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Diathermic Slitter (FlushKnife) DK2618J and DK2623J are intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The devices are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.

Diathermic Slitter (ClutchCutter) DP2618DT is intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The device is indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.

The Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter) (the "devices") are electrosurgical instruments that remove tissue and control bleeding by use of high-frequency ("HF") electrical current. The devices are provided sterile for single-use only. The devices are provided in various models (described below), but each is comprised of the following major components:

The FlushKnife and ClutchCutter consist of the following major components:

• · Slitter Electrode at distal tip of the device that performs ablation, incision, dissection, avulsion, cauterization, coagulation, and hemostasis of tissue via delivery of HF electrical current.
• Operation wire Inner wire of the device that connects the handle and slider control to the slitter, facilitates manual control of slitter position, and delivers the HF electrical current to the slitter.
• · Tube Flexible resin tube that is inserted into body cavities and insulates operation wire carrying the HF electrical current.
• Slider Portion of handle that extends and retracts the slitter portion from the distal end of the tube (FlushKnife) or opens and closes slitter jaws (ClutchCutter) by means of the operation wire.
• · Handle Proximal end of the device that provides for user control.
• · Active Cord ("A-Cord") Connector Used to connect the device to the electrosurgical power supply unit via an A-cord.

The devices are comprised of a proximal handle with slider that is connected to a flexible resin tube. The flexible resin tube covers and insulates the operation wire and slitter (when retracted). The operation wire controls the mechanical function of and delivers HF electrical current to the slitter. The proximal end of the operation wire is connected to the slider, which allows the operator to manually control the extension of the slitter (for the FlushKnife) or open and close (ClutchCutter) of the slitter Jaws. The distal end of the operation wire connects to the slitter, which is located at the distal tip of the device.

The devices connect to a HF electrosurgical power supply unit by an active cord ("A-Cord") connector. HF electrical current generated by HF electrosurgical power supply unit flows to the slitter from the HF electrosurgical power supply unit via the A-cord connector, and the operation wire.

The distal tip of the device is inserted through the forceps channel of the specified endoscope. Once inserted, the operator can extend the slitter from the tip of the endoscope (FlushKnife) or opens and closes slitter jaws (ClutchCutter) using the slitter is extended to the target site of a patient. Cleavage, resection, incision, ablation, hemostasis, coagulation, or excision of tissue is achieved by delivering HF current to the target tissue through the slitter.

The provided text describes a 510(k) premarket notification for electrosurgical instruments (Fujifilm Diathermic Slitter FlushKnife and ClutchCutter). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on performance studies with human-in-the-loop or standalone AI.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of an AI/human comparative effectiveness study.

The performance data mentioned in the document are related to safety and effectiveness through compliance with recognized consensus standards (biocompatibility, sterilization, EMC, electrical safety, as well as standards related to packaging and shelf life) and bench testing, primarily to demonstrate that the new device is as safe and effective as the predicate devices.

Here's why the requested information cannot be extracted:

• Acceptance Criteria & Reported Device Performance (Table 1): The document does not define specific performance metrics (e.g., sensitivity, specificity, accuracy, or other clinical outcomes) as acceptance criteria for the device's function that would typically be evaluated in an AI-related study. Instead, it compares the technological characteristics of the subject device to predicate devices to establish substantial equivalence.
• Sample Size for Test Set & Data Provenance: This information is not explicitly provided because the studies conducted are primarily bench tests and compliance assessments against standards, not clinical performance studies with a "test set" of patient data.
• Number of Experts & Qualifications / Adjudication Method: These points are relevant for studies determining ground truth in diagnostic or AI applications. The document describes electrosurgical instruments, not a diagnostic or AI device that requires expert review for ground truth.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication that such a study was performed. The device is an electrosurgical tool, not an AI-assisted diagnostic system where human readers would be evaluated with and without AI assistance.
• Standalone Performance (Algorithm Only): The device is a physical electrosurgical instrument; there is no mention of an associated algorithm or AI component that would have standalone performance.
• Type of Ground Truth Used: "Ground truth" in the context of this document is related to the physical and electrical safety and performance of the instrument as measured by engineering and material standards, not clinical ground truth derived from expert consensus, pathology, or outcomes data in a diagnostic sense.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: These concepts are entirely absent as the device is not an AI/machine learning product.

In summary, the provided text describes a submission for an electrosurgical instrument, not a device involving AI or complex clinical diagnostic performance metrics as typically seen in AI/ML medical device submissions.

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