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The indication for use of the Xenon Light Source PES 1 is to provide illumination for fiberoptic endoscopy to gastroenterological, urological, gynecological and ENT cavities, hollow organs and canals. The PES 1 replaces current equipment in this branch. Operation is only allowed in medically used rooms in which the electrical installation meets the safety requirements of national standards (e.g. VDE 0107). The device is not intended for direct application at the heard or central nerve system.

Xenon Light Source PES 1

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a Xenon Light Source PES-1, dated September 14, 1999. It states that the device is substantially equivalent to a predicate device and outlines regulatory information and responsibilities.

However, it does not include details about:

• Acceptance criteria table and reported device performance
• Sample sizes, data provenance for a test set
• Number of experts or their qualifications for ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used (pathology, outcomes, etc.)
• Training set sample size
• How ground truth for the training set was established

This document is solely a regulatory clearance and not a performance study report.

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The JENASCAN is intended for use as an accessory to surgical lasers, e.g., lasers used in dermatology and plastic surgery, for the ablation and vaporization of soft tissue under conditions of use as described in the manuals accompanying the lasers.

Please refer to the application, operator's, or user's manual(s) accompanying the laser for professional use instructions and detailed use information concerning the laser.

The Jenoptik JENASCAN is a microprocessor-controlled accessory for lasers used in dermatology and plastic surgery. The JENASCAN guides the laser energy over the skin during removal of soft tissue under the conditions of labeling as described in the laser operator's manual.

The provided document is a 510(k) summary for the JENOPTIK JENASCAN, a laser accessory. It explicitly states that no performance data were required or provided because the device is considered substantially equivalent to already legally marketed predicate devices. Therefore, the requested information regarding acceptance criteria, study details, and performance metrics cannot be extracted from this document.

The relevant section from the document states:

"Performance Data: None. The specifications and intended uses of the Jenoptik JENASCAN are the same or very similar to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."

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LOS is designed for the standard endoscope use in General Surgery, especially for diagnostic in the ENT field.

Standard Endoscope

The provided text is a 510(k) premarket notification letter from the FDA for a Standard Endoscope, and does not contain information about acceptance criteria, device performance, ground truth, or study details. It is a regulatory approval document confirming substantial equivalence to a predicate device. Therefore, I cannot extract the requested information from this document.

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Ask a specific question about this device

Ask a specific question about this device