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Endoscopic light source to provide illumination for fibre optic endoscopy to joint cavities and abdominal space.

• Power Source
• Quartz Halogen Lamp
• Lamp illuminator adjuster

The provided text describes a 510(k) submission for a medical device called "Endospot," an endoscopic light source. The document focuses on comparing the Endospot to a predicate device (Autobrite) and providing administrative details for the submission.

Crucially, this document does not contain any information about acceptance criteria, performance studies, or clinical validation. It primarily details the technical specifications of the device and its intended use, along with a comparison to a substantially equivalent predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

The closest information available is the "Safety Testing" section, which mentions "TUV tested to IEC 601/1 1988," "DIN VDE 0750 TI/11.91," and "Electromagnetic compatibility tested." These are standards for electrical and electromagnetic safety, but they do not describe performance acceptance criteria in the context of diagnostic accuracy, which seems to be implied by your questions (e.g., "human readers improve with AI vs without AI assistance").

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