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The Blue Eye is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device.

Blue Eye, submucosal injection agent, is a solution used for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device in gastrointestinal endoscopic procedures. The main materials of the solution are sodium hyaluronate and saline, and it is provided in prefilled syringe. It is supplied sterile and disposable.

This is a 510(k) premarket notification for a medical device called "Blue Eye" (model TS-910), a submucosal injection agent used in gastrointestinal endoscopic procedures. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, "Blue Eye" (model TS-905) (K220434), manufactured by the same company.

The provided document describes physical and performance characteristics, but does not include any clinical study data or acceptance criteria relating to device performance for diagnostic accuracy or clinical effectiveness.

The document states that the substantial equivalence determination is based on an assessment of non-clinical performance data. Therefore, the information requested regarding acceptance criteria and a study proving device meets these criteria in a clinical context cannot be fully provided from the given text.

However, I can extract the relevant information from the provided text regarding the non-clinical performance studies conducted:

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

The document does not explicitly state specific numerical acceptance criteria for each non-clinical test, nor does it provide detailed quantitative performance results. It generally states that "The tests were performed on the subject device using the same method as the predicate device, and acceptance criteria," and that based on the results, the device is "as safe and effective and performs as well as the legally marketed predicate device."

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

The document does not specify the sample sizes used for any of the non-clinical performance tests. There is no information about data provenance because these are non-clinical (laboratory/engineering) tests, not involving human subjects or real-world data collection in a clinical setting.

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

This question is not applicable. The studies described are non-clinical engineering and laboratory tests, not clinical studies requiring expert consensus for ground truth establishment.

4. Adjudication method for the test set

This question is not applicable for the same reason as above.

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 conducted. This device is a submucosal injection agent, not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.

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

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

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the specific parameters and requirements outlined in the referenced ISO and ASTM standards (e.g., sterilization effectiveness, packaging integrity, syringe function). The tests simply confirm whether the device meets these established engineering and safety standards.

8. The sample size for the training set

This is not applicable. There is no "training set" as this device is not a machine learning model.

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

This is not applicable as there is no training set.

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The Blue Eye (TS-905) is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions with a snare or endoscopic device.

The Blue Eye (TS-905), submucosal injection agent, is a solution used for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device in gastrointenstinal endoscopic procedures. The main materials of the solution are sodium hyaluronate and saline, and it is provided in prefilled syringe. It is supplied sterile and disposable.

This is not an AI/ML SaMD product. The provided text is a 510(k) summary for a medical device called "Blue Eye (TS-905)," which is a submucosal injection agent used in gastrointestinal endoscopic procedures. The information pertains to traditional medical device clearance, not an AI/ML-driven software device.

Therefore, the specific information requested about acceptance criteria, study details for AI/ML performance, sample sizes for test and training sets, expert qualifications, and adjudication methods for AI/ML ground truth cannot be extracted from this document because it is not applicable to this type of device.

The study described is a non-clinical performance test comparing the device to a predicate device, focusing on sterilization, shelf-life, biocompatibility, and physical characteristics. There is no mention of an algorithm or AI/ML components.

Ask a specific question about this device