single-use disposable heat exchanger set. The power module also contains a built-in battery pack which automatically switches over to the battery operation when the AC power is disconnected. When the power is restored, the system reverts to AC power automatically, the battery charger is activated, and the battery is charged. The heating technology used is resistive heating of two plates within the heater unit. The buddy plus™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of IV fluid flow, or empty set, and a number of internal fault conditions including over-heating, loss of electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The system provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display. The sterile disposable set is placed in-line between a standard IV line at its input and a user-supplied cannula or IV infusion set at its output. The input can come from a gravity fed IV line with roller clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp. The device is intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less.

The Belmont buddy plus™ Fluid Warmer is a nonelectromagnetic blood or fluid warming device intended for warming blood, blood products, and intravenous solutions to physiological temperature prior to administration. It is designed for use by healthcare professionals in clinical environments to prevent hypothermia, specifically for applications where the flow rate is 6 liters/hour (100 ml/min) or less.

Here's a breakdown of the acceptance criteria and the study information presented:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not specify a numerical sample size for the "nonclinical tests." It only states that "the following tests were carried out."
• Data Provenance: Not specified, but the testing was conducted by Belmont Instrument Corporation, presumably in-house or through a contracted laboratory to demonstrate performance. The testing is implied to be prospective, as it was done to "verify performance" for K062774.

3. Number of Experts and their Qualifications for Ground Truth of Test Set

This type of information is not applicable to this device. The Belmont buddy plus™ Fluid Warmer is a medical device for warming fluids, and its performance and safety are typically evaluated through engineering and functional tests against established physical and safety criteria, rather than through expert consensus on qualitative assessments or diagnostic interpretation. Therefore, there are no "experts" establishing a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable for this type of device testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., image analysis) where ambiguous cases require expert resolution. The nonclinical tests described for the fluid warmer are objective, measurable performance criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and aims to assess the impact of AI assistance on human performance. The Belmont buddy plus™ Fluid Warmer is a therapeutic/supportive care device, not a diagnostic one involving human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed in the sense that the device's technical specifications and functional capabilities were tested independently to verify its performance against design requirements. The "nonclinical tests" fall under this category, evaluating the device's ability to warm fluids and its safety features directly.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective engineering specifications and safety standards. For example:

• Physiological temperature: This is a defined temperature range (e.g., 37°C ± a certain tolerance). The device's ability to achieve and maintain this temperature is measured directly.
• Alarm conditions: These are defined fault conditions, and the "ground truth" is whether the device accurately detects them and triggers the appropriate alarm.

8. Sample Size for the Training Set

This information is not applicable. The Belmont buddy plus™ Fluid Warmer is not an AI/ML-driven device that requires a training set. Its design and operation are based on conventional engineering principles of resistive heating and electronic control, not machine learning algorithms.

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

This information is not applicable for the reasons stated in point 8.

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buddy™ Fluid Warmer intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

The Belmont buddy™ Fluid Warmer is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module and a disposable set. The power module powers the heater unit and displays alarm and status messages, and a disposable set which is placed in the heater unit and through which the fluid flows. The heating technology used is resistive heating of two plates within the heater unit. The buddy™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of flow, or empty set, and a number of internal fault conditions such as electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The device provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display. The sterile disposable set is placed in-line between a standard IV line at its input and a standard IV infusion set at its output. The input can come from a bag or supplied via a standard clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp. The device is intended for low flow applications where the flow rate is 6 liter/hour (100 ml/min) or less. This premarket application describes a modification to the disposable set.

The provided document is a 510(k) Premarket Notification for the Belmont buddy™ Fluid Warmer. It describes modifications to an existing device and claims substantial equivalence to its predicate device. However, it does not contain detailed acceptance criteria, specific performance metrics, or a formal study design that would allow for a comprehensive table of acceptance criteria and reported device performance.

The document states that "In order to verify performance of the Belmont buddy™ Fluid Warmer in support of substantial equivalence, the following tests were carried out: a. Verify the ability of the system to warm cold fluids to physiological temperature. b. Verify the ability of the system to protect the patient and to detect and alarm at unsafe or ineffective operating conditions." It concludes that "Both systems perform as intended according to the specifications of the device." However, it does not explicitly list these specifications or the quantitative results of the verification tests.

Therefore, I cannot provide a table of acceptance criteria and reported device performance with numerical values, nor can I answer many of the specific questions about sample size, ground truth, or MRMC studies, as this information is not present in the provided text.

Here's a breakdown of what can be inferred or directly stated from the document, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (Inferred from testing goals):
  • Ability to warm cold fluids to physiological temperature.
  • Ability to protect the patient and to detect and alarm at unsafe or ineffective operating conditions.
• Reported Device Performance:
  • The document states that the device "performs as intended according to the specifications of the device" and is "capable of heating blood products or intravenous fluids to physiological temperature." No specific numerical performance values (e.g., target temperature range, alarm thresholds, accuracy) are provided in this summary.

2. Sample size(s) used for the test set and the data provenance

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were carried out by the manufacturer to verify performance.

