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The T34L SYRINGE DRIVER is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through all 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). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.

The T34L SYRINGE DRIVER SYSTEM includes: Syringe Pump External Charger Extension Tube Bolus cable (optional)

This document is a 510(k) clearance letter from the FDA for a medical device called the "T34L Syringe Driver." It is an approval for marketing the device based on substantial equivalence to a legally marketed predicate device. This type of document does not contain the detailed acceptance criteria and study results you are asking for.

The information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance would typically be found in the 510(k) submission document itself, not in the FDA's clearance letter. The clearance letter only states that the device is substantially equivalent and can be marketed.

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

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The BodyGuard infusion Pump system is designed 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, intraarterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general 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 am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the BodyGuard Infusion Pump System and primarily focuses on the regulatory approval and indications for use. It does not provide details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device.

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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 in hospital and home care environments. The system is intended for delivery of patient controlled analgesia (PCA) The system is intended for delivery of pain therapy (EPIDURAL)

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "BodyGuard Pain Management Infusion System," indicating that the device has been found substantially equivalent to a predicate device.

The document discusses:

• The device name and regulation number.
• The indications for use of the device.
• Regulatory information regarding marketing the device.

However, it does not include any details about:

• Acceptance criteria and reported device performance.
• Sample sizes, data provenance, ground truth establishment, or expert qualifications for any studies.
• Adjudication methods.
• Comparative effectiveness studies (MRMC) or standalone algorithm performance studies.

Therefore, I cannot fulfill your request for this specific device based on the information provided.

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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 T34 SYRINGE DRIVER is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through all 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). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.

The T34 SYRINGE DRIVER SYSTEM includes: Syringe Pump Extension Tube Bolus cable (optional)

This document is a 510(k) premarket notification from the FDA for a device called the T34 SYRINGE DRIVER. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance testing, ground truth, sample sizes, or expert qualifications.

Therefore, I cannot fulfill your request for that specific information based on the provided text. The document primarily focuses on regulatory approval and indications for use.

Ask a specific question about this device

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.

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The NOA III Enteral Nutrition Pump is designed to deliver programmed doses of enteral nutrition solutions at selected rates. The pump is designed to be used in hospital and home care environments. The pump can be used in stationary and ambulatory ways.

The NOA III Enteral Nutrition System includes: Infusion Pump, Battery Charger.

The provided text is a 510(k) premarket notification letter from the FDA to Caesarea Medical Electronics Limited regarding their NOA III Enteral Nutrition Pump. It does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The document states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their submission, but the letter itself does not detail the specific performance studies or acceptance criteria.

Therefore, I cannot provide the requested information based on the input text. The document is primarily an approval letter, not a device performance report.

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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.

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