Search Results

The NeedleVISE™ Large-Bore Sharps Securing Device is intended for use in various clinical procedures as a sharps securing device for contaminated needles that do not have integral engineered sharps safety systems.

The NeedleVISE™ Large-Bore Sharps Securing Device is a single patient procedure use, disposable device used for securing needles. The healthcare professional using only one hand can render the sharps harmless. The purpose of the NeedleVISE™ Large-Bore Sharps Securing Device is to provide a means to make contaminated sharps immediately unavailable for all instances in which introduction of contaminated sharps containers is not acceptable.

The provided text describes a 510(k) submission for the Atrion NeedleVISE™ Large-Bore Sharps Securing Device, focusing on establishing substantial equivalence to a predicate device. The information primarily concerns mechanical testing and an ease-of-use field trial rather than a complex AI-driven diagnostic or analytical device. As such, many of the requested criteria related to AI performance, expert review, and ground truth establishment for AI models are not directly applicable or explicitly stated in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "field trials designed to assess ease of use" and "Summary of Testing" for mechanical properties. However, it does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided. The "field trials" would likely have involved healthcare professionals, but their number, specific qualifications, or their role in establishing "ground truth" (beyond assessing ease of use) are not detailed. For mechanical tests, the ground truth would be objectively measured physical properties, not expert opinion.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Given the nature of the device (a mechanical sharps securing device), adjudication methods commonly used for subjective diagnostic images are not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

An MRMC study was not done as this is a mechanical medical device, not an AI-assisted diagnostic tool. Therefore, there is no information about the effect size of human readers improving with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study was Done

A standalone algorithm performance study was not done as this device is a mechanical product and does not involve any AI algorithms.

7. The Type of Ground Truth Used

For the mechanical tests (impact, puncture resistance, pull-out force), the ground truth would be objective physical measurements obtained through standardized testing procedures.

For the ease-of-use evaluation, the ground truth would be based on observational data and feedback from healthcare professionals during the field trials, likely assessing factors like intuitive design, efficient operation, and secure needle retention.

This is not expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.

8. The Sample Size for the Training Set

This question is not applicable as there is no mention of a training set for an AI model.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there is no mention of a training set for an AI model.

Ask a specific question about this device