(41 days)
The Stellartech Radiofrequency Generator is indicated for use in general surgical procedures to coagulate soft tissues. The Stellartech Radiofrequency Generator may also be used to coagulate blood and soft tissues to produce hemostasis.
The Stellartech Radio Frequency Generator (Model 1025A-115 and Model 1025A-230) is indicated for use in general surgical procedures to cut and coagulate soft tissue.
The Stellartech Radiofrequency Generator is capable of supplying up to 25 watts of radiofrequency energy in unipolar mode to an electrode or electrodes in contact with tissue while continuously monitoring and displaying actual power delivered, tissue impedance, and time of power duration. User controls are provided for setting desired power and maximum time of power duration. Safety features include overvoltage, overcurrent, and overpower shutdowns. Each generator is tested for leakage current, dielectric withstand, and control of power delivery prior to quality control release.
This document is a 510(k) Safety Summary for a medical device, the Stellartech Radiofrequency Generator. It is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/human performance study.
Specifically, the document does not contain the following:
- A table of acceptance criteria and the reported device performance in the context of AI/human performance. The document lists technical features and compliance with safety standards, but these are general engineering and safety requirements, not performance metrics for an AI medical device.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, or its effect size.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) in the context of AI.
- The sample size for the training set.
- How the ground truth for the training set was established.
The provided document describes a traditional medical device (Radiofrequency Generator) and its submission for regulatory clearance based on substantial equivalence to a predicate device, not an AI or software-as-a-medical-device (SaMD) product. The "study" mentioned in the document refers to "a series of physical, electrical, and functional tests" to demonstrate technical equivalence and compliance with safety standards, not a clinical or AI performance study.
§ 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.