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510(k) Data Aggregation
(350 days)
Various components are to be used for intra-abdominal Laparoscopic surgery and procedure.
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The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria for an AI/ML-based medical device.
The document is for a "Reusable, Disposable Laparoscopic Instrument and Surgical Device and Accessories" and is a traditional medical device, not an AI/ML product. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements.
Therefore, I cannot provide the requested information, such as acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods, as these are not present in the provided text.
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(120 days)
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