FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided text is a set of FDA correspondence regarding the 510(k) premarket notification for the Kowa Automated Tonometer KT-500. This document primarily focuses on regulatory approval based on substantial equivalence to a legally marketed predicate device.

Crucially, this document does NOT contain information about specific acceptance criteria for device performance, a study proving those criteria were met, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device meeting the same indications for use and having similar technological characteristics to a device already on the market. It does not provide details of a clinical study or performance data from the manufacturer's submission to demonstrate specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information you've outlined, as it is not present in the provided text.

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K Number

K961090

Device Name

AUTOMATIC VISUAL FIELD PLOTTER AP-125

Manufacturer

KOWA OPTIMED, INC.

Date Cleared

1996-06-17

(90 days)