(79 days)
The MaxOne™ IV Fluid/Blood Warmer, Model 102, is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments.
The MaxOne™ IV Fluid/Blood Warmer consists of a single reusable heating unit with controller containing an on/off switch to be used with disposable MaxOne™ Warmer Cartridges. The device is placed in-line between a standard IV drip set and a standard IV extenstion set and is designed to warm blood, blood products and intravenous liquids at flow rates of up to and including 150 mL/min. The MaxOne™ IV Fluid/Blood Warmer will deliver temperatures at 37°C to 41.5°C. The MaxOne™ IV Fluid/Blood Warmer opens up to reveal the aluminum heating plates. A disposable sterile MaxOne™ Warmer Cartridge is placed on the supporting pins of the aluminum heating plates. Blood, blood products and intravenous solutions travel through channels in the warmer cartridge, which is surrounded by heating channels and heated by means of electrical resistance.
The provided document is a 510(k) premarket notification for a medical device called the "MaxOne™ IV Fluid/Blood Warmer, Model 102." It details the device's technical specifications, intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or specific details relevant to the performance evaluation of an AI/ML powered device. This document is for a physical medical device and therefore, the following questions are not applicable.
Here's an explanation that addresses the points you've asked for, based on the provided text, and highlights why much of the requested information is not present:
Responses to your numbered points:
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A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in the way a performance study for an AI/ML device would. Instead, it describes the device's performance characteristics and uses comparison to a predicate device (Model 101) to demonstrate substantial equivalence.Performance Characteristic MaxOne™ Model 102 Reported Performance Comparison to Predicate (Model 101) Flow Rate 1 - 150 mL/min 5 - 150 mL/min (improved lower bound) Infusion Temperature 37°C - 41.5°C 33°C - 39°C (different range) Alarm Condition When temperature reaches 44°C When temperature reaches 40°C (different threshold) Note: The document only states "performance data demonstrate the temperature accuracy of the device at different flow rates" but does not provide specific temperature accuracy acceptance criteria or detailed results.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The document refers to "performance data" but does not detail the specifics of any test set (e.g., number of tests, types of fluids, different flow rates tested). Data provenance is also not mentioned, as this is a physical device and not based on data. -
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 applicable and therefore not provided. The device warms fluids. Ground truth, in the context of expert consensus, is relevant for diagnostic or AI/ML-powered devices, not for a fluid warmer. The "ground truth" for a fluid warmer would be directly measurable physical properties like temperature and flow rate accuracy, which would be measured by instrumentation, not human experts. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are used in studies where human interpretation or expert opinion is involved in establishing a ground truth, such as in diagnostic imaging algorithms. For a physical device like a fluid warmer, performance is assessed through objective measurements against technical specifications. -
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:
This information is not applicable and not provided. MRMC studies are designed to evaluate the performance of AI-assisted diagnostic tools where human readers interpret cases. This device is a fluid warmer, not a diagnostic tool, and does not involve human "readers" or AI assistance in that context. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not provided. A standalone performance evaluation is relevant for AI/ML algorithms operating independently. The MaxOne™ IV Fluid/Blood Warmer is a physical device with a "microprocessor control" and thermistors, but it's not an AI/ML algorithm in the sense that would require a separate "standalone" performance study from human-in-the-loop. Its performance is inherent to its physical operation. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance would be objective physical measurements (e.g., actual fluid temperature, flow rate, alarm activation) compared against predefined engineering specifications. It would not involve expert consensus, pathology, or outcomes data. The document states "performance data demonstrate the temperature accuracy of the device at different flow rates," implying these physical measurements were taken. -
The sample size for the training set:
This information is not applicable and not provided. Training sets are used for machine learning algorithms. This device is a physical medical device. It may have firmware or software controlled by a microprocessor, but it's not described as an AI/ML device that undergoes "training." -
How the ground truth for the training set was established:
This information is not applicable and not provided for the same reasons as point 8.
§ 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).