DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD

• K Number: K042382
• Device Name: DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD
• Manufacturer: MED-GENERAL TECHNOLOGIES LLC
• Date Cleared: 2004-11-30 ( 90 days)
• Product Code: FSY
• Regulation Number: 878.4580
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

no a lami i [ fuinsi no in icadores ties during examinations or minimal invasive surgical procedures

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Dual LED Lite Engine with Illumination LED Cable Coupled to a LED Lite Head), which signifies that the device is substantially equivalent to a predicate device. This type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, or ground truth establishment.

The letter focuses on regulatory clearance, not the technical and clinical performance data that would typically be found in a study report or a summary of safety and effectiveness.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Regulation Number and Section

§ 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.