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The AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.

The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The AEM Disposable Electrode and the AEM Disposable Handpiece connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The handpiece has foot switching and hand switching versions. The electrodes and handpieces are single use products, which are provided sterile. They are designed not to be re-sterilized.

The AEM Monitoring System, including the electrodes and handpieces, are designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode.

The electrodes, which consist of an insulated tip, shaft with locking knob, and AEM shield assembly, are available in various tip styles. The electrode has an inner insulation between the active conductor and shield tube, as well as a secondary outer insulation on the outside of the clectrode shaft. The electrodes snap into the handpiece.

One version of the handpiece provides switching for the Cut and Coag functions of the ESU. This version has an integral cord. The other version uses foot-switching provided with the electrosurgical generator. The foot-switching handpiece connects to either the existing reusable or disposable AEM Cord from Encision. The electrodes may be removed from the handpiece and replaced with another electrode within the sterile field.

The electrode can rotate freely or be locked in one of multiple orientations relative to the handpiece, as preferred by the surgeon.

The provided text is a 510(k) summary for the ENCISION AEM Disposable Electrodes and AEM Disposable Handpieces. It describes the device, its intended use, and technological characteristics, and declares substantial equivalence to predicate devices based on non-clinical performance testing.

However, the document does not contain the specific information typically found in a clinical study report regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement for a multi-reader or standalone study. The performance testing mentioned is "bench testing consisting of continuity and capacitance measurements, and compatibility testing."

Therefore, based only on the provided text, I cannot complete the requested tables and descriptions for clinical acceptance criteria and study details. The document is a regulatory submission focused on substantial equivalence to predicate devices through non-clinical testing rather than a detailed report of a clinical efficacy or performance study.

Here's what can be extracted and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

MISSING: The document does not specify quantitative acceptance criteria or detailed reported device performance metrics in the format of a clinical study. The testing was non-clinical.

2. Sample Size Used for the Test Set and Data Provenance

MISSING: No information is provided regarding a "test set" in the context of human data. The testing mentioned is "bench testing."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

MISSING: No experts for establishing ground truth are mentioned, as the testing was non-clinical bench testing, not a clinical study involving interpretation of data by experts.

4. Adjudication Method for the Test Set

MISSING: No adjudication method is mentioned, as there was no test set involving human data or expert interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

NO: The document does not describe a MRMC comparative effectiveness study. The testing was non-clinical to confirm safety and effectiveness for substantial equivalence.

6. Standalone Performance Study

NO: The document does not describe a standalone performance study in the context of an algorithm or AI. The performance verified was related to the device's AEM technology and delivery of electrosurgical energy through bench testing.

7. Type of Ground Truth Used

MISSING / NOT APPLICABLE: For bench testing, "ground truth" would relate to engineering specifications and measurements (e.g., continuity, capacitance values) rather than expert consensus, pathology, or outcomes data. These specific "ground truth" details are not provided.

8. Sample Size for the Training Set

MISSING / NOT APPLICABLE: This concept is not relevant to the non-clinical bench testing performed for this device. There is no mention of a "training set" as would be used for AI/ML development.

9. How the Ground Truth for the Training Set Was Established

MISSING / NOT APPLICABLE: Not relevant, as there is no training set mentioned.

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