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The Artiglass NRFit tip Glass 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 as explained in standard textbooks. These syringes are not intended for injection or aspiration.

The Artiglass NRFit TM tip Glass Syringes provided not sterile with ISO 80369-6 (NRFit™) compliant fittings. They are available in 5mL and 10mL, lock and slip configurations and 5mL and 10mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a borosilicate neutral with a graduated scale in milliliters (mL), a borosilicate neutral glass plunger and a nickel-plated brass tip. The plunger rod is amber colored to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles.

This document is a 510(k) premarket notification for a medical device, the Artiglass NRFit™ Tip L.O.R. Glass Syringes. It is typically submitted to the FDA to demonstrate that a device is substantially equivalent to a predicate device already on the market. Such submissions generally focus on demonstrating equivalence through comparison of technological characteristics and performance testing based on established standards, rather than clinical trials with human subjects or complex AI model evaluation.

Therefore, the sections of your request related to AI model evaluation, multi-reader multi-case studies, expert consensus on ground truth, and separate training/test sets for AI are not applicable to this document. The document describes a physical medical device, not an AI/ML diagnostic or prognostic tool.

Here's an analysis of the provided text based on the elements that are applicable:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally defined by the relevant ISO standards. The document states that the testing "demonstrates the proposed devices conform to the applicable requirements" of these standards. While a detailed table with specific numerical results vs. criteria isn't provided, it indicates compliance.

2. Sample sizes used for the test set and the data provenance

The document does not specify exact sample sizes for each non-clinical test (e.g., how many syringes were tested for leakage). It mentions that "Connector testing performed on the proposed device," implying that a sample was used, but the specific number is not provided.

• Data Provenance: The tests are non-clinical, meaning they are performed in a lab setting on the manufactured device, not using patient data. The country of origin of the data is implicitly the location where Artiglass Srl conducts its manufacturing and testing, which is Italy. The data is prospective in the sense that the testing is performed on the newly manufactured device to demonstrate its performance.

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 physical device, and the "ground truth" for performance is established by objective measurements against engineering standards (ISO norms), not by expert interpretation of data like in an AI/ML context.

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

Not applicable, as no human experts are adjudicating "ground truth" in the context of device performance testing against objective 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

Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is defined by the requirements and specifications within established international standards (e.g., ISO 80369-6, ISO 80369-20, ISO 595-2, ISO 10993 series). The device's performance is measured against these objective, predefined engineering and biocompatibility criteria.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

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The Artiglass LOR Glass 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 as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.

Artiglass L.O.R. Glass Syringe is glass syringe similar to that of a standard piston syringe. It 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. The Artiglass L.O.R. Glass Syringe is provided not sterile, in bulk form to other manufacturers as part of an epidural insertion trays as a component to the epidural kit. The syringe may be sterilized before use and it can be re-sterilized via Autoclave. Artiglass L.O.R. Glass Syringe is intended to be used only by qualified personnel. This syringe is not intended for injection or aspiration. The Artiglass L.O.R. Glass Syringe is available in volume of 5ml and 10 ml.

The Artiglass L.O.R. Glass Syringe is a medical device designed to verify needle tip placement in the epidural space using the Loss of Resistance technique.

1. Acceptance Criteria and Reported Device Performance:

Study Details Proving Device Meets Acceptance Criteria:

The device's performance was evaluated through Design Verification tests, which included bench and animal testing. The study was designed to assess the safety and effectiveness of the Artiglass L.O.R. Glass Syringes for their stated indications for use.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly stated in the provided text. The document mentions "Design Verification tests" and "bench and animal testing" but does not quantify the sample sizes for these tests.
• Data Provenance: Not explicitly stated. The manufacturer is Artiglass S.r.l. in Italy, suggesting the study likely originated there, but this is not confirmed. The study appears to be prospective in nature, as it involved performing new tests ("Design Verification tests were performed").

3. Number of Experts and Qualifications:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The study discusses compliance with international standards (ISO), which implies review by qualified personnel, but individual expert qualifications are not detailed.

4. Adjudication Method:

• Adjudication Method: Not applicable or not specified. This type of device (syringe) undergoes compliance testing against technical standards and direct performance assessment rather than a human-driven subjective assessment requiring adjudication (like image interpretation).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No. This is not an AI-assisted diagnostic device, but rather a physical medical instrument. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.

6. Standalone Performance (Algorithm Only):

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm, so a standalone algorithm performance evaluation would not be relevant.

7. Type of Ground Truth Used:

• Type of Ground Truth: The ground truth for this device is based on compliance with established international standards (ISO standards) for syringes and medical equipment, as well as direct performance assessment through bench and animal testing to ensure the device functions as intended and safely. This is not a diagnostic device relying on expert consensus or pathology for ground truth.

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no "training set."

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

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