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The Microspecialties, Inc., 300135, 300160 and 300200 keratome blades are designed for use with other manufacture's keratome. These blades are for use in the Insight Technologies Instruments, Model K-SERIES Keratome.

This summary of 510K safety and effectiveness information is being submitted for the MICROspecialties Disposable Keratome Blades with Holder, which an equivalence determination could be based. There are three blade styles as part of this submission, which have very slight differences in blade depth dimension. All of the blades are designed to fit Insight Technologies Instruments keratomes. The blades are manufactured out of the same materials, packaged and sterilized using the same methods. Blades without holders are assembled to keratome drivers with reusable holders. Blades with holders that are being submitted have the holder assembled to the blade thereby making the assembly of the keratome system easier and more convenient. The three (3) blades depths dimensions that control the depth of cut on the cornia are; 135 microns, 160 microns, and 200 microns. The holders of these blades will be color coded as a means of additional identification to the labeling. The keratome blades with holders are single-use, disposable. Both blades are packages in a foam case for protection and then pouched. Each blade will be sold in single units.

This 510(k) submission (K980570) for the MICROspecialties, Inc. Disposable Keratome Blades with Holder is a traditional medical device submission, not an AI/ML-driven device. Therefore, many of the typical acceptance criteria and study designs associated with AI/ML device performance (e.g., MRMC studies, standalone algorithm performance, AI vs. human performance metrics, training/test set details, ground truth establishment methods) are not applicable here.

This submission focuses on establishing substantial equivalence to existing predicate devices based on design, materials, manufacturing, and intended use, rather than demonstrating a specific performance metric beyond the predicates.

Here's an analysis based on the provided text, highlighting what is applicable and explaining why other sections related to AI/ML are not:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable in the context of an AI/ML device. This submission does not involve a "test set" of patient data for algorithm performance evaluation.
• The evaluation is based on comparison of product specifications, materials, manufacturing processes, sterilization, and intended use with legally marketed predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. There is no "ground truth" in the AI/ML sense, as there's no diagnostic or predictive output being evaluated against expert consensus or pathology.
• The "experts" involved would be regulatory bodies (FDA reviewers) assessing the provided documentation and comparing it to predicate devices and relevant standards.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication process as defined for AI/ML performance evaluation occurred.

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

• Not Applicable. This is not an AI-assisted device, so no MRMC study or AI improvement metrics were performed or are relevant.

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

• Not Applicable. This is a physical surgical blade, not an algorithm.

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

• Not Applicable. No explicit "ground truth" in the AI/ML sense is mentioned or required for this type of device submission. The primary "truth" the FDA assesses is whether the device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective. This is based on objective comparison of characteristics and adherence to standards.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" or "ground truth" in the AI/ML context.

Summary of "Study" and Evidence for Substantial Equivalence:

The "study" in this context is the 510(k) premarket notification process, where MICROspecialties, Inc. presented a detailed comparison of their Disposable Keratome Blades with Holder to existing predicate devices.

Evidence presented for substantial equivalence:

• Descriptive Comparison: Explicitly stating similarity in "design, construction, and function" to specific predicate devices (Howard Instruments, Inc. Cbalk-1000 LASIK Blade K972727 and Med-Logics, Inc. ML Microkeratome Blade K962661). The key difference (integrated holder) is identified and implied to not fundamentally alter the safety or effectiveness.
• Material Specification: Using 400 Series Stainless Steel, a common surgical material, implying biocompatibility and mechanical properties consistent with predicate devices.
• Sterilization Validation: Adherence to recognized international standards (ANSVAAMI/ISO 11135-1994) for ethylene oxide sterilization, demonstrating sterility assurance comparable to other medical devices.
• Performance Characteristics: Specification of blade depths (135, 160, 200 microns) which are directly related to the intended use of creating corneal flaps of specific thicknesses, consistent with the functionality of similar keratome blades.
• Intended Use Statement: Clear indication that the blades are for use with specific keratoome instruments (Insight Technologies Instruments, Model K-SERIES Keratome), aligning their application with that of predicate blades.

Conclusion from the FDA: The FDA's letter (K980510) indicates that based on the submitted information, the device was found to be substantially equivalent to devices marketed prior to May 28, 1976, or to lawfully reclassified devices. This finding signifies that the device meets the regulatory "acceptance criteria" for market entry in terms of safety and effectiveness being equivalent to already approved devices.

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