(30 days)
The Pilot Elite Diode Laser is indicated for dentistry and oral soft tissue procedures of:
- The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue.
- 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;
- Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
The Pilot Elite 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 3 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 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.
I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text doesn't contain such information. It is a 510(k) summary for a medical device (Pilot Elite Diode Laser), which focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria and results against those criteria.
The document discusses:
- Intended Uses: For dentistry and oral soft tissue procedures, temporary pain relief, and teeth whitening.
- Technological Characteristics: Laser energy delivered via solid-state diodes at 810 ± 20nm, max 3 watts, optical fiber system, 630nm aiming beam, adjustable power, continuous/pulse delivery options.
- Substantial Equivalence: To the Pioneer Elite Diode Laser (K131059) based on identical indications for use, performance features (wavelength, power, energy type, controls, delivery method), disinfection/sterilization methods, control systems, safety features, and performance monitoring.
- Conformity to Standards: Compliance with 21 CFR 1040.10 and 1040.11 (with deviations per Laser Notice 50), and recognized standards IEC 60601-2-22 Ed. 2, IEC 60825-1 Ed. 1.2, IEC 60601-1: 2nd Ed., IEC 60601-1-2, and IEC 60601-1-4.
- Performance Data (Bench Testing): "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."
However, the document does NOT include:
- A table of specific acceptance criteria.
- Reported device performance against those specific criteria.
- Details on sample size, data provenance, expert qualifications, or adjudication methods for any test set.
- Information on MRMC studies or standalone algorithm performance, as this is a laser device, not an AI/ML device.
- Specific ground truth types or how ground truth was established for training, as this is not an AI/ML device.
- Training set sample size.
The performance data mentioned ("Bench testing on an evaluation sample... met the design criteria for essential performance") is a high-level statement to justify substantial equivalence, not a detailed study report with specific acceptance criteria and results.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.