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The Interceptre™ Endoscopic Instruments are indicated for use in endoscopic/laparoscopic procedures.

The Interceptre™ Endoscopic Instruments are a family of graspers, dissectors, and scissors which are intended to be used to grasp, manipulate, cut, cauterize soft tissue.

The Interceptre™ Endoscopic instruments are a line of hand-held , non-sterile, reusable instruments

The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found in a performance evaluation or clinical study report for an AI/ML medical device.

Instead, this document is a 510(k) summary for the "Interceptre™ Laparoscopic Instruments," which are minimally invasive surgical instruments and not an AI/ML device. The document focuses on demonstrating substantial equivalence to predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these concepts are not applicable to the type of device and submission described.

The document demonstrates substantial equivalence by comparing the Interceptre™ Laparoscopic Instruments to legally marketed predicate devices (Karl Storz Take-Apart Endoscopic Instruments and Richard Wolf Laparoscopic Instruments) based on:

• Product Labeling: Non-sterile/reusable
• Materials: Stainless steel/Kynar insulation
• Indications: Endoscopic Surgical Procedures
• Intended Use: Management of Soft Tissue
• Tip Styles: Graspers, dissectors, scissors
• Number of separate components: 3
• Design: Dual/single action jaw design with 360-degree rotation

The FDA's letter states that they reviewed the 510(k) notification and determined the devices are substantially equivalent, allowing them to be marketed. This regulatory process for these types of instruments relies on demonstrating equivalence to existing devices rather than performance against specific analytical or clinical acceptance criteria for an AI/ML algorithm.

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The Interceptre™ Endoscopic Instruments are a family of graspers, dissectors, and scissors which are intended to be used to grasp, manipulate, cut, cauterize soft tissue.

The Interceptre™ Endoscopic instruments are a line of hand-held, non-sterile, reusable instruments

This document does not contain the information required to answer your request. The provided text is a 510k summary for "Interceptre™ Laparoscopic Instruments" and details administrative information, device description, and intended use. It does not include any acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth information typically associated with studies proving device performance, especially in the context of AI or advanced analytical devices.

Ask a specific question about this device