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The Subcutaneous Illuminator is indicated for transillumination and irrigation during endoscopic resection of superficial varicosities of the lower extremities.

The Smith & Nephew Subcutaneous Illuminator transfers light to the surgical site via glass fiber optics and includes irrigation via an irrigation channel. The Subcutaneous Illuminator allows it to gain access to the surgical site.

The provided K99/323 510(k) summary for the Smith & Nephew Subcutaneous Illuminator does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, function, and intended use. The FDA letter confirms the substantial equivalence primarily based on these comparisons.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.

The primary "proof" of the device's acceptability in this context is its substantial equivalence to already legally marketed devices, rather than a specific performance study with measured acceptance criteria.

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