Search Results

The Model 2127-900 Series Endoscope Adapter is an accessory for the Clarus Medical Systems Model 2127 Endoscope. It is intended to be reusable. It is used to temporarily clamp or hold the endoscope when mounting to an airway catheter.

MOUNT AND 450 ENDOSCOPE ACCESSORY TEST PORARILY 00 USED AIRWAY CATHETER APPRODUATE TOGETHER ENDOSECHE ADD AN

The Model 2127-900 Series Endoscope Adapter is a machined or molded plastic piece used to hold an endoscope and airway catheter together. The endoscope adapter has a machined or molded tapered hub designed to fit firmly into the proximal end of various airway catheters. Additionally the endoscope adapter has a central hole designed to fit the outside diameter of the shaft on the appropriate legally marketed Clarus Model 2127 Endoscope.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the format you requested.

The document describes a 510(k) submission for the Clarus Model 2127-900 Series Endoscope Adapter and primarily focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The purpose of the device.
• Testing: It mentions "Biocompatibility testing" and "Physical testing" (disinfecting solution exposure, workmanship examination, dimensional measurements, material certification) as having been performed, and that the material "passed biocompatibility testing and is suitable for this application."
• Substantial Equivalence: It explains how the device is substantially equivalent to a predicate device.
• FDA Clearance Letter: The formal letter from the FDA stating clearance for marketing.

However, the text does not include:

• A table of specific acceptance criteria.
• Reported device performance against numerical thresholds.
• Details about a study design, sample sizes (for test or training sets), data provenance, expert qualifications, or adjudication methods for establishing ground truth.
• Any information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.

It merely states that certain tests were done and passed, which is a high-level summary rather than a detailed study report with specific acceptance criteria and performance data.

Ask a specific question about this device