Search Results

Clicky Cros™ is indicated for fluid flow control and for providing access port(s) for administration of solutions in a limited contact duration (24 hours or less). Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids.

Clicky Cross™ is indicated for fluid flow control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids. Yomura Clicky Cross™ is a new medical device using as flow control switch and is developed by Yomura Technologies Inc. Click-release process via one-handed operation Less leakage issue than currently commercial products Stopcock system for I.V. set and other application Suitable for all current pressure infusion system There are two types of fitting end (Barb /Luer) for normal I.V. infusion sets. In order to meet the requirement of I.V. infusion set, here we provide two different types of fitting end (Barb/Luer).

The provided FDA 510(k) summary for the Clicky Cross™ device details its substantial equivalence to a predicate device, the Safeport Manifold™ (K111016). It primarily focuses on demonstrating that the new device is as safe and effective as the predicate.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The document doesn't explicitly present a table of "acceptance criteria" in a typical quantitative format for algorithmic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating equivalence to a predicate device by meeting established performance and safety standards for medical devices of this type.

The reported device performance is indicated by its compliance with various ISO and ASTM standards relevant to infusion equipment and biocompatibility.

2. Sample size used for the test set and the data provenance:

The document does not specify a "test set" sample size in the context of an AI/ML algorithm. The performance testing refers to physical device testing according to established medical device standards. Therefore, there is no information about data provenance like country of origin or retrospective/prospective nature as this device is a physical medical device, not a software algorithm relying on clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The device is a physical medical instrument (stopcock) and its performance is evaluated against engineering, materials, and biological safety standards, not against "ground truth" established by clinical experts for a diagnostic or prognostic AI algorithm.

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

This is not applicable for a physical medical device being evaluated against engineering standards.

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:

This is not applicable. The Clicky Cross™ is a physical stopcock, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable as the device is not an algorithm.

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

The "ground truth" for the Clicky Cross™ device is defined by compliance with the referenced international and national standards (ISO, ASTM, USP) for medical devices of its type. This involves objective measurements of physical properties, material characteristics, and biological interactions, rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set:

This is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This is not applicable as the device is not an AI/ML algorithm.

Ask a specific question about this device