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Telesopes (laparoscopy): Telescopes are used to illuminal cavity) by means of an external light source and to transmit an optical image from inside the cavity.

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The provided text is a 510(k) clearance letter from the FDA for "Trocar Systems and Rigid Endoscope Systems." This document approves the marketing of these devices based on their substantial equivalence to predicate devices. However, the letter itself does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information from the given input. The letter states that the FDA reviewed the 510(k) notification and determined substantial equivalence, implying that such studies and data were submitted, but the specific details are not present in this document.

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The SEPS Videoscope is a telescope with working channel and outer sheath for the endoscopic sufascial dissection of the venea perforantes and fasciotomy. The instrument is introduced into a natural or artificial body cavities to illuminate them and to transmit an optical image from inside the cavity. The working channel allows to introduce instruments into the cavity.

The SEPS Videoscope is a telescope with working channel and outer sheath.

The provided document is a 510(k) summary for the "ETB Telescope w/ Working Channel for SEPS" and primarily focuses on the FDA's "substantially equivalent" determination to a predicate device. It does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or the detailed aspects of a clinical study as requested.

Therefore, I cannot provide the requested information from this document. The document primarily serves as an FDA clearance letter based on a regulatory review, not a detailed scientific study report.

Ask a specific question about this device