(89 days)
To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Traatek Cottonoid Patties." This document describes the regulatory approval of a medical device, specifically traditional cottonoid patties, based on its "substantial equivalence" to legally marketed predicate devices.
Critical Note: The information provided is for a traditional, physical medical device (cottonoid patties) and does not contain any details about an AI/ML-based device or a study proving its performance against specific acceptance criteria in the manner requested by the prompt. The prompt's questions are tailored for AI/ML device evaluations (e.g., sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance).
Therefore, I cannot provide the requested information from the given text. The FDA letter is a regulatory approval for a conventional medical product, not an AI/ML diagnostic or therapeutic system.
To answer your prompt, I would need a regulatory document or scientific publication detailing the development and validation of an AI/ML device, including performance metrics, study design, and ground truth methodologies.
§ 882.4700 Neurosurgical paddie.
(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).