(300 days)
SIAscope is a self -contained non-invasive skin analysis system, which provides a synthesized 'image' showing the relative location of blood, collagen and pigment.
SIAscope is a self -contained non-invasive skin analysis system, which provides a synthesized 'image' showing the relative location of blood, collagen and pigment.
I apologize, but the provided text only contains an FDA 510(k) clearance letter for a device called "SIAscope." This letter confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory information.
However, it does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications. Therefore, I am unable to provide the detailed answer you requested based solely on the provided input.
To answer your questions, I would need access to the actual 510(k) submission summary or a separate study report for the SIAscope device.
§ 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.