(23 days)
The Beamer AVEO™ Filter Integrated Argon Probes and Beamer AVEO™ Filter Integrated Argon SideFire Probe are intended to be used for argon enhanced coagulation of tissue.
The Beamer AVEOTM Argon Probes and Argon SideFire Probe are flexible, single patient use devices which deliver argon for non-contact coagulation when used in conjunction with the Beamer AVEOTM Electrosurgical Generator (ESU) and Argon (ABC) Module. The axial probes are offered in several lengths and diameters to accommodate various endoscope types. The distal end of all the probes has a ceramic tip which provides a thermal insulation barrier for the tubing to prevent heat degradation during coagulation.
The provided text is a 510(k) Summary for a medical device (Beamer AVEO™ Filter Integrated Argon Probes) and does not describe a study involving acceptance criteria for an AI/ML powered device. Instead, it details the substantial equivalence of the new device to a predicate device, focusing on changes in mechanical design and integration of components.
Therefore, I cannot provide the requested information as the document does not contain details about:
- Acceptance criteria and device performance table for an AI/ML device.
- Sample sizes for test sets, data provenance, number of experts, or adjudication methods for ground truth.
- MRMC studies, standalone algorithm performance, or ground truth types, training set size, or ground truth establishment for an AI/ML model.
The document discusses performance testing for the physical device, such as thermal effects on tissue and mechanical tests (flow rate, insertion/retraction, tensile strength), and states that "All test results were acceptable." However, it does not provide specific acceptance criteria or detailed results of those tests. It also mentions biocompatibility testing confirming material safety.
The core of this submission is a claim of substantial equivalence for a non-AI/ML medical device, based on similar materials, processes, packaging, and technological characteristics to a predicate device, with minor modifications (like an integrated filter and a new connector).
§ 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.