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The BMC Radio Frequency Perforation Generator; Model RFP-100-115 (For Domestic Use) and Model RFP-100-230 (For International Use) is indicated for use in general surgical procedures to cut and coagulate soft tissue.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device called the "BMC Radio Frequency Perforation Generator."

This letter grants market clearance based on substantial equivalence to a previously marketed device, not on specific acceptance criteria and performance data as might be found in a clinical trial report or a detailed justification for performance claims.

The document primarily states:

• The device name: BMC Radio Frequency Perforation Generator
• The FDA regulation number and name the device falls under.
• The FDA's determination of substantial equivalence.
• Indications for Use: "The BMC Radio Frequency Perforation Generator... is indicated for use in general surgical procedures to cut and coagulate soft tissue."

Therefore, I cannot extract the requested information about acceptance criteria, detailed study parameters, or performance results from this document.

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