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The Quantum Blood and IV Fluid Infusion Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration in adult patients. It is intended to be used by healthcare professionals in hospital. clinical. field and transport environments to help prevent hypothenmia.

The Quantum Blood and IV Fluid Infusion Warmer is a light weight, portable, battery powered, in-line fluid warming system in which specially designed thermal IV administration tubing is integrated with a warming element. The device is prescription only. The Quantum is comprised of the following components: Controller, Battery, Charger, and Quantum thermal tubing available in two configurations: TIS (Thermal Infusion Set) and TTS-B (Thermal Transfusion Set for blood) with standard IV administration components. The microprocessor and algorithm in the Quantum Controller continually receive and assess temperature input from thermistors located on the proximal, medial and distal tubing segments. In response to this input, the Controller regulates the energy applied to the tubing to reach and/or maintain a pre-set temperature range of 38 °C ± 2 °C at delivery. A double-extrusion process results in tubing configuration with an inner tubing layer and an outer tubing layer. The warming element is in between but does not contact the fluid. Warming begins at the fluid source and continues the length of the tubing until near the point of patient entry. The TIS an TTS-B tubing perform the same function as standard IV tubing, however, when warming is desired, the TIS or TTS-B is simply connected to the Quantum Controller and the Controller is connected to the Battery. The TIS and TTS-B tubing sets are provided sterile (i.e., fluid path) for single patient use. The Controller, Battery Chargers are reusable.

Apologies, but the provided text from the FDA 510(k) summary (K181775) for the "Quantum Blood and IV Fluid Infusion Warmer" does not contain the information necessary to address your specific request about acceptance criteria and a study proving a device meets them, especially in the context of an AI/human-in-the-loop system.

This document describes a medical device (a fluid warmer) and its regulatory clearance process based on "substantial equivalence" to a predicate device. It details:

• Device Description: What the fluid warmer is, its components, and how it works.
• Indications for Use: For warming blood, blood products, and IV solutions prior to administration in adult patients to prevent hypothermia.
• Comparison to Predicate Device: Highlights similarities and differences in common name, regulation, product code, indications, intended use, user population, environment, user interface, feedback, system components, infusion temperature, fluid path, flow rate, heating method/control, power source, biocompatibility, sterilization, and product standards.
• Performance Testing Summary: Lists the various engineering, biocompatibility, electrical safety, and EMC standards the device conforms to, along with the types of tests performed (e.g., cytotoxicity, sensitization, systemic toxicity, hemolysis).

Crucially, this document does NOT discuss:

• AI/Machine Learning: There is no mention of AI, algorithms for image analysis, or any form of diagnostic or assistive AI.
• Acceptance Criteria for AI Performance: Since no AI is described, there are no AI-specific performance criteria.
• Test Sets, Training Sets, Ground Truth, Expert Consensus: These concepts relate to the validation of AI/ML models, which are not relevant to the described device or the information provided in this 510(k) summary.
• MRMC Studies or Human Reader Improvement with AI: Also irrelevant as no AI is involved.

Therefore, I cannot provide the requested information based on the given input. The document is about a hardware medical device (fluid warmer) and its regulatory pathway, not an AI-powered diagnostic or assistive tool.

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