(32 days)
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)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| RF output frequency | 6.78MHz ± 1% |
| Max output power | 140 W |
| Handpiece vibration | Low (30dB), Medium (40dB), High (50dB) |
For the rest of your questions, based on the provided text:
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This device does not use a training set for machine learning.
- How the ground truth for the training set was established: Not applicable.
§ 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.