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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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