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The Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged, and as part of a sterile kit.

The Plastic LOR syringe is a piston syringe of three pieces. It consists of barrel, plunger and piston. The barrel is available with Luer slip, NRFit lock, NRFit Slip male connector. The Plastic LOR syringe is provided in combinations of four connectors and four syringe capacities (5ml, 7ml, 10ml, 20ml). The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile will be supplied to Anesthetic Conduction Kit manufacturers to be sterile and packaged into kit. The Plastic LOR syringe is a single use device which will be supplied as sterile individually packaged and the non-sterile bulk packed. The sterilized by Ethylene Oxide Gas to achieve a SAL of 10° and supplied sterility maintenance package which could maintain the sterility of the device during the s helf life of five years.

This document is a 510(k) Summary for a Plastic LOR Syringe. The purpose of this summary is to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from various ISO and ASTM standards for syringes, neuraxial, and Luer connectors, as well as biocompatibility and sterilization standards. The reported device performance indicates compliance with these standards.

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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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The Busse Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of resistance technique; it will be filled with air and/or saline during use. The Busse Plastic LOR syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged and as part of a sterile kit.

The LOR plastic syringe is a single use device which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The syringe will be available in luer lock and luer slip.

This document describes a 510(k) premarket notification for the Busse Plastic LOR Syringe. The information provided heavily emphasizes the device's substantial equivalence to a predicate device and safety testing of its materials, rather than detailed performance criteria or clinical study results in the context of typical AI/ML device evaluations.

Therefore, many of the requested categories for acceptance criteria and the study proving device meets acceptance criteria cannot be fully addressed in the way they would for an AI/ML or diagnostic device. I will extract what is available and note where information is absent or not applicable given the nature of the submission.

1. A table of acceptance criteria and the 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)

This information is not explicitly provided in the document. The testing mentioned (biocompatibility tests) are bench/laboratory tests, not clinical performance studies with patient 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 information is not applicable. The "ground truth" for this type of device (a mechanical/physical medical device) is based on its physical properties, material safety, and functional equivalence, not on expert interpretation of clinical data in the same way an AI/ML diagnostic device would be. The biocompatibility tests have established protocols and pass/fail criteria, likely interpreted by laboratory specialists.

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

Not applicable. This concept pertains to resolving discrepancies in expert interpretations for establishing ground truth in diagnostic studies, which is not relevant for this device's submission.

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 device, nor is it a diagnostic device that would typically undergo MRMC studies. The submission is for a physical medical device (syringe).

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for this device's submission is based on:

• Material Biocompatibility Standards: Compliance with established biological qualification safety tests (Kligman Maximization, Intracutaneous Injection, Systemic Injection, Rabbit Pyrogen, L929 Mem Elution Tests).
• Technological Equivalence: Direct comparison to a legally marketed predicate device (Loss of Resistance Syringe - K061737) to demonstrate similar design, materials, and functional characteristics.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device being a physical syringe. The submission relies on substantial equivalence and material safety testing.

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

Not applicable, as there is no training set. The "ground truth" for the device's suitability is established through adherence to recognized biocompatibility standards and demonstration of technological equivalence to a predicate device already on the market.

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