Search Results

The Confocal Endoscopic Imaging System (CEIS) is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by legally marketed video endoscopes (equipped with a confocal laser imaging module), during endoscopic medical examination procedures. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

The Optiscan Confocal Endoscopic Imaging System (CEIS) is a software controlled device which is intended for use as a required accessory with a legally marketed and compatible video endoscope system that is equipped with confocal imaging module.

The Confocal Endomicroscopy Imaging System (CEIS) consists of three main units.

• The Control Unit (CEIS-CU) together with its monitor, keyboard, and footswitch, 1. is a computer based unit which performs the instrument control, and image capture and processing functions of the CEIS.
• The Optical Unit (CEIS-OU) a specialised endomicroscope interface unit which 2. performs the laser illumination and fluorescence detection functions of the CEIS.
• 3. The Isolation Transformer.

A video endoscope equipped with a confocal imaging module is connected to the CEIS-OU. Under control by the endoscopist, the CEIS-OU transmits visible laser light into the connected endoscope. The endoscope transmits this light to and then subsequently receives return light signals from the subject tissue. The returned light is detected by the CEIS-OU and converted into an electrical signal. The detected signal is sent to the System Computer (CEIS-CU) which processes the confocal image information for display on the system monitor, and allows still images of the tissue to be captured and stored.

The provided document is a 510(k) summary for the Optiscan Confocal Endoscopic Imaging System (CEIS). It details the device's description, intended use, and comparison to predicate devices for substantial equivalence. However, it explicitly states:

"The submission for substantial equivalence was not based on an assessment of clinical performance data."

Therefore, the document does not contain information regarding:

• Acceptance criteria for device performance.
• A study that proves the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Expert involvement for ground truth establishment or adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used.

The 510(k) submission for the Optiscan CEIS focused on demonstrating substantial equivalence to a predicate device (Pentax Confocal Laser System, K042740) based on similar intended use, indications, and technological characteristics, rather than on clinical performance assessment.

Ask a specific question about this device