(13 days)
The Leo Minor is intended to provide visible illumination of the surgical field and the patient during surgical and non surgical procedures.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific criteria.
The document is a 510(k) clearance letter from the FDA for a surgical lamp called "Leo Minor." It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. The letter also includes the "Indications for Use" for the device, stating it is "intended to provide visible illumination of the surgical field and the patient during surgical and non-surgical procedures."
This type of document does not typically include detailed performance data, acceptance criteria, or study results. This information would usually be found in a separate submission document or a scientific publication.
§ 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.