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The Bair Hugger Blood/Fluid Warmer is intended to warm blood, blood products, and liquids.

The Bair Hugger Blood/Fluid Warmer consists of a warming device and a disposable set. The warming device is designed to warm blood, blood products, and intravenous liquids at flow rates of up to and including 500 ml/min. The Bair Hugger Blood/Fluid Warmer can deliver temperatures as high as and including 42°C, (temperatures in accordance with the American Association of Blood Banks (AABB) Standards for Blood Banks and Transfusion Services). Two types of sterile disposable sets are available. The disposables are composed of the same materials used in the predicate devices. The fluid warming bag, attached to the disposable set, is placed inside the warming device and contacts heated aluminum plates. Blood, blood products, and liquids pass through the warming bag and are heated as they flow through. The warming device controls the temperature of the aluminum plates, which are heated by means of electrical resistance. The device meets the requirements of UL 2601, IEC 601-1, and EN 60601.

Here's a breakdown of the acceptance criteria and study information for the Bair Hugger Blood/Fluid Warmer, based on the provided text:

Important Note: The provided document is a 510(k) Summary, which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. This type of submission generally doesn't include the detailed, extensive clinical utility studies often seen for novel devices. The "studies" mentioned here are likely bench tests and comparisons directly related to the safety and fundamental function for achieving substantial equivalence.

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes nonclinical studies rather than extensive clinical trials for efficacy.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The studies evaluated "percent hemolysis" during "flow and stop flow conditions." This suggests controlled laboratory experiments, not patient data.
   • Data Provenance: Not specified, but given the nature of the device (blood/fluid warmer), these would be in-vitro laboratory tests using blood samples, not human patient data from a specific country.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The studies mentioned (hemolysis evaluation) involve objective measurements of a physical/biological property (hemolysis percentage) rather than subjective expert interpretation for establishing a "ground truth" in the way it's used for diagnostic imaging or clinical assessment. The "ground truth" here would be the measured hemolysis itself.

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

   • Not applicable. Adjudication methods are relevant for subjective assessments (like medical image interpretation) where multiple experts might disagree. These studies involve direct physical/chemical measurements.

4. 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 medical warming device, not an AI diagnostic tool or an imaging system. Therefore, MRMC studies are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. The device itself is a standalone warming unit that performs its function without a human "in the loop" in terms of continuous algorithmic decision-making. The "study" focused on its performance characteristics directly.

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

   • Objective Measurement/Biochemical Analysis: The ground truth for the hemolysis study would be the measured percentage of hemolysis in the blood samples, determined through standard laboratory techniques.

7. The sample size for the training set:

   • Not applicable in the context of this device and the described studies. The studies are evaluating the physical performance and biological effects of the warming device itself, not training an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an algorithm.

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