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The Arrow Epidural Needles are intended to inject local anesthetic into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.

The Arrow Epidural Needles are sterile, single use, disposable devices. They are used for the injection of anesthetic agents into a patient for regional anesthesia administration or to facilitate the placement of an epidural catheter for continuous infusion of local anesthetics.

The Arrow Epidural Needles consist of a plastic cannula hub with integrated wings that come with either Luer Connector and NRFit Connector, stainless steel cannula, and plastic stylet. The purpose of the stylet is to prevent tissue coring during needle insertion. The needle assembly is protected with a guard to prevent damage to the needle.

This document is an FDA 510(k) summary for the Arrow Epidural Needles. It does not present a study proving the device meets acceptance criteria in the way typically seen for AI/ML medical devices where performance metrics like sensitivity, specificity, or AUC are evaluated on a test set against a ground truth.

Instead, this document describes a traditional medical device submission where "acceptance criteria" are related to engineering performance standards, material characteristics, and biological safety, rather than diagnostic accuracy or clinical effectiveness in a comparative human-AI study.

Therefore, many of the requested fields are not applicable to the content provided. Here's a breakdown based on the provided document:

Device: Arrow Epidural Needles
Regulatory Class: Class II
Product Code: BSP (Anesthesia Conduction Needle)
K190026

1. Table of Acceptance Criteria and Reported Device Performance

The "Performance Data" section in the document outlines the tests performed to demonstrate substantial equivalence to a predicate device. These are engineering and biocompatibility tests, not clinical performance metrics for diagnostic accuracy.

Note: For traditional medical devices like this, the "acceptance criteria" are the successful completion of these standard tests, demonstrating that the device performs as intended and is safe and effective when compared to a legally marketed predicate device. The "reported device performance" is the successful completion of these tests, leading to the substantial equivalence determination. Specific numerical results are not typically summarized in the 510(k) summary unless critical for comparison.

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

• Sample Size: Not specified in the 510(k) summary. These tests are typically conducted on a sample number of manufactured devices according to the respective standards and internal quality control procedures.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are laboratory-based engineering and biological evaluations of the physical device. The testing was conducted by or for Teleflex Medical.

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

• Not applicable. This is not an AI/ML device requiring clinical ground truth establishment by medical experts for diagnostic accuracy. The "ground truth" for these tests is defined by the passing criteria of the international and industry standards (e.g., ISO, BS, ASTM, AAMI).

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication" in the sense of resolving discrepancies between human readers or an algorithm. The tests are objective measurements against defined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. This is not an AI/ML device that assists human readers.

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

• Not applicable. This device is a physical epidural needle, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable in the AI/ML sense. The "ground truth" for the performance tests described are the established specifications and pass/fail criteria defined by the relevant international and industry standards (e.g., tensile strength, resistance to breakage, corrosion resistance, Luer/NRFit connector integrity, biocompatibility, sterility) these devices are required to meet.

8. The Sample Size for the Training Set

• Not applicable. This is a hardware medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. There is no training set for this type of device.

In conclusion, this FDA 510(k) summary is for a traditional medical device (an epidural needle) and demonstrates substantial equivalence based on engineering performance, material characteristics, and biocompatibility testing against international and industry standards, not on clinical performance or diagnostic accuracy evaluated with a clinical test set and human readers as would be typical for an AI/ML medical device.

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