Search Results

• Cutting
  Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Blepharoplasty,
• Blended Cutting and Coagulation
  Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps,
• Hemostasis
  Control of Bleeding, Epilation, Telangiectasia
• Fulguration
  Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
• Bipolar
  Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry), Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage

The @Wman Surgitron 120 IEC enhanced capability Electrosurgery Generator described herein is a compact source of high power RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. This display is interlocked with the controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are provided. It is designed to comply with international safety standards.

This document is a 510(k) Premarket Notification for the Ellman Surgitron 120 IEC electrosurgical generator. It describes the device, its intended uses, and compares it to predicate devices to establish substantial equivalence. It does not contain information about a study proving the device meets specific acceptance criteria in the manner an AI/ML device study would.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies in the context you've outlined (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance, training sets). This type of data is not present in the provided document, as it pertains to a different class of medical device and regulatory submission.

The document focuses on demonstrating substantial equivalence to existing devices, primarily through comparison of:

• Indications For Use: The new device shares the same indications as the predicate devices (Surgitron IEC II and ERBOTOM ICC 200). These include various cutting, blended cutting and coagulation, hemostasis, fulguration, and bipolar functions for general and plastic surgery use, specifically mentioning procedures like snoring treatment, palatal shrinkage, myringotomy, and a range of dermatological and other surgical applications.
• Technological Characteristics: The document compares features such as design specifications, output energy (120 Watt for the new device vs. 100W/200W for predicates), output waveforms (4.0 MHz Sin-wave CW, Fully Rectified, Partially Rectified, and 1.7 MHz for Fulgurating Spark-Gap for the new device vs. similar or different frequencies for predicates), standards met (UL2601 and IEC 601-1 601-2-2, BS15724:2.2), delivery system (Monopolar and Bipolar), biocompatibility, and sterilization methods. The document states that many of these are "Same As New Device" or "Electrodes identical to predicate device," indicating equivalence.

The regulatory process for this type of device (electrosurgical generator) primarily involves demonstrating safety and effectiveness based on established performance standards and comparison to legally marketed predicate devices, rather than a clinical study evaluating diagnostic accuracy or algorithmic performance with elaborate test sets and ground truth as would be seen for AI/ML devices.

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