(15 days)
The Ross Embrace Enteral Pump is intended to control the delivery rate of liquid enteral feeding formulas to adult and pediatric patients requiring long- or short-term enteral nutrition support in hospitals, long term care facilities or homecare settings. The device is intended to deliver standard liquid enteral formulas or reconstituted powdered formulas that have been thoroughly mixed into solution. This device is not labeled or intended for parenteral use.
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The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Ross Embrace Enteral Pump". This type of document primarily confirms that a device is substantially equivalent to a legally marketed predicate device and does not contain the detailed study information requested in your prompt.
Therefore, I cannot extract the following information from the provided text:
- Acceptance Criteria and Reported Device Performance: This document does not specify performance acceptance criteria or report device performance against them.
- Sample size used for the test set and data provenance: No information about a test set or its data provenance is present.
- Number of experts used to establish the ground truth for the test set and qualifications: No ground truth establishment is described.
- Adjudication method for the test set: No adjudication method is mentioned.
- Multi reader multi case (MRMC) comparative effectiveness study: This type of study is not mentioned.
- Standalone (algorithm only without human-in-the-loop performance) study: This is not relevant for an enteral pump.
- Type of ground truth_ used: No ground truth is discussed.
- Sample size for the training set: No training set is mentioned as this device is not an AI/ML product.
- How the ground truth for the training set was established: Not relevant as no training set is discussed.
In summary, the provided FDA clearance letter focuses on regulatory approval based on substantial equivalence and does not include the detailed technical study information that would be found in a clinical trial report or a more comprehensive technical submission.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).