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The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments.

The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets PCA cable (optional) Charging cable (optional)

I am sorry, but the provided text from the U.S. Food and Drug Administration (FDA) K070718 letter and the "Indications for Use" document for the "Body Guard Infusion System" does not contain information about acceptance criteria, device performance, study details (like sample size, data provenance, ground truth, or expert qualifications), or any comparative effectiveness studies with human readers and AI.

The documents primarily consist of a 510(k) clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device, and a separate "Indications for Use" statement describing the intended purpose of the device.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study that proves the device meets these criteria based on the provided text.

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The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments.

The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet female luer) PCA cable (optional) Charging cable (optional)

The provided text is a 510(k) clearance letter from the FDA for the "BodyGuard Infusion System". It declares the device substantially equivalent to a predicate device. However, this document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the way that would be necessary to fill out the requested table and study details.

The letter explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." It is primarily focused on regulatory clearance based on substantial equivalence, not on a detailed clinical performance study report.

Therefore, I cannot extract the requested information from the provided text. The document is administrative in nature, confirming regulatory compliance rather than detailing clinical validation or performance metrics.

Ask a specific question about this device