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The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospital, clinics and field environments, to help prevent hypothermia.

The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components: 1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The Disposable Unit is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The Disposable Unit has a standard intravenous tube extension. The Disposable Unit comprises the temperature sensors. 2. Base Unit (BU) The Base Unit controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the Base Unit; the Base Unit contains firmware (SW) and electronics (HW). 3. Connecting Cable (CC) - a cable consisting data and power wires connects between the Base Unit and the Disposable Unit to facilitate the transfer of data and electrical current.

The provided text is a 510(k) summary for a medical device (QiF Blood and Fluid Warmer). It details modifications made to a previously cleared device and asserts substantial equivalence to its predicate. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets those criteria for characteristics typically evaluated in AI/ML medical devices.

The document focuses on the physical and functional aspects of the fluid warmer, such as battery upgrades, integrated disposable units, extended shelf life, and operating conditions, with performance data centering on these hardware and software changes.

Here's why the requested information isn't present in the document:

• Type of Device: The QiF Blood and Fluid Warmer is a physical medical device (hardware with embedded software for control), not an AI/ML diagnostic or predictive algorithm. Therefore, the types of "performance data" and "acceptance criteria" discussed are related to its physical operation (e.g., heating to a set temperature, battery life, environmental robustness), rather than metrics like sensitivity, specificity, AUC, or the performance of human readers with/without AI assistance.
• Acceptance Criteria & Reported Performance: While the document has a "Risk" and "Mitigation" table and discusses "Verification endpoints," these are not presented as typical acceptance criteria with reported performance values as would be expected for an AI/ML algorithm. For example, it confirms "Warming to set point temperature" and "Warming rates" were verified, but doesn't quantify them against specific pass/fail thresholds.
• Study Design for AI/ML: The document does not describe a study involving a test set, ground truth established by experts, an adjudication method, or a multi-reader multi-case (MRMC) comparative effectiveness study, as these are methodologies relevant to AI/ML performance evaluation, not a fluid warmer.
• Training Set Information: Since this is not an AI/ML algorithm that "learns" from data, there's no concept of a "training set" for the device's core functionality as described. The software validation mentioned is traditional software testing, not machine learning model training.

In summary, the provided document does not contain the specific information you requested because the device (QiF Blood and Fluid Warmer) is not an AI/ML medical device that would be evaluated with such criteria.

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