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The Pilot Pro Diode Laser is indicated for the procedures of removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissue in the fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, dermatology, podiatry, plastic surgery, urology, and gynecology.

The Pilot Pro Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 5 watts of energy output. The laser energy is delivered to the surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous emission or pulse emission options. The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is removable from the optical fiber system for cleaning and sterilization in between uses. The activation of the working beam diodes is completed by use of a foot-actuated switch.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Pilot Pro Diode Laser. It explicitly states that the device is substantially equivalent to a legally marketed predicate device (DenLaser 800 Plus, K062619). The primary method used to demonstrate this substantial equivalence is via bench testing to confirm the device meets design criteria for essential performance and satisfies performance requirements indicated in 21 CFR 1010 and 21 CFR 1040.

Here's a breakdown of the requested information based on the provided text. It's important to note that since this is a 510(k) for substantial equivalence and not a de novo premarket approval, the level of detailed clinical study information (like MRMC studies, specific expert qualifications, or ground truth establishment methods for large datasets) is often less comprehensive or simply not required in the same way.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of specific, quantifiable acceptance criteria with corresponding performance data in the typical sense of a clinical trial. Instead, it relies on demonstrating equivalence to a predicate device and adherence to regulatory standards and design specifications.

2. Sample Size used for the test set and data provenance:

• Sample Size: The document mentions "an evaluation sample of the current device." It does not specify the exact number of devices tested. This implies a limited number of devices used for bench testing, sufficient to demonstrate compliance with design and regulatory requirements.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting. There is no information about country of origin of data or whether it was retrospective or prospective, as it pertains to device performance testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not applicable. The study described is bench testing of a laser device's physical performance and safety features, not a diagnostic or clinical study requiring expert-established ground truth on patient data.

4. Adjudication method for the test set:

Not applicable. This was bench testing, not a study requiring adjudication of expert interpretations.

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 document describes a laser surgical instrument, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

Not applicable. This is a hardware device (diode laser) and not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is based on:

• Engineering specifications and design criteria: The device was tested against its own design parameters for essential performance.
• Regulatory standards: It was evaluated against the requirements of 21 CFR 1010, 21 CFR 1040, IEC 60601 series, and IEC 60825-1.
• Predicate device characteristics: The predicate device's established performance and safety served as a key benchmark for substantial equivalence.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-driven device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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