(43 days)
MainStream® OR Surgical Light Control (MSLC) allows the control of surgical lights from the Mainstream® OR touch panel user interface. It does not perform calculations. It displays surgical light status on the MainStream® OR display and allows control of the surgical lights. The safety features and controls of the surgical light system take precedence over the MainStream® OR surgical light control.
MSLC is an optional function in the MainStream® OR integrated operating room system. (The MainStream® OR system includes a touch panel user interface for quick routing of surgical images to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights. MainStream® OR also includes an audio management system and a single point of entry for querying surgical charts and image archives.)
The MainStream® OR Surgical Light Control (MSLC) is an optional function in the MainStream ® OR, which is an integrated operating room system for configurable communication of images from sources to displays within the operating room, for management of audio systems, and for control of devices such as room lights.
The MSLC function allows control of surgical lights from the MainStream® OR touch panel user interface.
The provided text does not contain information about acceptance criteria and a study to prove the device meets those criteria. This device, the MainStream® OR Surgical Light Control (MSLC), is a surgical light accessory that enables control of surgical lights from an integrated operating room system's touch panel. The submission primarily focuses on establishing substantial equivalence to a predicate device (SCB/Steris OR-Light Interface Box) based on functional similarities and safety principles rather than performance metrics.
The document states that the MSLC does not perform calculations and that the safety features and controls of the surgical light system take precedence over the MSLC. This implies that the MSLC's function is primarily an interface and control mechanism, and its safety is intrinsically linked to the underlying surgical lighting system it controls.
Therefore, I cannot provide a table of acceptance criteria or details about a study as requested. The available information describes the device's function and its classification, but not specific performance testing or clinical studies.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.