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The MICROspecialties, keratome blades are designed to produce a corneal flap when used with the following Moria microkeratomes:

• MICROspecialties 200200 Blade for use on Moria LSK Microkeratome .
• MICROspecialties 600600 Blade for use on Moria CB Microkeratome

The disposable 200200 microkeratome blade is designed to be used with the Moria LSK microkeratome system. The disposable 600600 microkeratome blade is designed to be used with the Moria CB microkeratome system. Both of these blades are designed to produce a corneal flap. The blades are packaged in plastic cases to protect the cutting edge and the placed in a Tyvek/poly pouch. They are sold as ten blades per box or in larger quantities of thirty (three ten-packs). Labeling identifies each quantity per box. The blades are then gamma radiation sterilized.
The blades are made from medical grade stainless steel with a single cutting edge. They are assembled with their compatible head and driver systems.

The provided text describes a 510(k) summary for two styles of microkeratome blades, but it is not a study report that would include detailed acceptance criteria and performance data in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions a "nonclinical evaluation" and "design validation" but does not provide the specific quantitative details needed to fill out a table of acceptance criteria and reported device performance, nor does it detail the methodology of a formal study with the requested elements.

Therefore, I cannot generate the requested table and detailed study information. However, I can extract the available information regarding the evaluation performed:

Summary of Device Evaluation Information from the Document:

• Acceptance Criteria and Reported Device Performance: This information is not provided in a quantitative or systematic way in the document. The text generally states that "Engineering, manufacturing and inspection specifications were finalized based on this evaluation," and "The blades go through 100% inspection to insure that they meet the product specification and follow design controls of MICROspecialties." No specific numerical criteria or performance metrics are given.
• Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Independent physicians and clinics were used to evaluate the performance," but does not give a specific sample size for the test set or the country of origin. It appears to be a nonclinical evaluation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The document mentions "Independent physicians and clinics," but does not specify how many, their specialties, or their years of experience.
• Adjudication method: Not mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned or described.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (surgical blade), not an AI algorithm.
• The type of ground truth used: Not explicitly defined in terms of a formal ground truth process. The evaluation included "package handling, ease of use, performance on the respective Moria microkeratomes" and "appearance, compatibility with the Moria microkeratomes and performance within these systems." This suggests observation-based feedback and functional testing.
• The sample size for the training set: Not applicable and not mentioned. This is a medical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable and not mentioned.

Conclusion:

The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence. It does not contain the detailed, quantitative study data typically found in a scientific paper or a comprehensive test report that would describe explicit acceptance criteria, performance metrics, ground truth establishment, or statistical methods. It largely relies on a risk analysis, design validation, manufacturing controls, and qualitative user feedback to support its claims of safety and effectiveness relative to a predicate device.

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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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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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