Search Results

Sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site. These accessories have applications in general endoscopy and laparoscopy procedures.

AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system.

Single-Use Hand-Control AEM Suction Irrigation Electrodes (DSIE) are electrosurgical accessories that

• . Conduct high-frequency monopolar electrosurgical energy from compatible electrosurgical generators (ESU)
• . Provide suction or irrigation

to a surgical site during laparoscopic and endoscopic procedures.

They combine the classic active electrode functions of cutting and coagulation by monopolar energy with the convenience of being able to provide suction and irrigation without having to swap instruments in and out of trocar, port, or cannula.

They are used during open, endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required.

{
  "acceptance_criteria_and_study": {
    "1. A table of acceptance criteria and the reported device performance": null,
    "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": null,
    "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": null,
    "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
    "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": null,
    "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": null,
    "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": null,
    "8. The sample size for the training set": null,
    "9. How the ground truth for the training set was established": null,
    "Study Summary": "The provided document is a 510(k) summary for a medical device (Single-Use Hand-Control AEM Suction Irrigation Electrodes). This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies typical for new algorithms or AI. \n\nThe conclusion states that the DSIE is 'substantially equivalent to its predicate devices in design and intended use'. It explicitly mentions that 'There are no significant differences between DSIE and the ConMed predicate in electrosurgery or suction/irrigation performance which would raise new issues of safety and effectiveness, performance, function or intended use of the device.' and 'There are no significant differences between DSIE and the Encision predicate in electrosurgery or AEM Monitoring performance which would raise new issues of safety and effectiveness, performance, function or intended use of the device.'\n\n**Based on the available information, the submission does not contain the details typically found in a study designed to prove device performance against a set of acceptance criteria, especially for AI/algorithm-driven devices.** Instead, it relies on demonstrating equivalence to existing, legally marketed predicate devices. Therefore, direct answers to the specific points about acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance are not present in this document."
  }
}

Ask a specific question about this device