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The bifurcated allergy skin testing needle is indicated for in-vivo diagnostic skin testing using the puncture technique.

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This document is a 510(k) premarket notification letter from the FDA regarding a Bifurcated Allergy Skin Testing Needle. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for a typical AI/software device.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance. This type of clearance generally relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different characteristics that do not raise new questions of safety and effectiveness. It does not involve a multi-reader multi-case study, standalone algorithm performance, or detailed ground truth establishment as would be seen for more complex AI-driven medical devices.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria in the context of an AI-driven device.

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The bifurcated vaccinating needle is indicated for use in administering vaccine by the scarification method.

Bifurcated Vaccinating Needle

The provided text is an FDA 510(k) clearance letter for a "Bifurcated Vaccinating Needle." This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications that you've requested.

The letter explicitly 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..."

This means the device was cleared because it was found to be "substantially equivalent" to an existing, legally marketed device, not because it underwent a new clinical trial or performance study against specific acceptance criteria. The FDA's 510(k) pathway often relies on demonstrating equivalence rather than requiring a full de novo study with novel acceptance criteria and detailed performance reporting.

Therefore, I cannot extract the requested information from the provided text.

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