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The LuxScope is indicated for panretinal photocoagulation and ablation of the ciliary processes.

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This document is an FDA 510(k) clearance letter for the LuxScope device, dated November 21, 1997. It confirms that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided document, the following information regarding acceptance criteria and study details cannot be found:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance
• If a standalone (algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

This letter primarily focuses on the FDA's determination of substantial equivalence based on the provided 510(k) submission, confirming that the device can be legally marketed. It does not contain details of specific performance studies or the acceptance criteria used in such studies, which would typically be found in the original 510(k) submission itself, not the clearance letter.

The relevant information from the document is:

• Trade Name: LuxScope
• Regulatory Class: II
• Product Code: HQF
• Indications for Use: The LuxScope is indicated for panretinal photocoagulation and ablation of the ciliary processes.

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