(45 days)
The Headlight is indicated for use in transmitting illumination to a body cavity or surgical procedure.
Not Found
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for the IsoLED AC-Powered LED Headlight System, indicating that the device has been found substantially equivalent to a predicate device.
It includes:
- Device name: IsoLED AC-Powered LED Headlight System
- Regulation Number and Name: 21 CFR 878.4580, Surgical lamp
- Regulatory Class: Class II
- Product Code: FST
- Indications for Use: "The Headlight is indicated for use in light transmitting illumination and body cavity illumination procedures."
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information on MRMC comparative effectiveness studies or standalone performance.
- Training set details.
Therefore, I cannot fulfill your request based on the provided text.
§ 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.