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Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, gentourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only). Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: orthopedics.

The Aurolance AM diode laser system consists of a unit, footswitch, power cord assembly, unit key, and protective eyewear. The Aurolance 980 diode laser system consists of a main unit, footswitch, power cord assembly, unit key and protective eyewear. The Aurolance 810 diode laser system consists of a unit, footswtich, power cord assembly, unit key and protective eyewear. The LaserPro D980 diode laser system consists of a main unit, footswtich, power cord assembly, unit key, and protective eyewear. The LaserPro D810 diode laser system consists of a main unit, footswitch, power cord assembly, unit key and protective eyewear.

A review of the provided PDF reveals that it describes the FDA's decision to clear several Diode Laser Systems for marketing based on their substantial equivalence to previously marketed predicate devices. It does not contain information about acceptance criteria, the specific studies performed, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance. The document focuses on regulatory approval rather than detailed performance evaluations of an AI/ML algorithm.

Therefore, I cannot provide the requested information because the provided text does not contain the details about acceptance criteria and studies for an AI/ML device. The document is an FDA 510(k) clearance letter for a physical medical device (Diode Laser System), not an AI/ML software device.

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The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization of tissue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905connector.

·Laser must operate at a wavelength between 532 and 1064 nm.

• Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode.

• · Laser must have a numerical aperture of 0.35 or less.
  · Laser must accept universal SMA-905 connector, SLT proprietary connector, or an appropriate adapter into its fiber launch connector.

Note: These Fiber Delivery Systems are cleared for the particular indications of the laser system to which they are connected.

During use these products are exposed to biohazardous substances such as blood and other bodily fluids. They should be disposed of per your facility's procedures for biohazardous waste.

The SLT select fiber delivery system and contact tips is the transmission path for 810mm, 980mm wavelength laser generator to the surgical site, with the optical fiber as the propagation medium, by transmitting the diseased area, to achieve the treatment of the disease.

The SLT select fiber delivery system and contact tips, except for the CFE series of needle-tip one-piece flexible fibers, are fitted with a metal connector at the metal connector is threaded to connect to the contact laser tread, The FEF series models can be used as non-contact lasers without a treatment head.

The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria. The document is a 510(k) premarket notification for a non-AI medical device (SLT Select Fiber Delivery System and Contact Tips).

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details for an AI device from the provided text.

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