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The catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

The catheter introducer system is a notched introducer needle with a vented fitting and a splittable sheath introducer to facilitate percutaneous placement of a peripherally inserted central catheter (PICC) or midline catheter. The notched needle and clear sheath allow for easy insertion and a quick visual indication (flashback) when the vessel is penetrated. The catheter introducer is available to introduce 26ga/1.9Fr catheter.

The provided text is a 510(k) summary for the FirstStic™ N Introducer. It describes the device, its intended use, and the tests performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific level of detail requested in your prompt regarding acceptance criteria and study particulars for a medical AI/ML device.

This document describes a catheter introducer, which is a physical medical device, not an AI/ML diagnostic or prognostic tool. Therefore, many of the requested categories (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set sample size, and ground truth for training set) are not applicable or the information is not provided in the context of this type of device submission.

Here's a breakdown of the available information in relation to your request, and where information is not applicable or not provided:

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

The document states: "A series of testing was conducted in accordance with protocols based on requirements outlined in the guidance and industry standards and the results were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, the specific numerical acceptance criteria and the reported performance values against those criteria are not detailed 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: Not specified. For physical device performance testing (e.g., crack force, penetration force), sample sizes are typically determined by statistical methods or industry standards but are not reported in this summary.
• Data Provenance: Not applicable in the context of device performance testing of a physical product. These are laboratory tests, not clinical or image-based data.

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. Ground truth, in the context of experts, usually refers to clinical diagnoses or annotations for AI/ML models. For a physical device, "ground truth" relates to the physical properties measured against engineering specifications, which do not typically involve expert clinical consensus in the same way.

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

Not applicable for physical device performance testing.

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 a physical introducer device, not an AI/ML system for diagnostic support.

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

Not applicable. This is a physical device.

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

For the performance tests, the "ground truth" would be established by engineering specifications and industry standards (e.g., a certain force measurement instrument reading being within a predefined range). For biocompatibility, it's compliance with ISO 10993-1.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

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

Not applicable.

Summary of what is provided about the study:

• Device: FirstStic™ N Introducer (a catheter introducer).
• Study Type: Performance and Biocompatibility testing to demonstrate substantial equivalence to predicate devices.
• Performance Tests Performed: Dimensional Analysis, Lie Distance, Needle Penetration Force, Transition Penetration Force, Sheath Crack Force, Sheath Peeling Force, Needle hub retention force, Sheath hub retention force, Visual confirmation of flashback, Simulated Use.
• Biocompatibility Tests Performed (per ISO 10993-1): Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Acute Systemic Toxicity/Material Mediated Pyrogen, Hemocompatibility (Hemolysis Direct and Indirect), Thrombogenicity, Complement Activation Assay (Direct Contact). An additional particulate analysis was also conducted.
• Conclusion: The tests demonstrated that the device meets acceptance criteria for substantial equivalence and did not raise new safety or performance questions.
• Standards/Guidance: Testing was conducted in accordance with protocols based on requirements outlined in guidance and industry standards.

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