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The 'Oligio X' is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue.

Oligio X is a radio frequency therapy system. The radio frequency output of the device is 6.78 MHz, and the maximum power is 200 W. Oligio X consists of a main body including touch LCD monitor, a RF handpiece, return pads, a return pad cable, non-sterile treatment tips, cooling fluids, footswitch and a power cable. Oligio X RF System delivers radio frequency energy for selective coagulation of tissue while conductively cooling the epidermis. Oligio X delivers energy form the disposable tip to the patient, and employs radio frequency turning to provide radio frequency energy across a range of impedances for delivery to the patient through the tip.

The provided text does not contain information about a study proving the device meets acceptance criteria in the context of a clinical performance study with human subjects, expert adjudication, or ground truth establishment as would be typical for an AI/software-as-a-medical-device (SaMD) submission.

Instead, the document is a 510(k) premarket notification for a physical medical device, the "Oligio X," which is a radio frequency therapy system for dermatologic and general surgical procedures. The substantial equivalence determination is based on comparisons to a predicate device and non-clinical testing, primarily focused on electrical safety, electromagnetic compatibility, software validation, and biocompatibility.

Specifically, the document states: "No clinical studies were considered necessary and performed." This indicates that for this particular device submission, a clinical performance study (which would typically involve the elements you've asked about, such as ground truth, experts, and human-in-the-loop performance) was not required by the FDA.

Therefore, I cannot populate the table or answer the specific questions related to a clinical study and AI performance, as that information is not present in the provided text.

However, I can extract the "performance testing" details that were reported from non-clinical bench tests:

Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Tests)

For the rest of your questions, based on the provided text:

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. No clinical test set or human data is mentioned. The "test set" for the reported performance was likely conducted on the device itself as part of bench testing.
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. No expert review or ground truth establishment for a test set (involving clinical data) was performed or mentioned.
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. This device is not an AI/SaMD product that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This device does not use a training set for machine learning.
9. How the ground truth for the training set was established: Not applicable.

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The 'Oligio X' is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue.

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This document is a 510(k) premarket notification acceptance letter for the device "Oligio X". It does not describe acceptance criteria for device performance, nor does it present a study proving the device meets performance criteria.

It confirms that the "Oligio X" device is substantially equivalent to a previously cleared predicate device ("Oligio" K221989) and outlines the regulatory requirements the device must meet.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size for a test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone algorithm-only performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The central point of this document is the FDA's determination of substantial equivalence, which is based on the device having the "same electrification, principle, method, indication for use, and same components" as the predicate device, with differences limited to the color of the main body, handpiece, handpiece tip, and the GUI (Graphical User Interface) of the device.

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