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The MSP/MK Blade (#507-0028) is designed as a replacement blade for the Chiron Hansatome #507-0036-01 microkeratome for lamellar resection of the cornea.

The microkeratome blades are manufactured either with a prefixed plastic post or have a slot/holes in the blade. The plastic post fits into a slot within the microkeratome instrument and the slot/holes in the blade are used to affix the blades to a stainless steel post on the microkeratome. The steel used for the blade in either configuration is the same, as well as the packaging and sterilization method. The blades are designed to be used in pre-existing, on the market, microkeratomes that presently use comparable disposable microkeratome blades. The microkeratome blades are single-use disposable. The blades are packaged in a plastic clamshell case and the case is packaged in a tyvek pouch. The blades are provided sterile.

This document, K993122, is a 510(k) submission for disposable microkeratome blades. It focuses primarily on demonstrating substantial equivalence to existing, legally marketed devices rather than presenting a performance study with specific acceptance criteria and detailed study results for the device itself.

Therefore, many of the requested elements for a performance study are not explicitly present in the provided text. The submission relies on a descriptive comparison and design/function similarity to predicate devices.

Here's a breakdown of the information available and what is not provided:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document does not describe a performance study with a test set of samples. The determination of substantial equivalence is based on a descriptive comparison to predicate devices, not a new performance study on a specific number of blades.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. No experts were used to establish ground truth for a test set, as no such test set or study is described in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This device is a surgical blade, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No. This device is a physical surgical blade, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided. No ground truth was established for a performance study. The basis for approval is substantial equivalence to legally marketed predicate devices, which means their established safety and effectiveness serve as the "ground truth" for the new device's claim.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable/Not provided. This is not an AI/ML device.

Summary of what the document does provide:

The document serves as a premarket notification (510(k)) to the FDA, asserting that the new disposable microkeratome blades are "substantially equivalent" to predicate devices already on the market. This type of submission relies on demonstrating that the new device has "the same intended use as the predicate device" and "the same technological characteristics as the predicate device," or "different technological characteristics than the predicate device" but that "the new device does not raise different questions of safety and effectiveness than the predicate device" and "the new device is as safe and effective as the predicate device."

In this case, the manufacturer primarily argues for same intended use (lamellar resection of the cornea using microkeratomes) and same technological characteristics (surgical grade stainless steel, similar design elements for compatibility with existing microkeratomes, similar packaging, and gamma radiation sterilization). The FDA's letter of "substantial equivalence" affirms this.

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