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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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