(167 days)
The Medical Solutions PIV IV Bag Warmer and Pressure Infusor is designed to hold and heat IV fluid bags and maintain temperatures to 980 F ( 3°F). It is also a pressure infusor designed to be inflated to increase pressure on the IV bag to assist the infusion of fluid.
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This is a Premarket Notification (510k) document for a Medical Solutions PIV System. This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, as typically found in clinical trial reports or validation studies.
Here's how this document relates to your request:
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A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria or specific reported device performance metrics in the way a study report would. It states the "Indications for Use" which specify its intended function: "designed to hold and heat IV fluid bags and maintain temperatures to 98°F (±3°F). It is also a pressure infusor designed to be inflated to increase pressure on the IV bag to assist the infusion of fluid." This implies the performance criteria would revolve around maintaining that temperature range and effectively increasing pressure for infusion. However, no specific data demonstrating compliance with these performance metrics is presented.
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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): No information about a "test set" sample size or data provenance is provided. 510(k) submissions typically rely on a demonstration of "substantial equivalence" to a predicate device, which may involve bench testing and comparisons, but the specifics of such testing (including sample sizes) are not detailed in this high-level approval letter.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not pertain to studies involving expert-established ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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. The device is a "PIV IV Bag Warmer and Pressure Infusor," not an AI diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as this is a hardware device for fluid warming and infusion, not a diagnostic or AI-driven system requiring a "ground truth" in the typical sense. Performance would be based on engineering specifications and physical measurements (e.g., temperature accuracy, pressure range).
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The sample size for the training set: Not applicable. The device is not an AI/machine learning system that requires a training set.
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How the ground truth for the training set was established: Not applicable.
In summary: This document is an FDA 510(k) clearance letter, indicating that the device has been deemed "substantially equivalent" to a legally marketed predicate device. This regulatory clearance process does not typically involve the detailed breakdown of study design, acceptance criteria, and performance metrics as requested, which would be found in a more comprehensive clinical or validation study report if one were performed and publicly available. The information provided is sufficient for regulatory approval based on the 510(k) pathway but not for a detailed scientific study analysis.
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