Search Results

The Omnitech Resectoscope Roller Device is indicated for ablation/ coagulation of the soft tissue and is intended for the use with compatible resectoscopes. The device will be sold as a sterile product to be used in the Urological and Gynecological fields.

Not Found

This document is a 510(k) clearance letter for a medical device called the "Omnitech Resectoscope Roller Electrode." It primarily grants marketing authorization and specifies the intended use of the device.

Based on the provided text, there is no information about acceptance criteria or a study proving that the device meets such criteria.

The document states:

• Device Name: Omnitech Resectoscope Roller Electrode
• K Number: K981463
• Indications For Use: "The Omnitech Resectoscope Roller Device is indicated for ablation/coagulation of the soft tissue and is intended for the use with compatible resectoscopes. The device will be sold as a sterile product to be used in the Urological and Gynecological fields."
• Regulatory Class: II (21 CFR 884.4160/Procode: 85 KNF)
• Clearance Date: July 17, 1998

The letter indicates that the device was found "substantially equivalent" to predicate devices marketed before May 28, 1976. This "substantial equivalence" determination is typically based on comparing the new device's technological characteristics, performance data (if applicable), and indications for use to a legally marketed predicate device. However, the details of any specific performance studies or acceptance criteria are not present in this document.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement because this information is not disclosed in the provided FDA 510(k) clearance letter. This type of document is a regulatory approval, not a detailed study report.

Ask a specific question about this device

Ask a specific question about this device