(233 days)
The Unicorn+ RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The RF System is used for the relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.
Unicorn+ RF System is consist of a host, a trolley, a footswitch, a power cord, three kinds of handpieces and matched electrodes.
The provided document is a 510(k) summary for the Unicorn+ RF System. It details the device's substantial equivalence to predicate devices for electrocoagulation, hemostasis, and pain relief. However, the document does not contain information regarding the acceptance criteria for a study demonstrating device performance or a detailed study description with specific acceptance criteria and performance results.
The document mentions various tests conducted to support substantial equivalence, focusing on safety and technological characteristics rather than direct performance against specific therapeutic metrics with defined acceptance criteria.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study proving the device meets acceptance criteria, as this specific information is not present in the provided text.
Here's what I can extract based on the information available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document describes various validation tests for safety and technological characteristics, but it does not present specific acceptance criteria for clinical performance or a study that proves the device meets such criteria. For instance, it mentions "thermal damage tests which is compare with the predicate devices" and "performance test reports," but the actual acceptance criteria and results are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the document. The document states "No preclinical and clinical data was provided in this submission" under the "Ex Vivo testing" section.
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):
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
This information is not provided in the document. The Unicorn+ RF System is an electrosurgical device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the document. The device is an RF system, not an algorithm, so this question is not directly applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided in the document. The document mentions "Ex Vivo testing conducted on four types of tissue-Live, Kidney, Skin and Muscle under GLP Thermal testing," which implies some form of empirical measurement, but it doesn't describe how "ground truth" for therapeutic efficacy was established in a clinical context.
8. The sample size for the training set:
This information is not applicable as the device is not an AI/ML algorithm that would typically have a "training set."
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence based on technological characteristics and safety testing (biocompatibility, electrical safety, software validation, sterilization, shelf-life, and ex vivo thermal tests), rather than presenting a clinical study with detailed performance acceptance criteria and results against those criteria.
§ 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.