(147 days)
The BRAVO G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterlizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The BRAVO G4 has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
Not Found
The provided text describes a 510(k) premarket notification for a steam sterilizer, the BRAVO G4 Chamber Autoclave. It outlines the device's indications for use and lists various sterilization cycles with their parameters. However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to software performance, AI algorithms, or diagnostic accuracy.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types, as these are not present in the provided text.
The document focuses on the regulatory clearance of a physical medical device (a steam sterilizer) and its operational parameters, not on an AI or software-driven medical device.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).