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Horizons Reusable Hot Biopsy Forceps is intended to be used in the flexible endescope for transendoscopic, dissecting, and grasping tissue for biopsy.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Horizons Reusable Hot Biopsy Forceps). This type of document does not contain the information requested regarding acceptance criteria and study results.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials with detailed performance metrics like accuracy, sensitivity, specificity, or sample sizes for testing AI algorithms. Therefore, I cannot extract the following information from the given text:

• 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
• Adjudication method
• Multi reader multi case (MRMC) comparative effectiveness study information
• Standalone (algorithm-only) performance information
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

The document primarily states that the device is substantially equivalent to predicate devices for its intended use, which is "transendoscopic, dissecting, and grasping tissue for biopsy." It also lists regulatory information such as the regulation number, name, and product code.

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