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The Microspecialties, Inc., 500500 and 400400 keratome blades are designed for use with other manufacturer's keratome. The 500500 blade is for use in the Chiron Keratome while the 400400 blade is used in the S.C.M.D. Keratome.

The 500500 and the 400400, keratome blades are single-use, disposable. The 500500 blade is for use in the Chiron keratome while the 400400 blade is used in the S.C.M.D. unit. Both blades are packages in a plastic "clamshell" for protection and then double pouched. Each blade will be sold in single units.

The provided text is a 510(k) summary for Disposable Keratome Blades. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with acceptance criteria and results for the new device. Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from this document.

The document discusses the device's design, materials, sterilization, and intended use, and compares it descriptively to predicate devices. It does not contain data from an analytical or clinical performance study.

Here's why I cannot provide the requested information based on this document:

• No Acceptance Criteria or Performance Results: The document does not list any specific acceptance criteria (e.g., blade sharpness, cutting efficiency, durability) or present performance data against such criteria.
• No Performance Study: The document's purpose is to demonstrate substantial equivalence through descriptive comparison and shared characteristics with predicate devices, not by conducting independent performance testing detailed with sample size, ground truth, or expert adjudication.
• Focus on Equivalence, Not Independent Performance: The 510(k) process often relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device (K972727 and K962661 in this case), meaning it is as safe and effective. This typically involves comparing design, materials, sterilization, and intended use, and less often involves extensive de novo performance studies with quantitative acceptance criteria unless there are significant technological differences or new intended uses.

Therefore, the requested table and details about the study, sample sizes, ground truth, and expert involvement are not available in the provided text.

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