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The BodyGuard infusion Pump system is designed for infusion and monitoring. The pump is intended for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). Monitoring accessory currently includes Pulse Oximeter, used for non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy. The system is indicated for use with adult, pediatric and neonatal patients in hospital and home care environments.

The BodyGuard Infusion system includes: Infusion Pump (one/dual channel models) Docking Station Bolus cable (optional) Drop sensor (optional) Pulse Oximeter (optional)

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an infusion pump system. It mainly discusses regulatory aspects and indications for use. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies as you requested.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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The BodyGuard infusion Pump system is designed for infusion of continuous or intermittent delivery at medically-controlled infusion rates through clinically acceptable routes of administration (e.g. intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an arterial, regional, or surgical wound site). The system is intended for patients who require maintenance medications, analgesics, parenteral and enteral nutrition fluids, chemotherapeutic agents or PCA therapy; parenteral fluids therapy in hospital and home care environments.

The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet) Bolus cable (optional) Drop sensor (optional)

I regret to inform you that the documents you provided do not contain the specific information needed to fulfill your request.

The provided text is an FDA 510(k) clearance letter for the "BodyGuard Infusion Pump System." This letter confirms that the device is substantially equivalent to a predicate device and can be marketed. However, it does not include details about:

• Acceptance criteria for device performance.
• A study describing performance results against those criteria.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Information regarding MRMC studies, standalone performance, or training set details.

The letter focuses on the regulatory clearance process and the device's indications for use, not the detailed performance studies or the methodology behind them.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other specific questions based on the input text.

Ask a specific question about this device