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The Laserscope Automatic Eve Protection Filter is intended to be used in coniunction with an endoscope or microscope for all cleared Laserscope indications for the Orion and Aura Surgical Laser Systems.

The Laserscope Automatic Eye Protection Filter (AEPF) is a mechanical shutter that moves protective filter(s) into the line of view before the laser beam is emitted from the laser aperture. The AEPF is automatically activated when the laser foot pedal is pressed. The AEPF provides the user with an unobstructed view of the target when the laser is not activated. The AEPF is connected to the laser by an electrical cable which interfaces with the main control board. The drive/control electronics are monitored by the laser system's microprocessor. The software default is to ask the user if they want to disable the Automatic Eye Protection Filter. In order to activate the laser beam, the user must attach the Automatic Eye Protection Filter or disable the feature through the laser's control panel if they do not plan to utilize the device.

This document is a 510(k) Summary of Safety and Effectiveness for a Laserscope Automatic Eye Protection Filter (AEPF). It describes a simple mechanical device designed to protect a user's eyes from a laser beam by moving a filter into the line of sight when the laser is activated.

Based on the provided text, there is no acceptance criteria or study that proves the device meets specific performance criteria in the way you've outlined for AI/ML devices.

Here's why and how the information relates to your request:

Analysis of the document against your requested criteria:

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

   • Not Applicable. The document does not describe performance metrics for the AEPF in terms of accuracy, sensitivity, specificity, or similar statistical measures. The device is a safety mechanism, not a diagnostic or therapeutic tool that would typically have such performance criteria. Its function is to physically block the laser when activated.
   • The document states that the AEPF "provides the user with an unobstructed view of the target when the laser is not activated" and "is automatically activated when the laser foot pedal is pressed." These are functional descriptions, not performance metrics derived from a study.

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

   • Not Applicable. There is no "test set" in the context of performance evaluation for this device. The document describes a comparison to a predicate device based on equivalency in design and function, not on a data-driven performance study.

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 ground truth establishment in this context.

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

   • Not Applicable. No test set or adjudication.

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/ML device, and no MRMC study was performed.

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

   • Not Applicable. This is a mechanical safety device, not an algorithm.

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

   • Not Applicable. No ground truth in the context of performance data. The "ground truth" for this device's safety and effectiveness essentially relies on its mechanical design, its connection to the laser's control system, and the fact that it is "substantially equivalent (identical)" to an already approved predicate device.

8. The sample size for the training set:

   • Not Applicable. Not an AI/ML device, no training set.

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

   • Not Applicable. Not an AI/ML device, no training set or ground truth in this context.

Key Information from the Document Relevant to Device Evaluation:

The primary evaluation strategy for this device is substantial equivalence to a predicate device, not a performance study as would be conducted for a diagnostic or AI-powered system.

• Predicate Device: The Laserscope Automatic Eye Protection Filter is stated to be "substantially equivalent (identical) to the Automatic Eye Protection Filter which is an integral part of the Laserscope 800 Series Surgical Laser System."
• Method of Equivalence: The document highlights equivalency in "indications for use, materials, method of operation and physical construction."
• Performance Standards: The document notes that the surgical lasers it's intended for (Laserscope Orion and Aura) conform to federal regulations (21 CFR 1040.10 and 1040.11), but explicitly states, "Laserscope is unaware of any specific standards for Automatic Eye Protection Filters." This reinforces that performance is evaluated against the predicate's known safety, rather than independent metrics.
• Safety Assurance: "Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale" is based on its substantial equivalence to the predicate.

In summary, this 510(k) submission relies on the established safety and function of a previously approved identical device embedded within an existing laser system, rather than presenting a novel performance study with specific acceptance criteria and detailed statistical results.

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