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The LED Visual Stimulator Goggles are intended to flash visible light into a patient's eyes. The LED Visual Stimulator Goggles are designed to be used in hospital and clinical settings by trained medical personnel.

LED Visual Stimulator Goggles are goggles that are used to stimulate the eyes to record an electrical response from the brain. LEDs inside the goggles flash light at the eye. An electrical signal from the brain in response to this stimulus is recorded by an evoked potential stimulator headbox.

The provided text is a 510(k) summary for the XLTEK LED Visual Stimulator Goggles. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information on acceptance criteria, specific study designs, or performance metrics in the way modern AI/software device submissions would.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
• Standalone performance results.
• Sample size for the training set or how its ground truth was established.

Reasoning for Absence of Information:

The document describes a medical device (LED Visual Stimulator Goggles) by XLTEK, which was cleared in 2001. This device is a hardware accessory used for stimulating the eyes to record electrical responses from the brain.

The core of the submission (as evidenced by sections E and D of the 510(k) summary) is to demonstrate substantial equivalence to a predicate device, the Grass-Telefactor LED Goggles. The predicate device was "grandfathered" into being a medical device prior to the 1976 Medical Device Amendment, meaning it did not have an FDA 510(k) or PMA listing itself.

For devices demonstrating substantial equivalence to a pre-amendment device, the regulatory pathway generally does not involve extensive clinical trials or performance studies with acceptance criteria as would be required for a novel device or a software/AI device. The focus is on showing that the new device has the same intended use, technological characteristics, and safety/effectiveness profiles as the grandfathered predicate.

The document states: "When used as an accessory with the Stim 1000 A/V [510(k) #K972157], the LED Visual Stimulator Goggles are substantially equivalent in terms of safety and effectiveness to the Grass-Telefactor LED Goggles manufactured by Astro-Med, Inc." This statement, along with the lack of detailed study descriptions, indicates that the approval was based on demonstrating equivalence, not on specific performance criteria derived from a controlled study with distinct test sets, expert ground truth, or adjudication as requested.

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