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The ambIT™ Introducer products are intended allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle.

The ambIT Introducer product line is intended for use by a physician or by a trained individual under direct supervision of a physician.

The ambIT™ Introducer is intended for the percutaneous introduction of a catheter

1. A stainless steel shaft with a sharp tip.
   a. Stainless steel shafts with sharp tips (various configurations such as beveled or touhy) may or may not be solid (may be hollow).. The diameter of the stainless steel shaft ranges from 11 to 17 GA and the length is from 3.25 to 12 inches.
2. A plastic peelable sheath (split T-handle) on the outside of the stainless steel shaft and/or a plastic/metal inserts inside hollow stainless steel shafts.
   a. Introducers that have a plastic sheath will allow the catheter to be inserted after the stainless steel shaft has been withdrawn. The tips of the stainless steel shaft will be blunt or sharp.
   b. Introducers that do not have a plastic sheath will allow the catheter to be inserted through the stainless steel shaft, after the plastic/metal insert has been withdrawn.
   The ambiT Introducers may have a handle or luer hub connected to the stainless steel shaft.

The following are the configurations and names for the amblT Introducers:

1. amblT Introducer Sheath
   a. Sterile single use product
   b. Made for use with ambIT Tunneler (without sheath) reusable product.
2. amblT Introducer Needle
   a. Sterile single use product
   b. Stainless steel shaft with sharp tip and insert inside stainless steel shaft.

The provided document is a 510(k) summary for the ambIT Introducer, seeking substantial equivalence to a predicate device, the On-Q Introducer.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the ambIT Introducers meet the requirements of several FDA-recognized consensus standards. It also claims substantial equivalence to the predicate device based on material, intended use, and similar testing to applicable ISO standards. The "reported device performance" is implicitly that the device passed all applicable testing requirements of these standards.

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

The document does not specify the sample sizes used for the testing conducted against the ISO standards. It generally states that "The product passed all applicable testing requirements."

The data provenance is from testing conducted by Summit Medical Products, Inc. as part of their 510(k) submission. It refers to a "comparison of the proposed and predicate device is provided" in Section 2, but this detailed comparison is not fully contained within the provided excerpts regarding the actual results of the testing. The nature of these tests (e.g., bench testing, animal studies) suggests they are prospective in the sense that they were performed specifically for this submission. The origin of any specific data (e.g., patient data) if applicable for performance claims, is not mentioned, as this device primarily relies on engineering and biocompatibility standards.

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

This information is not applicable in the context of this 510(k) submission. The "ground truth" for this device revolves around meeting established engineering and biocompatibility standards (e.g., ISO standards) and demonstrating substantial equivalence to a legally marketed predicate device. The assessment relies on technical testing and regulatory review rather than expert consensus on diagnostic or clinical outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable. As mentioned above, the evaluation is based on objective testing against established standards, not on human interpretation or adjudication of outputs.

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 information is not applicable. This document describes a medical device (catheter introducer) for which an MRMC study for AI assistance would not be relevant. AI is not mentioned as part of the device's function.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. This device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on:

• Predetermined engineering and performance specifications defined by recognized international standards (ISO 594-2, ISO 10555-1).
• Biocompatibility requirements as outlined in ISO 10993-1.
• The characteristics and performance of a legally marketed predicate device (On-Q Introducer K063234) for demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML product. The submission refers to a comparison with a predicate device and testing against established standards, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for an AI/ML algorithm.

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