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The NeoMed Dual Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to sample blood, monitor blood pressure, or administer fluids intravenously.

The NeoMed Dual Lumen Umbilical Catheter is a silicone dual lumen catheter with natural white barium sulfate included for radiopacity. The device consists of the following main components: a dual lumen umbilical catheter, a hub, and two extension legs, one with a three-way stopcock and the other with an injection site.

This document describes the NeoMed Dual Lumen Umbilical Catheter and its substantial equivalence to a predicate device. It does not contain information about an AI device, therefore, the requested information about acceptance criteria, study details, ground truth establishment, or sample sizes related to AI performance cannot be provided.

The document focuses on the regulatory clearance of a medical device based on its similarity to an existing device (predicate device). The "performance data" mentioned refers to design verification tests demonstrating that the new catheter performs its intended use and is equivalent to the predicate device, not performance against specific acceptance criteria for an AI algorithm.

To explicitly address the numbered points:

1. A table of acceptance criteria and the reported device performance
   • Not applicable as this document is not about an AI device or a study with specific performance metrics against acceptance criteria. The document states, "Bench testing has demonstrated that the NeoMed Dual Lumen Umbilical Catheter is functionally equivalent to predicate NeoMed Single Lumen Umbilical Catheter and that any minor differences do not affect safety or effectiveness." and "Design verification performance test results demonstrate that the NeoMed Dual Lumen Umbilical Catheter performs its intended use and is equivalent to the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   • Not applicable. The document refers to "bench testing" and "design verification performance test results," which implies laboratory testing of the physical device rather than a study using a test set of data. No information on sample size or data provenance is provided.
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. There is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   • Not applicable. There is no mention of a test set or 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 is not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   • Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   • Not applicable. Ground truth for an AI algorithm is not relevant to this submission. The "ground truth" equivalent for this device would be its functional performance in laboratory tests, confirming it meets design specifications and operates as intended, similar to the predicate.
8. The sample size for the training set
   • Not applicable. This is not an AI device, so there is no training set.
9. How the ground truth for the training set was established
   • Not applicable. This is not an AI device, so there is no training set or ground truth establishment relevant to AI.

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