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The devices are intended to cut and or coagulate (soft) biological tissue during surgical procedures.

The Soring GmbH MBC™ Series is a monopolar and bi-polar RF surgical device for cutting and coagulation. RF Surgery is the use of high frequency alternating electrical current (frequency higher then 300 kHz) with the purpose of alteration or destruction of cells and for cutting tissue. The Soring GmbH MBC™ Series is used for tissue removal and cauterization in connection with mechanical operation techniques. The tissue cauterization and cutting effects are accomplished by a combination of heating through the electrical resistance offered by the biological tissue and through the heating of the electrode. Heat production is mainly a result of the fact that biological tissue acts as an electrical resistor for frequencies normally used during RF surgery and that as an electrical resistor biological tissue heats up when electric currents flow through. The amount of heat developed is therefore dependent on the current and the resistance of the conductor (the biological tissue) put up by the patient. From an electrical point of view, the patient is the conductor. As a result, in a closed current loop of metallic conductors and biological tissue of equal cross sectional area the biological tissue heats up significantly more. As can be seen in the table below, different biological tissue types offer a wide range of electrical resistance and thus are affected differently by the applied RF signal. The Soring GmbH MBC™ Series internal circuitry automatically senses the resistivity and adjusts the RF signal accordingly for the best results.

This 510(k) summary describes an electrosurgical device, not an AI/ML powered medical device. Therefore, much of the requested information (e.g., sample sizes for training/test sets, ground truth establishment methods, expert qualifications, MRMC studies) is not applicable to this submission.

However, I can extract the acceptance criteria and the stated "performance data" as presented for this type of medical device submission.

Acceptance Criteria and Reported Device Performance

Note: This submission focuses on compliance with established electrical safety and electromagnetic compatibility standards, which are germane to electrosurgical devices. There are no performance metrics related to diagnostic accuracy, sensitivity, specificity, or other measures typically associated with AI/ML driven devices.

Non-Applicable Information for this Device (Electrosurgical Device)

The following information is not present or not relevant to this 510(k) submission for an electrosurgical device, as it pertains to AI/ML powered medical devices:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This device is not AI/ML based.
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): Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. There is no AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance is adherence to electrical and safety standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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