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The Portex® Lancet Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

The Portex® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

The PORTEX® Lancet Point Spinal Needle with NRFit™ connectors and PORTEX® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

The NRFit ™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is 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® NRFit™ Spinal Needles are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.

This Premarket Notification Traditional 510(k) includes various configurations of PORTEX® Lancet Point with NRFit TM connectors and PORTEX® Pencil Point Spinal with NRFit TM connectors.

The provided text details the non-clinical testing performed to demonstrate substantial equivalence for the Portex® Lancet Point Spinal Needles and Portex® Pencil Point Spinal Needles with NRFit™ connectors to their predicate devices. This is a premarket notification (510(k)) to the FDA, which focuses on demonstrating substantial equivalence rather than proving device efficacy from scratch.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for functional performance tests are primarily based on ISO 80369-6: Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications. While specific numerical acceptance criteria are not explicitly detailed in the summary, the document states that "All testing met pre-established specifications," implying adherence to the pass/fail criteria outlined in the referenced ISO standards.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests as summarized in "Table 2: Summary of Non-Clinical Testing" and described in Section 7 of the document. These tests evaluated the functional performance of the NRFit™ connectors, packaging integrity, sterilization effectiveness, and biocompatibility of the materials.

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

The document does not specify the exact sample sizes used for each of the non-clinical tests. It states that "various configurations" of the spinal needles were included. The data provenance is also not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given it's non-clinical testing (bench testing, lab tests), these details are typically less relevant than for clinical trials. The tests were performed in a controlled laboratory environment.

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

This information is not applicable to this type of submission. The ground truth for non-clinical performance and biocompatibility tests is established by adherence to recognized international and national standards (e.g., ISO, ANSI/AAMI, USP). There are no "experts" in the sense of clinicians establishing a "ground truth" on patient data for this kind of engineering and laboratory testing.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on objective measurements against pre-defined engineering and biological standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostic tools where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission concerns spinal needles, which are physical medical devices, not an AI or diagnostic algorithm, so an MRMC study is not relevant here.

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

This question is not applicable as the device is a physical medical instrument (spinal needle), not a software algorithm or an AI.

7. The Type of Ground Truth Used

For this submission, the "ground truth" is defined by established international and national standards (e.g., ISO 80369-6, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788). The device's performance is compared against the requirements and specifications outlined in these standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this device and its non-clinical testing. Training sets are used in machine learning and AI development, which is not relevant here.

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

This question is not applicable for the same reason as point 8.

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The DASH 6® NRFit Lock syringe and DASH® NRFit Slip Syringe are intended to be used with ISO 80369-6 NRFit neuraxial compliant devices for administration of neuraxial medication.

The DASH 6® NRFit Plastic LOR Device is intended to be used with ISO 80369-6 NRFit neuraxial compliant epidural needle for locating the epidural space.

Accessories:

DASH 6® Introducer Needle is intended to be used with ISO 80369-6 NRFit neuraxial compliant spinal needle for guiding the placement of the spinal needle into the arachnoid/epidural space.

DASH 6@ NRFit Syringe Cap is intended to be used with ISO 80369-6 NRFit neuraxial syringes for sealing the tip of the syringe.

DASH 6® NRFit Drawing Up Filter Straw are intended to be used with ISO 80369-6 NRFit neuraxial syringe for the drawing up of neuraxial medication and anesthetic.

DASH 6@ NRFit Blunt Drawing Up Needle (with and without filter) is intended to be used with ISO 80369-6 NRFit neuraxial syringe for the drawing up of neuraxial medication and anesthetic.

DASH 6® NRFit Bacterial Disc Filter is intended to be used with ISO 80369-6 NRFit neuraxial compliant devices to ensure aseptic administration of neuraxial medication and anesthetic.

DASH 6® NRFit Epidural Flat Filter is intended to be used with ISO 80369-6 NRFit neuraxial compliant devices to ensure aseptic administration of neuraxial medication and anesthetic.

DASH 6® NRFit Tuohy-Borst Adapter is intended to be used with a epidural catheter to provide an ISO 80369-6 NRFit compliant connection.

DASH 6® NRFit Syringe to Syringe Adapter is intended to be used with ISO 80369-6 NRFit neuraxial syringe to allow for mixing/transfering medication between two syringes.

DASH 6® NRFit Needle Hub Cap is intended for sealing the hub of an NRFit compliant needle.

DASH 6@ NRFit Epidural Catheter Feeder is intended to be used with ISO 80369-6 NRFit neuraxial compliant devices to assist the insertion of an epidural needle into the epidural space.

