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ClearCut™ S Incisional Instruments are sterile, single-use disposable devices intended for use during ophthalmic surgical procedures.

The ClearCut™ S family of incisional instruments are manual ophthalmic surgical instruments used by surgeons to create surgical incisions during ophthalmic surgical procedures. Incisional instruments incorporating sharps protection features provide injury prevention to those who come in contact with the device. The instruments are designed with an integral guard that can be activated to place the blade in a safe or exposed condition. The product is delivered to the user terminally sterilized by either gamma irradiation or ethylene oxide sterilization methods.

This 510(k) pertains to a manual ophthalmic surgical instrument (ClearCut™ S Incisional Instruments) that is exempt from direct performance comparison studies to establish substantial equivalence because it falls under a general control regulation (21 CFR 886.4350). Instead, the submission focuses on demonstrating compliance with safety and materials standards. Therefore, the requested information elements related to AI/algorithm performance and clinical studies are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not presented in a traditional tabular format with specific performance metrics for evaluation against a new AI algorithm. Instead, the submission focuses on meeting established standards and guidance documents related to medical devices with sharps injury prevention features and biocompatibility.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission does not involve a clinical test set for AI algorithm performance. The testing mentioned refers to mechanical and material compliance with standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not an AI-driven device requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable.

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.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" in this context refers to established engineering and medical device standards for sharps injury prevention and biocompatibility. The device's compliance with these standards serves as the "ground truth" for its safety and effectiveness for its intended use.

8. The sample size for the training set

Not applicable. This is not an AI algorithm.

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

Not applicable. This is not an AI algorithm.

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