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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, coagulation and hemostasis of tissue within the digestive tract.

Diathermic Slitter (FlushKnife) is sterile and intended for single used electrosurgical instruments that remove tissue and control bleeding by use of high-frequency ("HF") electrical current. The device is 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 high frequency (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 and retraction of the distal end of the operation wire connects to the slitter, which is located at the distal tip of the device. The device connects to a HF electrosurgical power supply unit by an active cord ("A-Cord") connector. HF electrical current generated by a HF electrosurgical power supply unit flows to the slitter from the HF electrosurgical power supply unit via the A-cord, 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 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 device is provided sterile for single-use only. The device can supply sterile water or fluids to its distal end target site via a water/fluid supply channel. The port for the water/fluid supply channel is located on the handle at the proximal end of the device. The sterile water or fluid also aids in the removal of debris, blood and extraneous material from the distal end of the device or a target site. To supply sterile water or fluid to the distal end target site, a syringe filled with water or fluid is connected to the water/fluid inlet at the proximal handle. Besides a syringe, alternate delivery methods can also be used to supply sterile water or fluid to the distal end target site of the device.

The provided text describes a 510(k) submission for a medical device called the "Fujifilm Diathermic Slitter (FlushKnife)," which is a modified version of a previously cleared device. The submission focuses on demonstrating substantial equivalence to the predicate device, especially regarding a minor modification: the addition of compatible sterile fluids and alternate delivery systems.

Here's an analysis of the acceptance criteria and study information provided, focusing on what's explicitly stated and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a detailed table with specific numerical acceptance criteria and a corresponding reported performance for each criterion. It mentions categories of performance testing but does not quantify them.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The text states "Fujifilm conducted the following performance testing," but no details about sample sizes or the origin of the test data (e.g., country of origin, retrospective/prospective) are mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/provided. The performance testing described (fluid supply, temperature rise, dielectric voltage, durability) are engineering/functional tests, not tests that require expert-established ground truth related to clinical outcomes or interpretations.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As above, the tests mentioned are functional performance tests, not clinical evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is an electrosurgical instrument for cutting tissue, not an imaging or diagnostic device that would typically involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The concept of "standalone performance" for an algorithm does not apply to this device. This is a physical electrosurgical instrument, not an AI or algorithmic device. The performance tests described (fluid supply, temperature rise, dielectric voltage, durability) are inherent to the device's physical function.

7. The Type of Ground Truth Used

The ground truth for the performance tests would be established through engineering specifications and standards relevant to medical device safety and performance. For example:

• Fluid supply: Met predefined flow rates or delivery volumes.
• Temperature rise: Stayed within safe operating temperature limits.
• Dielectric voltage: Withstood specified voltage without breakdown.
• Durability: Maintained functional integrity after a specified number of uses or cycles.

These are not "expert consensus," "pathology," or "outcomes data" in the typical clinical sense, but rather objective measurements against established engineering benchmarks.

8. The Sample Size for the Training Set

This information is not applicable/provided. As this is a physical medical instrument and not an AI or machine learning device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the same reason as point 8.

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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, 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 Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter) are electrosurgical instruments intended to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. The FlushKnife has needle or ball tip shapes and varying slitter lengths and working lengths. The ClutchCutter has a forceps type slitter shape and a working length of 1800mm. Both devices have a water feed function, are operated manually via a handle slider, use monopolar energy delivered from an electrosurgical generator, are single-use devices, and are biocompatible.

The provided text is a 510(k) premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a clinical study or effectiveness study with human readers.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or not provided in this document.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document states that "In all cases, the device met the pre-defined acceptance criteria for the test." However, the specific acceptance criteria values are not detailed in this summary for each test. The tests performed were:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The studies mentioned are engineering/performance testing, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the tests were performance testing of physical device attributes, not diagnostic performance requiring expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for physical device performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a physical medical device (electrosurgical slitter), not an AI-powered diagnostic tool, so this type of study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance tests, the "ground truth" would be established engineering specifications and measurement standards. For example, "Working length" would have a defined specification, and the device's measured length would be compared against it. This is not explicitly detailed in the summary, but it's inherent to engineering performance testing.

8. The sample size for the training set

This information is not applicable as there is no training set for an AI or algorithm in this context.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for an AI or algorithm in this context.

Summary of the Device and its Review:

The document describes a Special 510(k) for the Fujifilm Diathermic Slitter (FlushKnife) and Diathermic Slitter (ClutchCutter). The purpose of this submission is to address a minor modification (change in material - epoxy resin) to an already cleared predicate device (K151474). The core argument for substantial equivalence is that the intended use, indications, technological characteristics, and principles of operation remain the same as the predicate device. The performance tests conducted (e.g., airtightness, working length, electrical resistance) were to ensure that the modified device performs equivalently to the predicate and met pre-defined acceptance criteria. The document concludes that these minor differences do not raise new questions of safety or efficacy.

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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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