Search Results

The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7mL/min.

The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the outside of the administration set tubing. The warmer includes an LED light to indicate the warmer is operating and a switch that will turn the warmer on and off. The Enteral Nutrition Warmer is reusable and provided non-sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Enteral Nutrition Warmer:

Acceptance Criteria and Device Performance

The provided 510(k) summary focuses primarily on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria derived from clinical performance trials for the proposed device's efficacy in warming enteral fluid. The "acceptance criteria" can be inferred from the comparative table where the proposed device's characteristics are presented against those of the predicate. The "reported device performance" is then what the proposed device demonstrated in the non-clinical tests.

Inferred Acceptance Criteria Table:

Study Proving Acceptance Criteria:

The document describes non-clinical tests that were performed to demonstrate that the device is capable of meeting the predicate device's specifications, particularly for the addition of enteral fluids to the intended use.

1. Sample Size for Test Set and Data Provenance:

   • The document does not specify a sample size for any "test set" in terms of cases or patients. The performance data section refers to "non-clinical tests" and a "human factors study."
   • The document implies laboratory-based, engineering performance testing rather than clinical trials with patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the traditional sense.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • This information is not provided. The study mentioned in the document is a human factors study and non-clinical performance tests, not a diagnostic study requiring expert ground truth for interpretation of cases.

3. Adjudication Method for the Test Set:

   • Not applicable, as the tests described are non-clinical engineering and human factors assessments, not diagnostic performance studies requiring adjudication of results against a ground truth from experts.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done or reported. The submission is a 510(k) for a medical device (warmer) where the primary comparison is technical specifications and safety with a predicate device, not diagnostic efficacy with or without AI assistance for human readers.

5. Standalone (Algorithm Only) Performance Study:

   • Not applicable. This device is an enteral nutrition warmer, not an AI algorithm.

6. Type of Ground Truth Used:

   • For the non-clinical tests, the "ground truth" would be the engineered specifications and measurements (e.g., target temperature ranges, maximum surface temperatures, flow rates, time to reach temperature). These are determined by physics and engineering principles, not expert consensus, pathology, or outcomes data in a clinical sense.
   • For the human factors study, the "ground truth" would relate to identifying and mitigating risks related to usability and safety, likely against established human factors engineering principles and standards.

7. Sample Size for the Training Set:

   • Not applicable. This device is a physical warmer, not a machine learning model, so there is no "training set."

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As there's no training set, there's no ground truth to establish for it in this context.

Ask a specific question about this device