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

'The Oligio' is a radio frequency therapy system. The radio frequency output of the device is 6.78 MHz, and the maximum power is 145 W. "The Oligio" consists of a main body including touch LCD monitor, a RF handpiece, return pad cable, non-sterile treatment tips, cooling gas, coupling fluids and a power cable.

'The Oligio' RF System delivers radio frequency energy for selective coagulation of tissue while conductively cooling the epidermis. "The Oligio' 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 is a 510(k) Summary for a medical device called "The Oligio" by WON TECH Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device (Thermage FLX System) for regulatory clearance, rather than presenting a detailed clinical study for performance evaluation against specific acceptance criteria for AI or diagnostic accuracy.

Therefore, many of the requested items related to AI/algorithm performance, multi-reader multi-case studies, ground truth establishment for a training set, and detailed clinical study results cannot be extracted from this document because the device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic tool, and the submission explicitly states that no clinical studies were considered necessary and performed.

However, I can provide information based on the product's regulatory submission and its comparison to a predicate device.

Here's a breakdown of the information that can and cannot be extracted:

Acceptance Criteria and Device Performance (Based on Technical Specifications and Equivalence Claim):

The "acceptance criteria" here are not diagnostic accuracy metrics, but rather technical specifications that "The Oligio" device had to meet to demonstrate substantial equivalence to its predicate device. The performance is reported in comparison to the predicate.

Information NOT available in the provided text, as this is a regulatory submission for a non-AI electrosurgical device that did not require clinical trials:

2. Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set data is provided. Non-clinical bench tests were performed to verify electrical safety, software, and biocompatibility, but these are not diagnostic test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic test set or ground truth established by experts is 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 is not an AI-assisted device. The document explicitly states: "No clinical studies were considered necessary and performed."
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. The "ground truth" for this medical device's clearance is its technical compliance with standards and its substantial equivalence to a legally marketed predicate device based on similar intended use and technological characteristics, as demonstrated through non-clinical bench testing.
8. The sample size for the training set: Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Summary of Study (Based on Regulatory Submission):

The "study" described is a regulatory submission to the FDA (510(k) premarket notification) to demonstrate substantial equivalence of "The Oligio" device to a predicate device (Thermage FLX System), rather than a clinical trial proving diagnostic accuracy or human performance improvement.

• Objective: To demonstrate that "The Oligio" is substantially equivalent to a legally marketed predicate device (Thermage FLX System) for its stated indications for use (dermatologic and general surgical procedures for electrocoagulation and hemostasis of soft tissue).
• Methodology:
  • Comparative Analysis: A side-by-side comparison of "The Oligio" with the predicate device on various characteristics including intended use, principle of operation, output frequency, maximum output power, and mode of operation.
  • Non-Clinical Testing: Bench tests to ensure compliance with electrical safety standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 61000-3-2), software validation (Basic Documentation Level software), and biocompatibility of device components (RF tip material).
• Results: The manufacturer concluded that "The Oligio" is substantially equivalent to the predicate device, stating that "There are no significant differences between The Oligio and the predicate devices that would adversely affect the use of the product." The only difference noted (Maximum output power) was deemed not to affect substantial equivalence because the proposed device's power was within an acceptable range relative to the predicate.
• Clinical Studies: None were conducted, as stated in the document: "No clinical studies were considered necessary and performed." This is typical for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data and comparison to a known safe and effective predicate.

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