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

• Number of Experts: Not applicable. The "ground truth" here would be the device's ability to meet its engineering and functional specifications, which would be assessed through objective testing and measurement, not expert interpretation of outputs in the clinical sense.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Performance was verified against device specifications and functional requirements through testing, not through expert adjudication of an output or diagnosis.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a fluid warmer, not a diagnostic AI system that would assist human readers in interpreting data.

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

• Standalone Performance Study: Yes, in a sense. The described "verification tests" would evaluate the device's ability to perform its warming and safety functions independently, without a human "in-the-loop" influencing its core operational performance. However, this is not an "algorithm-only" performance in the context of AI, but rather a functional device performance.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for this device's performance would be engineering specifications and functional requirements related to temperature regulation, alarm conditions, and fluid flow detection, verified through objective measurements and testing. This is not "expert consensus, pathology, or outcomes data" in the typical medical imaging/AI context.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a hardware fluid warmer with embedded controls, not a machine learning or AI system that requires a "training set" in the conventional sense. Its "training" would be its design, calibration, and manufacturing processes.

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

• How Ground Truth for Training Set Established: Not applicable, as there is no "training set" for this type of device. The specifications and functional requirements are established through engineering design, regulatory standards, and intended use.

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Intended Use of the Jus 2000 (Unchanged by the modification):

Infusion of crystalloid, colloid, or blood product, including packed red 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 purposes.

Intended Use of the reservoir (Unchanged by the modification):

The reservoir is used for convenience in infusing large volumes of fluid (rather than having to change individual bags.) Tubing and fittings are added, same as the existing reservoir, to be used with our current disposable set.

The Belmont 7MS2000is for use in high blood loss surgical procedures, trauma and any situation where rapid replacement of warmed blood or replacement fluid at 10 -500 ml/min is required. It can also be used to deliver irrigation fluids at rates up to 500 ml/min. The reservoir is used to increase the fluid supply capacity of the Belmont instrument 7MS2000 3-Spike disposable Set.

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 SMS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set 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 new reservoir, our own design, will be used instead of Gish Biomedical Inc. reservoir. The reservoir is used for convenience in infusing large volumes of fluid (rather than having to change individual bags.) Tubing and fittings are added, same as the existing reservoir, to be used with our current disposable set.

This document is a 510(k) premarket notification for a medical device – specifically a "Large Volume Fluid Reservoir" to be used with the Belmont Fluid Management System (FMS2000). The purpose of this notification is to demonstrate that the new reservoir is "substantially equivalent" to an already legally marketed predicate device.

The provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets them because:

• It's a "substantial equivalence" claim, not a performance study: A 510(k) primarily aims to show that a new device is as safe and effective as a predicate device, not necessarily to set and meet specific, quantitative performance acceptance criteria in the way a novel device might.
• The "study" cited is for nonclinical tests: The document mentions "nonclinical tests" (section 12) rather than a formal clinical study with human subjects, which is often what "acceptance criteria" relate to in terms of performance metrics.

Therefore, many of the requested details are not present. However, I can extract what is available.

Here's a breakdown of the information that can be extracted, and where the requested information is absent:

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

Study Information Based on Provided Text:

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

• Sample Size: Not specified. The tests are "nonclinical" and likely involved lab samples of fluids or blood, not human subjects.
• Data Provenance: Not specified, but given it's a submission to the FDA from a US company (Belmont Instrument Corporation, Billerica, Massachusetts), it's highly probable the testing was conducted in the USA.
• Retrospective/Prospective: Not applicable, as these are nonclinical laboratory tests.

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. This was a nonclinical engineering and biochemical performance test, not one requiring expert human interpretation for ground truth.

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

• Not applicable.

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 is not an AI/diagnostic imaging device, and no MRMC study was mentioned.

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

• This is not an algorithm-based device in the AI sense. The "standalone" performance refers to the device's functional tests (warming, alarming, blood compatibility).

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

• For the nonclinical tests:
  • Temperature warming: Likely instrumental measurements against known physiological temperature ranges.
  • Alarm detection: Engineering validation using simulated unsafe conditions or induced failures.
  • Blood damage: Laboratory testing for hemolysis and fragility, using established biochemical assays (e.g., 'Sigma Diagnostics, Plasma Hemoglobin' Procedure No. 527).

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

• Not applicable.

Summary of Device and Study:

The Belmont Large Volume Fluid Reservoir is an accessory for the Belmont Fluid Management System (FMS2000). The FMS2000 is an infusion pump with a warmer, designed for rapid infusion of warmed fluids (blood, IV fluids, irrigation fluids). The "study" described are nonclinical tests focused on three main areas:

1. Fluid Warming: Ensuring the system can warm cold fluids to physiological temperatures across its operational range.
2. Safety Monitoring & Alarms: Verifying the system's ability to detect and alarm for unsafe conditions, including operator errors, sensor malfunctions, and internal system failures.
3. Blood Compatibility: Assessing the new reservoir's impact on blood, specifically testing for red cell hemolysis and fragility.

The key outcome of these nonclinical tests, particularly for blood compatibility, was that the system had a "negligible effect on anticoagulated blood" as assessed by a specific diagnostic procedure. The overall conclusion of the submission is that the new reservoir is "substantially equivalent" to a previously approved reservoir.

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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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