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The NAMIC RCS is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media and saline solutions during an angiographic procedure.

Piston Syringe

This application is for a medical device (NAMIC RCS, a piston syringe) and not an AI/ML device. Therefore, the requested information regarding acceptance criteria for AI/ML performance, study design with human readers, ground truth establishment, and training/test set details is not applicable. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data and material comparisons.

Here's an analysis based on the provided document, addressing the relevant sections:

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

The document does not explicitly state quantitative acceptance criteria in a tabled format for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through adherence to recognized standards and non-clinical testing.

Reported Device Performance (as described by the sponsor):
"The NAMIC RCS is substantially equivalent to the predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included the performance evaluation conducted in accordance with the following FDA guidance documents, international standards, and testing which included:

• FDA's "Guidance on the Content of Premarket Notification 510(k) Submissions for Piston Syringes dated April 1993"
• ISO 7886-1:1997 "Sterile Hypodermic Syringes for Single Use -- Part 1: Syringes for Manual Use"
• ISO 594-2:1998 "Conical Fittings 6% (Luer) Taper for Syringes, Needles, Certain Other Medical Equipment - Part 2: Lock Fittings"

The conclusion states: "The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent."

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

Not applicable. This is a non-clinical device submission. Testing would likely involve bench testing of physical samples, not clinical data sets.

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)

Not applicable. Ground truth for AI/ML algorithms is not relevant for this device. The evaluation is based on engineering and material standards.

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

Not applicable. This is not an AI/ML device, so no adjudication of expert opinions on a test set is relevant.

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/ML device, and no MRMC studies are relevant.

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

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

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

Not applicable. The "ground truth" for this device would be established by compliance with engineering standards and specifications, and potentially functional testing against established benchmarks for syringes (e.g., force to depress plunger, leak integrity, Luer taper dimensions).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, no training set for an AI/ML algorithm is involved.

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