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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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The instrument is used to cut and coagulate the selected tissue for Laparoscopic procedure.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a Laparoscopic Instrument and Electrode Tips. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations it must comply with.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory approval document, not a study report.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them based on the provided text.

Ask a specific question about this device