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The Eclipse DermaFlex Cannula is intended to inject fluids intradermally.

The Eclipse DermaFlex Cannula is provided as a single-use, sterile device. It is comprised of a needle. hub and cap. This device comes in a variety of needle gauges and lengths. The Eclipse DermaFlex Cannula offers AN type and B Type. The AN type is a hypodermic single lumen needle intended to prepare the site for injection. The tip of this pilot needle is sharpened at one end, while the other end is joined to a hub. The B type has a metal tube with the tip, which is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end, the device is joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or secondary medication sets to prepare and administer fluids/ medications/ drugs to a patient.

The Eclipse DermaFlex Cannula is a hypodermic single lumen needle intended to inject fluids intradermally. The submission demonstrates substantial equivalence to predicate device MV INTRADERMIC NEEDLES; MAGIC NEEDLE (K110606) by M.V. S.R.L.

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

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

The document does not explicitly state acceptance criteria in a quantifiable manner for each test. Instead, it refers to performance testing conducted in accordance with various ISO and ASTM standards. The reported device performance is a general statement that the device "meets the established characteristics and performance requirements needed to perform its intended function." It also states, "Substantial equivalence is established as these are the same standards established for the predicate device as well. As the Eclipse meets the required criteria of the standards, its performance may be considered to support substantial equivalence."

Therefore, the table below reflects what can be inferred from the document:

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 does not provide details on the specific sample sizes used for each test or the data provenance (country of origin, retrospective/prospective). It only lists the standards followed for the tests.

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 to this type of device (hypodermic needle). The ground truth for performance testing of a medical device like this is established through adherence to recognized international and national standards, not by expert consensus on clinical findings.

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

This information is not applicable as the evaluation of this device is based on objective performance testing against established standards, not interpretation of data by multiple readers requiring 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

An MRMC comparative effectiveness study is not applicable to this device. This is a physical medical device (cannula/needle), not an AI-powered diagnostic or assistive tool.

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

A standalone algorithm performance study is not applicable as this is a physical medical device, not an algorithm or AI system.

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

The ground truth for this device's performance is based on established national and international standards for medical device manufacturing, sterility, biocompatibility, and functional performance (e.g., needle strength, connection integrity, color coding). These standards define objective, measurable parameters.

8. The sample size for the training set

This information is not applicable as this is a physical medical device and does not involve a training set for machine learning or AI.

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

This information is not applicable as there is no training set for this type of device.

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