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The Pilot Ultra Diode Laser is indicated for dentistry and oral soft tissue procedures of:

1. The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettatage, sulcular debridement, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue.
2. Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
3. Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

The Pilot Ultra 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 ± 20mm for a maximum of 3 watts of energy output. The laser energy is delivered to 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 delivery or pulse delivery options. The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.

This document (K142226) is a 510(k) Premarket Notification from the FDA regarding the "Pilot Ultra Diode Laser." It is a regulatory filing for a medical device and provides information on its substantial equivalence to a predicate device, intended use, and technical characteristics. However, it does not contain the kind of detailed study data (performance metrics, sample sizes, ground truth establishment methods, expert qualifications, etc.) that would be associated with a clinical trial or algorithm validation study. Therefore, I cannot extract the requested information.

The document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device (Precise SHP Diode Laser). This process primarily relies on comparing the new device's indications for use, technological characteristics, and performance features to those of the predicate device, rather than requiring extensive clinical trials with detailed performance metrics against acceptance criteria as might be expected for novel devices or AI/software as a medical device (SaMD).

The "Performance Data" section states: "Bench testing on an evaluation sample of the current device revealed that the device met the design criteria for essential performance, and satisfied the performance requirements indicated in 21 CFR 1010 and 21 CFR 1040. Device outputs were within performance requirements and all safety features and functions were operating correctly."

This statement confirms that some performance testing was done, but it does not provide quantitative results, define specific acceptance criteria beyond "met the design criteria for essential performance," or detail study methodologies as requested in the prompt. It's a high-level summary for a 510(k) submission, not a detailed study report.

Therefore, for the requested information regarding acceptance criteria and a study that proves the device meets them, this document does not contain the necessary details.

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