(15 days)
The Aurora LED series surgical light is intended to provide local illumination at the surgical site on the patient's body at Hospitals, Clinics, VA's, Freestanding Surgical centers, Ambulatory/Care Centers and Doctor's offices.
The SKYTRON Aurora series surgical light fixture is intended to be used by medical personnel for the purpose of illuminating surgical sites.
The Aurora LED series surgical light is suitable for all types of surgical procedures. The Aurora series surgical light is intended to provide local surgical site illumination throughout the patient's body providing a high-intensity, shadow-free "cold" pattern of light. The lights consist of several modules containing LEDs (light emitting diodes) and optical color corrective reflectors. Each light head features independent focus capability allowing the user to adjust the illumination parameters. The light intensity is adjustable between 10% - 100% and a color temperature of 4000K - 4500K creating the infinite capability to adapt to different situations. LEDs offer low heat radiation and increased illumination and are energy saving.
The provided text is a 510(k) Summary for a medical device (Aurora LED Series Surgical Light). It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
Instead, it focuses on demonstrating substantial equivalence to a predicate device (STELLAR Series Surgical Light, K002463) based on its intended use and a primary difference in the light source (LED vs. traditional incandescent bulbs), highlighting the LED's longer lifetime and energy efficiency as improvements.
Therefore, I cannot provide the requested information from the given text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone performance studies.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
The document is a regulatory submission for premarket notification, where the primary goal is to show the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance study results against specific criteria.
§ 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.