(100 days)
The Baylis Medical Company Radiofrequency Perforation Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue.
The Baylis Medical Company (BMC) Radiofrequency Perforation Generator is used with a compatible, separately-cleared radiofrequency (RF) device. The RF device is connected to the generator through the appropriate BMC Connector Cable, and delivers power in a monopolar mode between its distal tip electrode and a commercially available external dispersive electrode. An optional footswitch (Model: RFA-FS) may be used with the generator.
The provided text is a 510(k) summary for the Baylis Medical Company Radiofrequency Perforation Generator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information (like acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, or MRMC studies) that you've requested.
The document indicates that "substantial equivalence of predicate and current generators is supported by the device similarities and the results of verification and validation testing." It also lists the standards to which the device conforms (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and ISO 14971).
To provide the information you've requested, one would need access to the full "verification and validation testing" report, which is not included in this 510(k) summary. These summaries are typically high-level documents highlighting the outcome of such testing, not the raw data or detailed methodologies.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria based solely on the provided text. The document confirms that testing was done and conforms to standards, but does not describe the specifics of those tests, the acceptance criteria, or the results in the granular detail requested.
§ 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.