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The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

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The provided text is a 510(k) premarket notification letter from the FDA to Belmont Instrument Corporation for their device, The Belmont® buddy lite™ Fluid Warmer. This type of document does not contain the detailed information requested regarding acceptance criteria, study design parameters (sample sizes, data provenance, expert details, adjudication methods), multi-reader multi-case studies, standalone performance, or ground truth establishment for AI/ML-based medical devices.

The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (warming blood, blood products, and intravenous solutions prior to administration to prevent hypothermia). It discusses regulatory compliance and general controls but does not present clinical study results or technical performance data in the format requested for an AI/ML device.

Therefore, I cannot extract the requested information from the provided text.

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The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called "The Belmont® buddy lite™ Fluid Warmer." This document does not describe or include information about a study that proves the device meets acceptance criteria in the manner requested, which typically refers to performance studies for software, AI, or diagnostic devices.

Instead, this letter is a regulatory approval based on the device's "substantial equivalence" to a predicate device. It confirms that the device meets certain regulatory requirements for marketing.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth as those elements are not part of this type of FDA clearance document for a medical fluid warming device.

The information on this document focuses on:

• Device Name: The Belmont® buddy lite™ Fluid Warmer
• Regulation Number/Name: 21 CFR 864.9205, Blood and Plasma Warming Device
• Regulatory Class: II
• Product Code: BSB
• Indications For Use: To warm blood, blood products, and intravenous solution prior to administration by healthcare professionals in clinical environments to prevent hypothermia.
• Basis of Approval: Substantial equivalence to legally marketed predicate devices.

The questions in the prompt are more relevant to the evaluation of AI/ML-based medical devices or diagnostic tools, which involve detailed performance studies with quantitative metrics, ground truth establishment, and often human reader studies. This document pertains to a physical fluid warming device.

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