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The laser systems are intended for use in multispecialty applications, including dermatology and plastic surgery, discectorny, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology.

The fiber optic delivery systems are intended for use with any holmjum laser (with a compatible connector) for its cleared applications.

The OmniPulse and OmniPulse-MAX Holmium Lasers are medical grade, Class IV, pulsed, solidstate, Ho:YAG laser systems designed to deliver pulsed infrared laser energy with a wavelength of 2.1 micron and 350 microsecond pulse width. Menu-driven control options allow the user to select pulse repetition rate, output energy, and maximum lasing period.

The Proposed Laser System is a medical grade, Class IV, pulsed, solid-state Ho:YAG laser system designed to deliver pulsed infrared laser energy with a wavelength of 2.1 micron. The pulsewidth may either be 350 microseconds or variable up to a maximum of 350 microseconds, depending on the configuration of the laser. Menu-driven control options allow the user to select pulse repetition rate, output energy, pulsewidth (if variable), and lasing duration.

The proposed delivery systems are single use, contact or near-contact fiber optic energy delivery devices consisting of a flexible bundle of buffered optical fibers contained in a stainless steel shaft: the proximal end of the laser fiber optic incorporates either a custom or and SMA connector. These devices are shipping sterile/non-pyrogenic; from time-to-time they may be offered in nonsterile form in which case the user will be provided with sterilization instructions.

The provided text describes information about a medical device (laser system and fiber optic delivery devices) but it does not contain the specific details required to answer your request about acceptance criteria and a study proving those criteria are met, especially in the context of device performance metrics like sensitivity, specificity, accuracy, or a multi-reader, multi-case study.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance: The document primarily focuses on the technical specifications of the laser system (e.g., wavelength, power output, pulse width) and the delivery systems. It states that "The proposed delivery systems were subjected to a series of tests; these tests included sterilization, efficiency, performance and mechanical studies" and that they "exhibit acceptable performance and mechanical properties." However, it does not quantify specific acceptance criteria (e.g., "device must achieve X accuracy" or "Y sensitivity") nor does it report numerical device performance against such criteria.
• Sample Size and Data Provenance: Since no clinical or performance study with quantified results is presented, there's no sample size for a test set or information on data provenance.
• Experts and Adjudication: These details are only relevant if a clinical study involving expert interpretation of data was conducted, which is not the case here.
• MRMC Study: The document explicitly states, "No clinical tests were submitted in this 510(k)." Therefore, an MRMC study was not performed.
• Standalone Performance: While the "efficiency, performance and mechanical studies" might imply some form of standalone testing, the results are not detailed, and no specific performance metrics are provided.
• Type of Ground Truth: Without a clinical study, there is no explicit ground truth generation discussed. The "acceptable performance and mechanical properties" are likely based on engineering and laboratory tests against predefined specifications.
• Training Set Sample Size and Ground Truth: This information would only be relevant for machine learning or AI-driven devices, which is not what this submission describes.

In summary, the provided text is a 510(k) summary for a medical device (laser system and fiber optic delivery devices) that establishes substantial equivalence based on technological characteristics and non-clinical bench testing, not on clinical performance studies involving a test set, human readers, or patient outcomes.

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