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The Indications for Use of the Safe-T-Clamp TM are to simultaneously clamp and cut the umbilical cord

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The provided documents K971277 and its attachment are a 510(k) clearance letter from the FDA for a device called "Safe-T-Clamp™ Umbilical Cord Clamp and Cutter." This type of document does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of AI/machine learning.

Here's why and what information is missing:

• Device Type: The Safe-T-Clamp is a physical medical device (an umbilical cord clamp and cutter), not an AI/software device. The questions in the prompt are specific to AI/ML device performance and validation.
• 510(k) Process: A 510(k) clearance demonstrates substantial equivalence to a predicate device. It typically relies on performance testing for safety and effectiveness relevant to the physical device's function (e.g., clamping force, material biocompatibility, cutting ability), not complex algorithmic performance metrics like sensitivity, specificity, or AUC against a ground truth.
• Missing Information: All points (1-9) in your request are related to the validation of an AI/ML algorithm's performance against a gold standard, including statistical metrics, data sets, expert review, etc. This information would not be present in a 510(k) for a physical, non-AI device.

Therefore, I cannot provide the requested details based on these documents.

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