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The Quantum" Blood and Fluid Warming System is indicated for warming blood, blood products and intravenous solutions prior to administration in adult and pediatic patients greater than 28 days old of normal birth weight. It is intended for use by healthcare professionals in hospital, clinical, field, and transport environments to help prevent hypothermia.

The Quantum is not for use with neonates (birth to 28 days old) or infants of low birth weight.

The Quantum Blood and Fluid Warming System 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 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 laver. 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 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 and Battery Chargers are reusable.

The provided document K192325 is a 510(k) premarket notification for the "Quantum Blood and Fluid Warming System". The submission concerns a change in the Indications for Use to include pediatric patients greater than 28 days old of normal birth weight. The device itself is "identical in design and technological features" to the predicate device (K181775). Therefore, the study described here primarily addresses the safety and effectiveness of using the existing device for this expanded patient population.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The core acceptance criterion for this submission is that the Quantum Blood and Fluid Warming System effectively warms blood and fluid for pediatric patients (greater than 28 days old of normal birth weight) to a target temperature without introducing new risks or exacerbating existing risks beyond acceptable levels. The performance of the device in meeting its primary function (warming) is assumed to be equivalent to the predicate device for adult use, and the performance for pediatric use is assessed by whether the device's capabilities accommodate pediatric physiological needs regarding flow rates and volumes.

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

The document does not describe a specific clinical study with a test set of patient data. This submission is a "Special 510(k)" which generally indicates a change to a currently cleared device that does not affect its fundamental scientific technology. The primary assessment made is a risk analysis and a comparison of the device's existing specifications against the physiological requirements of the new patient population.

Therefore, there is no sample size of patients in a traditional sense, nor data provenance (country, retrospective/prospective) for a clinical test set. The "test set" here refers to the parameters of pediatric physiology (flow rates, volumes, body weights) against which the device's known performance was evaluated.

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 in the context of a traditional clinical study. The "ground truth" used here is established medical knowledge regarding pediatric physiology, resuscitation guidelines (e.g., AHA Pediatric Advanced Life Support Guidelines mentioned in the risk table), and medical device safety standards. The document doesn't specify the number or qualifications of experts who conducted this particular risk analysis, but it would typically be performed by a team including engineers, regulatory affairs specialists, and possibly medical advisors with expertise in device design and pediatrics.

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

Not applicable. There was no clinical test set requiring adjudication of patient cases or outcomes. The assessment was based on existing technical specifications and medical knowledge.

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 device is a fluid warming system, not an AI-assisted diagnostic or therapeutic device 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. This is a hardware medical device with software control, not an AI algorithm. Its performance is inherent to its design and how it delivers warmth, independent of human interaction once parameters are set, but it is always used "human-in-the-loop" as healthcare professionals administer fluids.

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

The ground truth for this submission primarily consists of:

• Established Medical Standards and Guidelines: Specifically, pediatric resuscitation guidelines (e.g., AHA Pediatric Advanced Life Support Guidelines are referenced in the risk analysis table).
• Physiological Data: Known ranges for pediatric body weights, fluid volumes, and flow rates.
• Device Specifications: The inherent technical capabilities and validated performance of the Quantum Blood and Fluid Warming System as previously cleared for adult use.
• Risk Analysis Principles: Standard methodologies for identifying, evaluating, and mitigating risks associated with medical devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set for an AI/ML model was used.

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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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