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KD-625
These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract.
These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.

KD-645
This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using highfrequency current within the digestive tract.
This instrument is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.

These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
This system consists of the electrosurgical knives (subject devices), flushing pump, and water tubes (accessories). The subject devices are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. They will be marketed as sterilized (ETO) devices for single use.

This document describes the premarket notification for the Olympus Single Use Electrosurgical Knives KD-625 and KD-645. It does not contain information about an AI/ML device. Therefore, I cannot provide details on acceptance criteria and study designs related to an AI/ML device from this document.

However, I can extract the general performance data and acceptance criteria mentioned for these electrosurgical knives:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML Device):

Since this document is for a traditional electrosurgical knife and not an AI/ML device, the following points are not applicable or cannot be extracted from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models typically involves expert annotation of data.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for an electrosurgical tool, not an interpretive diagnostic aid.
6. Standalone (algorithm only without human-in-the loop performance) performance: Not applicable.
7. Type of ground truth used: Not applicable for an AI/ML device; for this device, ground truth established by physical and functional testing.
8. Sample size for the training set: Not applicable (no AI/ML model for training).
9. How the ground truth for the training set was established: Not applicable.

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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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