(164 days)
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.
| Acceptance Criteria (Defined by ISO Standard) Type of Test | Requirement Defined in ISO 80369-6 | Test Method Defined in ISO 80369-20 | Reported Device Performance |
|---|---|---|---|
| Fluid leakage requirement | Clause 6.1.1 | Annex B | Conforms to applicable requirements |
| Leakage by pressure decay | Clause 6.1.2 | Annex B | Conforms to applicable requirements |
| Sub-atmospheric-pressure air leakage | Clause 6.2 | Annex D | Conforms to applicable requirements |
| Stress Cracking | Clause 6.3 | Annex E | Conforms to applicable requirements |
| Resistance to separation from axial load | Clause 6.4 | Annex F | Conforms to applicable requirements |
| Resistance to separation from unscrewing | Clause 6.5 | Annex G | Conforms to applicable requirements |
| Resistance to overriding | Clause 6.6 | Annex H | Conforms to applicable requirements |
| Additional Tests (Referenced Standards) | |||
| Leakage between piston and barrel | per ISO 595-2 | Conforms (implied by overall conclusion) | |
| Ink adhesion (permanence of marking) | per ISO 595-2 | Conforms (implied by overall conclusion) | |
| Identification of burrs, hooks, cracks, foreign contamination, missing components | per visual inspection | Conforms (implied by overall conclusion) | |
| Biocompatibility Compliance | ISO 10993 series, ASTM F756-17 | Considered adequate based on predicate device testing; tests repeated for updated standards |
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.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).