(99 days)
'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.
| Acceptance Criteria (Technical Specification) | Reported Device Performance ("The Oligio") | Predicate Device (Thermage FLX System) Performance | SE Decision (vs. Predicate) |
|---|---|---|---|
| Intended Use | Dermatologic and general surgical procedures for electrocoagulation and hemostasis of soft tissue. | Dermatologic and general surgical procedures for electrocoagulation and hemostasis. | Same |
| Principle/Method of Operation | Delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis; delivers energy from disposable tip to patient; employs RF tuning. | Delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis; delivers energy from disposable tip to patient; monitors skin contact; employs RF tuning. | Same |
| Output frequency | 6.78MHz ± 1% | 6.78MHz | Same |
| Max output power | 145 W | 400 W | Different (but covered by range, does not affect SE) |
| Mode of Operation | Manual or footswitch | Manual or footswitch | Same |
| Electrical Safety | Complies with IEC 60601-1:2005, IEC 60601-2-2:2017, IEC 60601-1-2:2014, IEC 61000-3-2:2018 | (Implied compliance for predicate) | Demonstrated compliance |
| Software Validation | Was designed and developed according to a software development process and was verified and validated. (Basic Documentation Level software) | (Implied compliance for predicate) | Demonstrated compliance |
| Biocompatibility (RF tip) | Polyethylene terephthalate, Intact Skin, Limited ( |
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.