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The Enteral Extension Sets with ENFit small bore connectors are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition or medication from an enteral feeding syringe through to any feeding tube which will accept a connector for enteral applications.

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The provided text is a 510(k) clearance letter from the FDA for "Enteral Extension Sets." It does not contain information about the engineering details of the device's acceptance criteria, nor does it describe any study that proves the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth establishment, or human reader effectiveness from this document.

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BD UniVia™ RightFit enteral extension set is indicated for use in neonatal, pediatric and adult patients in connection with nasogastric enteral feeding tube to provide nutrition via nasal or oral gastric tube placements.

BD UniVia™ RightFit transition adapter allows connection of BD UniVia™ RightFit Extension Sets to non-BD UniVia™ RightFit enteral systems.

Enteral Extension Sets are intended to provide access from a feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in two configurations:

• Standard enteral extension sets, with a variation in tube length and diameter
• Bifurcated extension sets, which allow for medication or additional delivery without disrupting the feeding line with a variation in tube length

Enteral Extension Sets consists of flexible tubing with a purple strip on the tubing. The enteral connectors are purple in color for ease of identification of enteral feeding lines. The female connector has a tethered cap to cover the connector when not used to prevent fluid leakage. A clamp is present over the tube to stop the fluid flow as needed. Transitional Adapters allow for the connection of RightFit Enteral Extension Sets to non-enteral systems. The Transitional Adapters are available in two configurations:

• Enteral female to enteral female
• Enteral male to enteral male

The document you provided is a 510(k) summary for a medical device called "BD UniVia™ RightFit Extension Sets and Transitional Adapters." This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and it typically relies on non-clinical (bench) testing rather than clinical studies.

Therefore, many of the requested categories related to clinical trials, expert adjudication, and AI performance will not be applicable or present in this context.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document states: "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, specific numerical acceptance criteria and reported device performance values are not provided in this summary. It only lists the types of tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify the sample sizes used for each of the in vitro tests.
• Data Provenance: The studies were in vitro (bench testing), not clinical. The document does not specify the country of origin of the data beyond stating the submitter (MPS Medical, Inc.) is located in Brea, CA, USA. This would be considered prospective bench testing conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not an AI/imaging device requiring expert interpretation for ground truth. It is a physical medical device. Ground truth for its performance is established through measured physical and chemical properties in controlled lab settings against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is not an AI/imaging device requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device's performance is based on pre-determined product specifications and external standard requirements (e.g., ISO standards for biocompatibility, sterilization, and transportation/shelf life, as well as internal functional specifications for physical properties).

8. The sample size for the training set

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

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a machine learning model, there is no ground truth to establish for it in this context.

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