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The KSEA Clearvision II is a lens irrigation system for cleaning the distal lens of the telescope and maintaining clear visualization without removing the scope from the surgical site during endoscopic neurosurgical procedures using an endonasal approach.

The KSEA Clearvision® II is a microprocessor-controlled pump device. The device provides irrigation to clean the objective lens of the scope and removes residual solution on the lens. It is used in conjunction with an irrigation sheath.

This document describes the 510(k) summary for the KSEA Clearvision® II Lens Irrigation System. Below is an analysis of its acceptance criteria and the study used for its approval, based on the provided text.

Based on the provided 510(k) summary, the KSEA Clearvision® II Lens Irrigation System is not a device typically evaluated with the types of performance studies listed in your request. This is a Class II device (neurological endoscope accessory) and its approval is based on demonstrating "substantial equivalence" to predicate devices, rather than meeting specific quantitative performance metrics like sensitivity, specificity, or accuracy derived from clinical studies with ground truth.

Therefore, many of the requested categories (sample size, data provenance, number of experts, adjudication, MRMC studies, standalone performance, type of ground truth, training set size, and ground truth establishment for training set) are not applicable to this type of regulatory submission and device.

The "acceptance criteria" for this device are primarily related to its functional and safety characteristics being equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• N/A. This device's approval is based on a demonstration of substantial equivalence to existing predicate devices, not on a clinical trial with a "test set" in the context of diagnostic or AI device performance. The submission relies on comparative analysis of specifications, intended use, and safety standards.

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

• N/A. As above, no "ground truth" test set was used for this type of device submission.

4. Adjudication Method for the Test Set:

• N/A. No test set or adjudication was 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:

• N/A. This device is an irrigation system, not an AI or diagnostic tool that would involve human readers or MRMC studies.

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

• N/A. This is a mechanical/electronic pump device; the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used:

• N/A. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior approval and marketing. The KSEA Clearvision® II is argued to be safe and effective because it shares fundamental technological and functional characteristics with these already-approved devices, and any minor differences do not raise new questions of safety or effectiveness.

8. The Sample Size for the Training Set:

• N/A. No "training set" is relevant for this type of device and submission.

9. How the Ground Truth for the Training Set was Established:

• N/A. No training set or ground truth for a training set was used.

Overall Study Described:

The "study" or evidence presented for the KSEA Clearvision® II Lens Irrigation System's approval is a substantive equivalence comparison with two predicate devices:

1. Xomed Endo-Scrub/Endo-Scrub 2 (K982594)
2. KSEA Clearvision® Lens Irrigation System (K013838)

The document highlights:

• Device Description: It's a microprocessor-controlled pump providing irrigation to clean the scope lens and remove residual solution.
• Technological Characteristics: Microprocessor control, fixed flow rate, adjustable reverse flow intervals, footswitch activation, self-diagnostic check, and monitoring of current/temperature.
• Summary of Substantial Equivalence: The submission asserts that the KSEA Clearvision® II is substantially equivalent because its basic features, design, and intended uses are similar to the predicate devices. Minor differences are argued not to raise new issues of safety and effectiveness, nor affect performance, function, or intended use.

The provided "Substantial Equivalence Table" is the core of the comparative analysis study. It meticulously lists characteristics of the proposed device alongside the predicate devices across various aspects (type of pump, function, controls, physical dimensions, safety features, and intended use), demonstrating where they are "Same," similar, or have minor differences that are deemed insignificant for safety and effectiveness. The FDA's 510(k) clearance letter (K072410) confirms that the agency agreed with this assessment of substantial equivalence.

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