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These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.

FUJIFILM Diathermic Slitter (FlushKnife) is an electrosurgical instrument that removes tissue and controls bleeding by use of high-frequency ("HF") electrical current. The device is available with either a needle or ball tip slitter and comes in a variety of sizes.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device. It does not contain information about an AI/ML medical device or a clinical study with human subjects, therefore, most of the requested information cannot be extracted from the document. The document describes a Diathermic Slitter (FlushKnife) used for endoscopic treatments in the gastrointestinal tract. This is a physical, electrosurgical instrument, not an AI or software-based device.

Therefore, many of the requested fields related to AI/ML device performance, such as sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, and training set details, are not applicable to this document.

However, I can provide information based on the "Performance Data" section regarding the device's technical validation.

Here's what can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device met pre-defined acceptance criteria for all tests. Specific numerical acceptance criteria or performance metrics are not detailed in this summary; rather, it refers to compliance with standards and successful completion of tests.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified for any of the performance tests. The document refers to "bench testing" and evaluations against standards, which typically involve a specified number of samples, but these numbers are not disclosed.
• Data Provenance: The testing appears to be conducted by the manufacturer as part of their submission for regulatory clearance. The document doesn't specify country of origin for data but states the manufacturer is FUJIFILM Corporation, located in Japan. The tests are described as "bench testing," implying a laboratory, likely prospective testing for the purpose of the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This document describes a traditional electrosurgical device, not an AI/ML device that requires expert-established ground truth for image interpretation or diagnosis. Ground truth, in this context, refers to the physical properties and performance characteristics of the device being measured against engineering specifications and regulatory standards.

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

• Not Applicable. As this is not an AI/ML device relying on human interpretation, an adjudication method for test set ground truth is not relevant.

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

• No. This is not an AI/ML device and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.

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

• No. This is not an algorithm or software device. Its performance is evaluated intrinsically as a physical piece of medical equipment.

7. The type of ground truth used

• Technical Specifications and Consensus Standards: The "ground truth" for this device's performance relies on its ability to meet engineering design specifications and comply with recognized consensus standards for electrical safety, biocompatibility, sterility, and device-specific functionalities (e.g., slitter length, conductivity). This is established through laboratory testing and verification against pre-defined performance metrics, rather than expert consensus on diagnostic interpretations or clinical outcomes data in a comparative study.

8. The sample size for the training set

• Not Applicable. This device uses traditional engineering principles, not machine learning, and therefore has no "training set."

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

• Not Applicable. There is no training set for this type of device.

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Blue Beacon™ Submucosal Injectable Solution is indicated for submucosal lift of polyps, adenomas, early state cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

Blue Beacon™ Submucosal Injectable Solution is indicated for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device. Under the surveillance of endoscope, in conjunction with endoscopic injection needles with a diameter equal to or greater than 23G are recommended), inject the product beneath the lesion until enough submucosal lift. It is supplied in a 5 mL, 10ml syringe. The contents of the syringe are sterile and nonpyrogenic. The proposed devices are moist heat sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 2 years.

The provided document describes the Micro-Tech (Nanjing) Co., Ltd. Blue Beacon™ Submucosal Injectable Solution (K200071) and its substantial equivalence to a predicate device. This document is a 510(k) summary, which focuses on demonstrating equivalence rather than providing detailed acceptance criteria and a comprehensive study report with statistically significant outcomes against specific acceptance thresholds for a diagnostic AI device.

Therefore, the requested information, which is typical for a diagnostic AI device requiring performance against quantitative acceptance criteria, is largely not present in this type of submission. The device described is a medical injectable solution, not an AI or diagnostic device.

However, I can extract the available information which pertains to device performance and testing, and explain why other requested details are not applicable or provided in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a non-AI injectable solution, there are no "acceptance criteria" in the sense of accuracy, sensitivity, or specificity metrics typical for AI or diagnostic devices. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Eleview™ Submucosal Injection Composition, K150852) and meeting general medical device standards.

The "acceptance criteria" are implicitly meeting the performance characteristics of the predicate device and relevant international standards.

Note on Differences: The differences in sterilization method, composition, and packaging are addressed by performance testing (bench tests, syringe tests, biocompatibility, sterilization validation) to demonstrate that these differences do not raise new questions of safety or effectiveness. The conclusion is that despite these differences, the devices are "substantially equivalent."

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

• Sample Size for Test Set: Not explicitly stated numerically for "bench performance tests" (Appearance, Content, pH, etc.) or for the pre-filled syringe tests. The document mentions "a series of bench performance tests" and "a series tests were conducted" which implies multiple samples were tested under each category.
• Data Provenance: The studies were conducted by Micro-Tech (Nanjing) Co., Ltd. in China, as indicated by the company's address and the origin of the submission. The studies are retrospective in the sense that they are conducted on manufactured devices and evaluated against established standards and the predicate device's characteristics.

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

This information is not applicable and not provided as the device is an injectable solution, not a diagnostic device requiring expert interpretation of results or images. The "ground truth" for the performance tests would be objective measurements against specified physical/chemical properties or validated standards.

4. Adjudication Method for the Test Set

This information is not applicable as the device is not a diagnostic device requiring adjudication of human reader interpretations.

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

This information is not applicable as the device is not an AI diagnostic tool and therefore no MRMC studies involving human readers and AI assistance would be performed.

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 AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics of this device is based on:

• Objective measurements of physical and chemical properties (e.g., pH, viscosity, content, colorant concentration).
• Compliance with international standards for medical device safety and performance (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization, ASTM F1980 for accelerated aging).
• Comparison to the established characteristics of the legally marketed predicate device (K150852) to demonstrate substantial equivalence.
• Animal testing for safety and effectiveness, conducted under GLP Regulations (21 CFR §58), is also cited as "ground truth" for in-vivo performance.

8. The Sample Size for the Training Set

This information is not applicable as the device does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable as the device does not involve a "training set."

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