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The Pentax confocal laser system is a required accessory for legally marketed video endoscopes equipped with a confocal laser imaging module. The system is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by the endoscope. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

The Pentax Confocal Laser System (software controlled device) is intended for use as a required accessory with Pentax video endoscope system that are equipped with confocal imaging module. The confocal laser system includes a laser light source, system computer. A video endoscope equipped with a confocal imaging module is connected to a conventional video endoscope system that will present the video endoscopic image. The endoscope is connected to the confocal system laser light source. The endoscope confocal imaging module contains an optical fiber that transmits laser light to, and receives return light from, the subject tissue. The confocal laser system contains a laser light source which produces visible laser light and contains signal detection circuitry to transmit/ receive the light signals the endoscope confocal imaging module. The detected signal is sent to the system computer processes the confocal image information for display on the system monitor, controls the laser light source, and acts as an image storage device for still frame images.

The provided text describes the Pentax Confocal Laser System and its 510(k) submission, not a study involving acceptance criteria and device performance data. Therefore, I cannot extract the requested information.

The document states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This explicitly indicates that no performance study was conducted to establish acceptance criteria or demonstrate device performance as per your request.

The information provided only covers:

• Submitting company and device name
• Classification and predicate device information
• Device description
• Intended use
• A letter from the FDA indicating substantial equivalence based on the provided information, but explicitly stating it was not based on clinical performance data.

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