The DASH 6® NRFit Syringes (Lock and Slip Syringes) are Single Use, in-hospital devices. They are provided in sizes ranging from 1 mL to 60 mL. The devices incorporate a male NRFit connector for connection to a female NRFit port. The syringes are designed according to ISO 7886-1 & ISO 80369-6 standard. The syringes are used for neuraxial purposes (ISO 80369-6 NRFit connection) and functions exactly the same as any hypodermic syringes that are on the market (ISO 7886-1).

The syringes will be supplied as individually packed (sterile) and the bulk packed (Nonsterile). The Sterile packed items will be supplied directly to the user and the bulk packed will be supplied to Anesthetic Conduction Kit manufacturers to be packaged into kit.

The syringe packaging will indicate the volume/size, the connector type (Lock or Slip variants) that the syringe contains and the sterility/sterilization method the syringe have been processed.

The DASH 6 ° Plastic LOR devices are Single Use, in-hospital devices. It is provided with a 10 mL size/volume and incorporates a male ISO 80369-6 NRFit slip connector to connect to a female ISO 80369-6 NRFit Port.

The Plastic LOR devices are designed according to ISO 80369-6 standard. The syringes are used for neuraxial purposes (ISO 80369-6 NRFit connection) and functions exactly the same as the LOR devices on the market.

The device will be supplied as individually packed (sterile) and the bulk packed (Nonsterile). The Sterile packed items will be supplied directly to the user and the bulk packed will be supplied to Anesthetic Conduction Kit manufacturers to be packaged into kit.

The devices packaging will indicate the volume/size, the connector type (Slip) that the device contains and the sterility/sterilization method the device have been processed.

Accessories:
DASH 6® NRFit Syringe Caps: Single Use, in-hospital devices with a female ISO 80369-6 NRFit connector.
DASH 6® NRFit Drawing up Filter Straw: Single Use, in-hospital devices with a female ISO 80369-6 NRFit connector and filter.
DASH 6 ° NRFit Blunt Drawing up Needle (with and without filter): Single Use, in-hospital devices with a female ISO 80369-6 NRFit connector and blunt needle (with or without filter).
DASH 6® NRFit Bacterial Disc Filter: Single Use, in-hospital devices with male & female ISO 80369-6 NRFit connectors and a 0.22µm filter.
DASH 6® NRFit Epidural Flat Filter: Single Use, in-hospital devices with male & female ISO 80369-6 NRFit connectors and a 0.22um filter.
DASH 6 ° NRFit Tuohy Borst Adapter: Single Use, in-hospital devices with a female ISO 80369-6 NRFit connector and open catheter port.
DASH 6® NRFit Needle Hub Caps: Single Use, in-hospital devices with a Male ISO 80369-6 NRFit connector.
DASH 6® Epidural Catheter Feeder: Single Use, in-hospital devices with a compatible male ISO 80369-6 NRFit connector.

The provided text is a 510(k) Premarket Notification for the DASH 6® NRFit System, which includes syringes and various accessories. This document primarily focuses on demonstrating substantial equivalence to predicate devices through design verification and compliance with specific ISO standards. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets those criteria in the context of AI performance, MRMC studies, standalone algorithm performance, number of experts, or ground truth for AI model development.

However, I can extract the acceptance criteria and the type of study conducted to demonstrate the device's technical specifications and substantial equivalence, as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DASH 6® NRFit System are primarily defined by compliance with several ISO standards. The studies conducted were design verification tests demonstrating compliance with these standards.

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

The document describes bench testing for physical characteristics, dimensional verification, and biocompatibility, not a clinical study with a "test set" in the context of AI or diagnostic performance. Therefore, typical sample size or data provenance details for medical image analysis are not applicable. The testing was conducted to verify compliance with engineering standards (ISO standards). The document does not specify the exact number of units tested for each specific test, but mentions "All necessary bench testing was conducted."

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 is not applicable as the device is a physical medical device (syringes, needles, etc.) and its performance is evaluated against engineering and biological standards, not diagnostic interpretations from experts. Ground truth is established by objective measurements against specified engineering and material science criteria.

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

Not applicable. This device is not an AI diagnostic tool and does not involve human adjudication of results in the traditional sense of a clinical study or image interpretation.

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. The DASH 6® NRFit System is a medical device (syringes, needles, etc.) and not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is not an algorithm or AI system. Its performance is evaluated intrinsically based on its physical properties and adherence to manufacturing and safety standards.

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

The "ground truth" for this device's evaluation is primarily the specifications and requirements defined by international standards (e.g., ISO 80369-6, ISO 7886-1, ISO 10993 series) and the manufacturer's own design specifications. It is based on objective, quantifiable physical and chemical measurements (e.g., fluid leakage, dimensions, material compatibility).

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

Not applicable.

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