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510(k) Data Aggregation
(90 days)
50 W METAL HALIDE ILLUMINATOR, VES 0501.
The 50 W Metal Halide Illuminator has indicated use in the following situations:
- There is a requirement for illuminating medical headlamps.
- There is a requirement for fiber-optic illumination for endoscopy applications.
- There is a requirement to use video as a visual aid or a method of recording or both.
- There is a requirement for any or all of the above at the same time.
Not Found
The provided document [0] is a 510(k) clearance letter from the FDA for a device called "VES 0501. 50 Watt Metal Halide Illuminator." This type of letter confirms substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.
The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related details requested in the prompt.
The closest information it provides in terms of device function are the "Indications For Use" listed in document [1], which describe where the device is intended to be used (illuminating medical headlamps, fiber-optic illumination for endoscopy, and with video systems). However, these are not performance metrics or acceptance criteria derived from a study.
Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text. The document is merely a regulatory clearance, not a technical report or study summary.
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