(62 days)
The ComfortMate™ Fluid Warming System is intended to be used for the warming of fluids prior to administration.
The ComfortMate™ Fluid Warming System is designed to warm fluids to 30℃ to 37℃ prior to patient administration, at flow rates of up to 200 ml/min. The ComfortMate™ consists of a reusable fluid warming unit and a single-use warmer disposable. To use the ComfortMate™, the warmer disposable is inserted into the warming unit. Once the warming unit's door is closed, the warmer disposable comes into contact with the warming unit heater plates. Fluids are warmed as they flow through the disposable. The knob on the front panel allows the user to choose from 9 temperature comfort settings. The ComfortMate™ has not been validated for the warming of blood or blood products.
The provided document is a 510(k) premarket notification for the ComfortMate™ Fluid Warming System. This type of document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, rather than a detailed study report proving device performance against specific acceptance criteria in a research setting. Therefore, many of the requested details about a study evaluating AI or specific acceptance criteria performance are not directly applicable or available in this document.
However, I can extract information related to the device's intended performance and the general safety and effectiveness statement.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in the format typically seen for a new scientific study with specific metrics (e.g., sensitivity, specificity, accuracy). Instead, it describes functional characteristics that the device is designed to meet and states that verification testing confirmed these.
| Acceptance Criteria (Inferred from Device Description) | Reported Device Performance (From F. Safety Summary and 4. Does descriptive or performance information demonstrate equivalence?) |
|---|---|
| Warm fluids to 30℃ to 37℃ | "design verification testing indicate that the ComfortMate™ Warming Unit and Disposable function as intended" and "The results of this testing indicate that the ComfortMate™ system is safe and effective for its intended use." This implies the temperature range was met. |
| Operate at flow rates of up to 200 ml/min | "design verification testing indicate that the ComfortMate™ Warming Unit and Disposable function as intended" and "The results of this testing indicate that the ComfortMate™ system is safe and effective for its intended use." This implies the flow rate was met. |
| Safe and effective for intended use | "The ComfortMate™ verification testing rigorously tested the features of the ComfortMate™ system. The results of this testing indicate that the ComfortMate™ system is safe and effective for its intended use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the "design verification testing" or the "ComfortMate™ verification testing." It also does not provide details on the data provenance, such as country of origin or whether the testing was retrospective or prospective. This information is typically found in detailed test reports, not in a 510(k) summary.
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)
This information is not provided. The document refers to "design verification testing" and "ComfortMate™ verification testing" as the basis for its safety and effectiveness claims. The establishment of ground truth by independent experts with specific qualifications is not mentioned, as this is a device performance test, not a diagnostic or AI-based assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/not provided. This type of adjudication method is used in studies where multiple human readers assess a case, typically for diagnostic accuracy. The testing described here is for the functional performance of a fluid warming device.
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 ComfortMate™ Fluid Warming System is a medical device for warming fluids, not an AI or diagnostic application. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The ComfortMate™ Fluid Warming System is a physical device that functions with human interaction (loading disposable, setting temperature), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the ComfortMate™ Fluid Warming System's performance would be based on objective physical measurements during the "design verification testing." This would likely involve:
- Temperature measurements: Using calibrated thermometers to verify that fluids reach and maintain the specified temperature range (30℃ to 37℃).
- Flow rate measurements: Using flow meters to verify that the device can handle flow rates up to 200 ml/min.
- Safety mechanism testing: Verifying the proper function of alarms, cut-offs, and other safety features.
It does not rely on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would.
8. The sample size for the training set
Not applicable. This device is not an AI system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. This device is not an AI system that requires a "training set."
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).