Search Results

ENFit enteral pump syringes PENTA ENFit TM and ENFit enteral pump syringes NUTRIFIT TM deliver nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump.

ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended for neonatal, pediatric and adult use. ENFit enteral pump syringes are single use devices.

ENFit enteral pump syringes consists of disposable enteral feeding syringes that deliver nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. ENFit enteral pump syringes are designed so that, while administering enteral solutes and medication, any accidental risk of connection to a parenteral system is prevented, through the female ENFit connector for connection to an enteral access device, designed according to the AAMI/CN3:2014 (PS) Part 3 requirements, allowing only enteral use. They have plungers, made of synthetic rubber which does not contain natural latex, in order to prevent any allergies.

The provided document for the PENTA ENFit™ and NUTRIFIT™ ENFit enteral pump syringes (K161141) outlines the acceptance criteria through compliance with various international standards and the study that proves the device meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several performance standards, and for each, it implicitly states that the device met the acceptance criteria as demonstrated by in vitro bench testing. Specific numerical performance values are not provided in this summary.

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

The document refers to "in vitro bench tests" and "performance evaluations" performed at the PENTAFERTE ITALIA S.r.l. site, Loc. Nocella SP 262, I-64012 Campli (TE) – Italy. This indicates the country of origin of the data is Italy.

The description "in vitro bench tests" implies a prospective test setup where specific tests are conducted under controlled laboratory conditions to evaluate the device against predefined standards.

The document does not specify the sample size used for the test sets in any of the performance evaluations.

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)

This information is not applicable as the evaluation involved in vitro bench testing against published international standards for medical devices and not an expert-based clinical assessment of patient data. Therefore, there was no "ground truth" derived from expert consensus on a test set of cases in the traditional sense of diagnostic or clinical performance studies.

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

This information is not applicable for in vitro bench testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess cases, and a discrepancy resolution process is needed to establish a consensus ground truth.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This document describes the premarket notification for an ENTERAL PUMP SYRINGE, which is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

This information is not applicable as this submission is for a physical medical device (enteral pump syringes), not an algorithm or AI system.

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

As indicated in point 3, the concept of "ground truth" as it applies to clinical or diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not applicable here. The performance of the device was assessed against predefined technical and safety specifications outlined in international and national standards (e.g., ISO, AAMI, EN, ASTM, EP). Compliance with these standards serves as the "truth" for device functionality and safety.

8. The sample size for the training set

This information is not applicable. This is a submission for a physical medical device. The concept of a "training set" typically applies to machine learning or AI models, which are not involved in this device's evaluation.

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

This information is not applicable as there is no "training set" for this physical medical device.

Ask a specific question about this device