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The SB Knife™ is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

The SB Knife™ is a single-patient use EtO-sterilized hand-held device that connects to an external high frequency (HF) generator and is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The SB Knives are designed to connect with Olympus and ERBE connectors and use the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators.

The device is not life supporting or life sustaining. It is designed as a short-term limited contact device (less than 24 hours), has no software, and has been certified to comply with IEC 60601-1 and IEC 60601-2-2 and IEC 60601-2-18 by UL Japan

This document is a 510(k) premarket notification for the SB Knife, an electrosurgical knife. It does not describe an AI medical device or a study involving acceptance criteria for an AI device's performance. Therefore, I cannot extract the requested information regarding acceptance criteria and studies that prove the device meets these criteria in the context of AI.

The document discusses the following:

• Device Name: SB Knife Jr Type, SB Knife Short Type, SB Knife Standard Type, SB Knife Jr Type - Long
• Regulation Number: 21 CFR 876.4300
• Regulation Name: Endoscopic Electrosurgical Unit and Accessories
• Regulatory Class: Class II
• Product Code: KNS
• Predicates: Olympus Medical Systems, Corp. IT Knife 2/ Hook Knife/ Flex Knife/ Triangle Tip Knife Electrosurgical Knife (K092309)
• Indications for Use: To be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors, and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
• Non-Clinical Testing: Comparative bench and animal tissue testing was performed for tissue ablation, resection, incision, cauterization, hemostasis, coagulation, vaporization, and dissection of tissues using Olympus and ERBE monopolar HF generators.
• Clinical Testing: "Clinical testing was not performed for this medical device."

Since the SB Knife is a physical electrosurgical tool and not an AI device, the provided information does not contain the specific details requested for an AI acceptance criteria study (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI).

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