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The PORTEX® Tuohy and Hustead Needles with NRFif™ connectors are intended to facilitate the placement of an epidural catheter and for the injection or infusion of regional anesthetics or narcotics.

The sterile, single use Tuohy and Hustead needles with NRFit™ connector are for insertion into the epidural space for either single shot doses of anesthetic or narcotics or as an introducer for epidural catheters or spinal needles. The Tuohy needles are marked at 10 mm graduations to enable the depth of needle insertion to be determined. The Tuohy needles are supplied with a removable wing which allow the needle to be used as a winged or non-winged needle. The stylet hub is color-coded for ease of identification. The intended target population is pediatrics and adults.

The provided text describes the non-clinical testing performed on the PORTEX® NRFit™ Epidural Needles to demonstrate their substantial equivalence to predicate devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each test. It broadly states that "All testing met pre-established specifications."

The data provenance is from non-clinical performance testing, meaning these are laboratory tests on the device itself, not clinical data from patients. There's no information about country of origin for the data or whether it's retrospective or prospective, as it's not clinical 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)

This section is not applicable. The "ground truth" in this context refers to established standards (e.g., ISO, ANSI/AAMI, USP) and the physical properties and performance of the device. There were no human experts establishing ground truth for a diagnostic outcome, as this is a device for fluid delivery and catheter placement, not a diagnostic imaging device.

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

This section is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed for ambiguous cases. These were non-clinical, objective tests against established 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 section is not applicable. This document describes the testing for an epidural needle, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This section is not applicable. This document describes the testing for a physical medical device (epidural needle), 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 testing was established by recognized international and national standards and test methods. These include:

• ISO 80369-6 (for connectors for neuraxial applications)
• ISO 9626-2016 (for stiffness and bending force of needles)
• PWI-10005073-Test Method for Needle Penetration Force
• ISO 11607 (for packaging)
• ISO 11135 (for sterilization)
• ISO 10993 series (for biocompatibility)
• ANSI/AAMI ST72 (for bacterial endotoxins)
• USP 788 (for particulate matter)

These standards define the acceptable performance parameters and methodologies for testing.

8. The sample size for the training set

This section is not applicable. This document describes the testing of a physical medical device, not a machine learning model, so there is no "training set."

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

This section is not applicable. As there is no training set for a machine learning model, the concept of establishing ground truth for it does not apply here.

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PORTEX® products and components with the NRFit™ Connector are intended for the injection or infusion of regional anesthetics or narcotics.

The PORTEX® LOR Syringe with NRFit™ Connector is intended for use with NRFit™ compatible components to verify needle tip placement in the epidural space by the Loss of Resistance technique using air or saline. The NRFit™ connector is designed to be used with regional anesthesia systems only.

The PORTEX® EpiFuse Catheter with NRFit™ Connector is intended for use with the catheter and compatible components for the injection or infusion of regional anesthetics or narcotics. The key is a tool for re-opening the catheter connector.

PORTEX® Epidural Flat Filter with NRFit™ Connector is designed for use when administering injections and/or infusions of regional anesthetics or narcotics to a patient via compatible system components. The NRFit™ Connector is designed to be used with regional anesthesia systems only.

The PORTEX® Filter Needle with NRFit™ Connector and PORTEX® Filter Straw with NRFit™ Connector are intended to draw up medication when using the PORTEX® LOR Syringe.

The PORTEX® Regional Anesthesia Portfolio with NRFit™, consisting of five (5) categories of product including PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector and the PORTEX® Filter Straw with NRFit™ Connector.

PORTEX® products and components with NRFit™ connector are intended for the injection or infusion of regional anesthetics or narcotics.

The NRFit ™ connector conform to ISO 80369-6. Small bore connector for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which are intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use.

The PORTEX® Regional Anesthesia Portfolio with NRFit™ connector are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.

This looks like a 510(k) summary for a medical device modification, specifically for the PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector, PORTEX® Filter Needle with NRFit™ Connector, and PORTEX® Filter Straw with NRFit™ Connector.

This document does not describe a study involving AI/ML performance, human readers, or expert adjudication for image analysis. Instead, it focuses on the non-clinical performance testing of a new medical device connector (NRFit™) to demonstrate its substantial equivalence to a predicate device. The acceptance criteria and the "study" that proves the device meets them are based on these non-clinical, bench-top tests, primarily conforming to existing ISO standards.

Therefore, for aspects related to AI/ML, human readers, expert ground truth, and training data, the response will state that this information is not applicable to this type of device submission.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a set of medical connectors, and the "performance" here relates to physical and biological safety and efficacy as defined by recognized standards.

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

This document does not specify a "test set" in the context of AI/ML or image data. The testing described is non-clinical (bench testing) for device components. The sample size for each specific non-clinical test (e.g., number of connectors tested for axial load) is not explicitly provided in this summary but would be detailed in the full test reports. Data provenance is not applicable here as it refers to physical and biological testing of manufactured products, not patient data.

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

Not applicable. This is a submission for physical medical devices and their connectors, not an AI/ML diagnostic or prognostic device that relies on expert interpretation of data for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here refers to physical product testing against international standards, not a diagnostic or classification task requiring expert adjudication.

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 not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective measurements and assessments against recognized international and national standards (e.g., ISO 80369-6, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788) for functional performance, sterility, packaging, and biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable. This is not an AI/ML algorithm.

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