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The Epidural Anesthesia Needles are intended to be used for injection into the epidural space/or placing the enidural catheter into the epidural space.

The Spinal Anesthesia Needles are intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management.

The Combined Anesthesia Needles are intended for injection of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The administration of the spinal anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space.

The proposed device, Epidural Anesthesia Needles are available in a series combination of needle size and length. The needle tubing is stabilized during puncture with use of an inner stylet. The stylet is withdrawn after the epidural anesthesia needle its anatomical site for neuraxial anesthesia. Then an epidural catheter is introduced into epidural cavities for convenience of injecting anesthetic continuously.

The proposed device, Spinal Anesthesia Needles are available in a series combination of needle size and length. The spinal anesthesia needle has a tightly fitting removable stylet that completely occludes the lumen to avoid block. The stylet is withdrawn after the spinal anesthesia needle has penetrated into the subarachnoid space for injecting anesthetic. The needles are available in Sprotte and Quincke two type.

The proposed device, Combination Anesthesia Needle are instruments for a spinal (subarachnoid) injection of anesthetics, followed by the placement of an epidural catheter to allow modification of the spinal analgesia if necessary, or continuous infusion of local anesthetics into the epidural space for subsequent pain relief if required. The needles are a matched set. The epidural needle and the spinal needle are locked by conical fitting that enable the spinal needle to be locked into position once the dura has been pierced so that it is secured to the epidural needle to prevent accidental displacement.

Here's the information about the acceptance criteria and study as extracted from the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." However, specific sample sizes for these non-clinical tests are not provided in the given text. The data provenance is also not explicitly stated beyond referring to international and US standards. It can be inferred that these non-clinical tests were conducted in a laboratory setting. The study is retrospective in the sense that it relies on existing predicate devices for comparison and established standards, rather than new prospective human trials.

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

This information is not provided in the document. The study relies on compliance with recognized standards and non-clinical testing rather than expert-derived ground truth based on patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the study did not involve human interpretation of results requiring adjudication. It focused on objective performance against technical 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

No MRMC comparative effectiveness study was done. This document pertains to the clearance of medical needles, which are physical devices, not an AI or imaging diagnostic tool that would typically involve human readers.

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

This question is not applicable as the submission is for physical medical needles, not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests appears to be defined by:

• Compliance with established international and US standards (e.g., ISO, ASTM, USP).
• Comparison to predicate devices in terms of technical characteristics and performance (e.g., biocompatibility test results like "No Cytotoxicity").

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device requiring a training set.

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

This information is not applicable as this is not an AI/machine learning device.

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