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Artsana disposable sterile insulin syringes are intended for subcutaneous injection of insulin.

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The provided document is an FDA 510(k) clearance letter for the "Artsana Piston Syringes" and "Artsana Insulin Syringes." This type of document confirms that a device is substantially equivalent to a predicate device already on the market and does not contain detailed information about specific acceptance criteria or a study proving that the device meets such criteria.

The 510(k) clearance process is primarily focused on demonstrating substantial equivalence, not on extensive performance testing against predetermined acceptance criteria of a novel device. Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert involvement, and specific performance metrics is not available within this document.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the FDA's decision is based on comparing the Artsana syringes to existing, legally marketed piston syringes, rather than a de novo evaluation against a defined set of performance acceptance criteria and a specific study proving those criteria were met as one would find for a novel device.

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