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The Roth Net Retriever Product Line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.

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The provided text is a 510(k) clearance letter from the FDA for the Roth Net Retriever Product Line. It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, or AI-related metrics (such as effect size of human readers with/without AI assistance).

Therefore, I cannot fulfill your request for the following sections based on the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e. 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

The document primarily focuses on:

• Confirming the substantial equivalence of the Roth Net Retriever Product Line to legally marketed predicate devices.
• Outlining regulatory requirements the manufacturer must adhere to.
• Stating the intended use of the device.

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