Search Results

Olympus CD-6C-1 Coagulation Electrode has been designed to be used with the Olympus BF-240 Bronchovideoscopes for electrosurgical cauterization or hemostasis in upper airways and tracheobronchial tree.

Olympus CD-6C-1 Coagulation Electrode.

I apologize, but the provided text from the 510(k) summary for the Olympus CD-6C-1 Coagulation Electrode does not contain the information needed to answer your request about acceptance criteria and a study demonstrating device performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of the device's technical performance against specific acceptance criteria.

Here's what the document does provide:

• Device Name: Olympus CD-6C-1 Coagulation Electrode
• Intended Use: For electrosurgical cauterization or hemostasis in upper airways and tracheobronchial tree when used with the Olympus BF-240 Bronchovideoscopes.
• Classification: Class II, Endoscopic Coagulation Electrode and Accessories (21 CFR 876.4300)
• Predicate Devices: Olympus CD-1L/U Coagulation Electrode (Preamendment) and Olympus KD Series Sphinctertomes (K955247)
• Regulatory Determination: Substantially Equivalent

It does not include any sections describing:

• Specific acceptance criteria for performance metrics (e.g., coagulation time, temperature thresholds, tissue effect size).
• Details of a study conducted to test these criteria.
• Sample sizes for test sets or training sets.
• Data provenance, expert qualifications, or adjudication methods for ground truth because these are typically found in detailed performance studies, not in a 510(k) summary emphasizing substantial equivalence.
• Any mention of AI, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device