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The MESORAM® Hypodermic Needles are intended to inject fluids intradermally.

MESORAM hypodermic needles are single lumen hypodermic needles that will inject fluids into the intradermal space. The device consists of an AISI 304 stainless steel tube that is sharpened at one end, with the other end joined to a female connector (luer) designed to mate with a male connector.

MESORAM hypodermic needles are available in gauges 27 G, 30 G, 32 G, and 33 G, with varying needle lengths and outer diameters. The needles feature a protective tip cover which is formed of rigid polypropylene.

The provided text is a 510(k) Summary for the MESORAM® Hypodermic Needles. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

However, the information required to answer your specific questions, particularly regarding acceptance criteria for an AI/ML device and the detailed study proving it meets these criteria (such as sample size for test sets, expert adjudication methods, MRMC studies, or specific performance metrics like sensitivity/specificity), is not present in this document.

This document is for a physical medical device (hypodermic needles), not an AI/ML software device. The "acceptance criteria" discussed here refer to the performance of the physical needle against engineering standards (e.g., ISO standards for needle tubing, luer taper, and sterility), and biocompatibility testing, not AI model performance.

Therefore, I cannot provide answers to questions 1-9 as they pertain to the evaluation of an AI/ML device, which this submission does not describe. The document explicitly states: "No clinical data were required for this submission," meaning there was no large-scale study with human readers or AI involved to assess diagnostic accuracy or similar metrics.

If you have a document describing an AI/ML device submission, I would be happy to analyze it for the requested information.

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