(184 days)
The Mach LED SC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice.
The surgical light Mach LED SC is intended to illuminate the surgical field and the patient.
The surgical light Mach LED SC is intended to illuminate the surgical field and the patient. This light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards. The light system is operated by a keypad on the lamp head or, by special request of the customer, by a keypad on the wall.
The Mach LED SC consists of lamp housing, LED modules, optical -/electrical and mechanical components, one sterilizable handle sleeve as well as the cables.
One LED-module consists of one white LED.
The surgical light Mach LED SC will be market with merging of light fields and light intensity control. Colour temperature adjustment not available.
Available accessories for the Mach LED SC lighting systems are as follows:
- Camera module
- Remote control for camera module
- Remote control with network interface for camera module
- Single monitor yoke for flat panel monitors
- Double monitor yoke for flat panel monitors
- Instrument trays
- Trays for CRT monitors
- 24V DC battery backup support
- Low profile wall control unit
- Integrated laser pointer
- Sterilizable handle sleeves
This document is a 510(k) summary for the Dr. Mach LED SC surgical lamp, not a study report for a diagnostic AI device. Therefore, it does not contain information about acceptance criteria and performance data in the context of AI or machine learning algorithms.
The document primarily focuses on establishing substantial equivalence for a physical medical device (a surgical light) relative to existing predicate devices. It discusses non-clinical performance testing for compliance with electrical safety and EMC standards (EN 60601-1, EN 60601-2-42, EN 55015, EN 61000-4), but no clinical performance data is required or presented for this device classification.
Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as this information is not present in the provided document.
§ 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.