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The Laserscope Microbeam IV Micromanipulator is intended to be used in conjunction with a microscope for all cleared Laserscope indications for the KTP/532 and KTP/YAG Surgical Laser Systems.

The Laserscope Microbeam IV is a micromanipulator that delivers KTP/532 laser energy to a very localized area. The Microbeam IV is used in conjunction with a microscope that allows the surgeon to accurately position the laser; the Microbeam IV can produce a spot size from 250 microns to 400 microns. The Microbeam IV system consists of an optical assembly which focuses the laser light from the fiber optic cable to the surgical site. The Microbeam IV delivers the laser energy in line with the viewing path. There are two focusing adjustments on the Microbeam IV; the fine focus and the rapid defocus. The fine focus adjustment is used to focus the laser beam at the tissue. The rapid defocus knob quickly increases the laser spot size at the tissue. The Microbeam IV is compatible with most microscopes and can be used with most objective lenses.

The provided text is a 510(k) summary for the Laserscope Microbeam IV Micromanipulator. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information cannot be extracted directly from this document.

Here's the breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in the document. The filing focuses on "substantial equivalence" to a predicate device rather than specific performance metrics against pre-defined acceptance criteria.
• Reported Device Performance: The document only states that "The Microbeam IV can produce a spot size from 250 microns to 400 microns." This is a descriptive feature, not a performance metric against a specific criterion.

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

• Not applicable. This document does not describe a clinical performance study with a test set. The submission is based on substantial equivalence to a predicate device.

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. No test set or ground truth establishment by experts is described.

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

• Not applicable. No test set or adjudication process 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 is not an AI-assisted device and no MRMC comparative effectiveness study is described. The device is a micromanipulator for a surgical laser system.

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

• Not applicable. This is not an algorithm-only device. It is a physical medical device (micromanipulator) used with a human surgeon.

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

• Not applicable. No ground truth is mentioned as there is no performance study described in the context of diagnostic accuracy or similar metrics requiring ground truth.

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

• Not applicable. There is no mention of a training set or ground truth for it.

In summary: The provided 510(k) filing for the Laserscope Microbeam IV Micromanipulator is a regulatory document focused on demonstrating "substantial equivalence" to an existing predicate device, not on presenting a clinical performance study with detailed acceptance criteria, test sets, or ground truth establishment. Therefore, most of the questions pertaining to performance studies and expert evaluation cannot be answered from this specific document.

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