(6 days)
The CHROMOPHARE® E 668 is intended to be used to provide visible illumination to the surgical field of the patient. The surgical lights BERCHTOLD CHROMOPHARE® E 668 is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
The new BERCHTOLD CHROMOPHARE® E 668 surgical light is suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in this light, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other.
The provided text describes a 510(k) summary for the BERCHTOLD CHROMOPHARE® E 668 surgical lamp. The submission focuses on demonstrating substantial equivalence to a predicate device (BERCHTOLD CHROMOPHARE® E 558), rather than a study proving the device meets specific acceptance criteria for a novel AI or diagnostic system.
Therefore, many of the requested elements (like sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this type of regulatory submission as they pertain more to performance studies of diagnostic or AI-driven devices.
However, I can extract the acceptance criteria based on the comparison to the predicate device and the conformity to relevant standards.
1. A table of acceptance criteria and the reported device performance
For a substantial equivalence submission like this, the "acceptance criteria" are implicitly established by the characteristics of the predicate device and relevant performance standards. The new device is accepted if its performance characteristics are substantially equivalent to the predicate and conform to identified standards, without raising new questions of safety or effectiveness.
| Characteristic / Acceptance Criteria (Predicate E 558) | Reported Device Performance (New Device E 668) | Met/Not Met (Substantially Equivalent) |
|---|---|---|
| Intended use: Illumination of the operating site on a patient's body | Same | Met |
| Input power: 120V, 1-phase lines, 60Hz | Same | Met |
| Protection against electrical shock: Class I | Same | Met |
| Diameter of light body: 568mm | 638mm | Met (Difference assessed not to alter safety/efficacy) |
| Diameter of reflectors: 36x35mm, 36x40mm | 48x35mm, 48x40mm | Met (Increased number, assessed not to alter safety/efficacy) |
| Lamp technology: Light Emitting Diode | Same | Met |
| Reflector: 72 individual reflectors | 96 individual reflectors | Met (Increased number, assessed not to alter safety/efficacy) |
| Power consumption of bulb: |
§ 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.