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The coagulation of tubes, tissue coagulation and vascular coagulation, and to stop bleedings under endoscopic vision, including coagulation of the fallopian tube and the mesoalpinx for female sterilization.

The modular bipolar forcep set provides precise grasping and axial holding placement of the jaws, performs thorough hygiene, and site irrigation can be achieved without using additional instruments.

The provided document is a 510(k) summary for a medical device (Bipolar Forcep Set) seeking clearance for market. It does not describe AI device performance or a study proving an AI device meets acceptance criteria. Instead, it discusses the substantial equivalence of a new medical instrument to previously cleared predicate devices.

Therefore, I cannot extract the requested information about AI device acceptance criteria or performance from this document. The document primarily focuses on:

• Device Description: Bipolar forcep set (modular)
• Intended Use: Coagulation of tubes, tissue, and vasculature under endoscopic vision, including female sterilization.
• Technological Characteristics: Changes to insulation and addition of a cleaning port, but otherwise identical to a previously cleared device.
• Substantial Equivalence: Claimed to pre-enactment devices and K981321.
• Performance Data: No FDA performance standard, but tested against ANSV AAMI standard HF18 and IEC601-2-2, and biocompatibility tests. No clinical tests were performed.

All the requested fields regarding acceptance criteria and study details for an AI device are not applicable to the content provided.

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