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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.

AEM instruments incorporate the use of AEM technology and are intended for use with the Encision AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor.

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 material of the molded tip insulation has been changed. 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 electrode shaft.

The electrodes snap into the handpiece. 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.

This document is a 510(k) summary for AEM Disposable Electrodes and AEM Disposable Handpieces. It primarily focuses on demonstrating substantial equivalence to a predicate device due to a change in the tip insulation material. Therefore, it does not describe a study proving the device meets acceptance criteria in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity or specificity.

Instead, the "acceptance criteria" here refer to the requirements for demonstrating the safety and effectiveness of the new material and the devices' continued substantial equivalence. The "study" refers to the non-clinical performance testing conducted to support these claims.

Here's a breakdown of the requested information based on the provided text, acknowledging that some fields may not be directly applicable to this type of submission which focuses on material change and substantial equivalence rather than novel device performance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified for the biocompatibility or sterilization validation testing. The document states "Suitability of the new material..." and "Sterilization Validation has been performed...", implying tests were conducted, but specific sample sizes are not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal or performed by a third-party lab as part of the manufacturer's regulatory submission process. It is non-clinical, likely laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This submission relies on standardized testing (ISO 10993-1, AAMI/ANSI/ISO 11737-1 and -2) and engineering assessments rather than expert-established ground truth in a clinical or diagnostic context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here.

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

• Not applicable. This is not an AI-enabled device and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm or AI device. The testing described is for the physical device components and materials.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the non-clinical testing comprises internationally recognized standards and specifications (ISO 10993-1 for biocompatibility, AAMI/ANSI/ISO 11737-1 and -2 for sterilization validation) which define acceptable parameters for these properties. The device's performance is compared against these predetermined standards.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not applicable. No training set is involved.

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