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The IYUNNI™ 31D Tri-Funnel Feeding Tube Kit is indicated for use in percutaneous placement of a gastrostomy tube for feeding and/or medication in conjunction with an established gastrostomy tract. The gastrostomy tube may also be used for gastric decompression.

The IYUNNI™ 31D Tri-Funnel Gastrostomy Tube Kit is a percutaneous endoscopic gastrostomy tube kit comprising the Bard® Tri-Funnel Gastrostomy Tube along with the IYUNNI™ Soft Tip Introducer Dilator. Now, SaiNath Intellectual Properties intends to introduce its own gastrostomy tube as part of this kit. The Bard® Tri-Funnel Gastrostomy Tube is an all silicone tube with a balloon as the internal bolster and a silicone external bolster. The TYUNNI™ 3ID Tri-Funnel Feeding Tube kit will include, in addition to a gastrostomy tube the IYUNNI™ Soft Tip Introducer Dilator and a silicone external bolster.

This document is a 510(k) Premarket Notification for the IYUNNI™ 3ID Tri-Funnel Feeding Tube Kit. It aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove specific performance metrics against pre-defined acceptance criteria in the manner of a clinical trial for an AI device.

Therefore, the requested information components for AI device studies are largely not applicable to this type of regulatory submission. This document focuses on demonstrating that a new medical device is as safe and effective as a legally marketed predicate device, primarily through comparison of technological characteristics, materials, and intended use, often supported by bench testing and biocompatibility data.

Here's a breakdown of why many of your requested items are not found in this document:

• AI Device vs. Medical Device: This submission is for a physical medical device (gastrostomy tube kit), not an AI/software as a medical device. As such, the concepts of "device performance," "ground truth," "training set," "test set," "experts," "adjudication," or "MRMC studies" in the context of an AI algorithm's diagnostic or predictive capabilities are not relevant here.

Let's address the requests based on what is available in the provided text:

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

• Same intended use.
• Same technological characteristics (design, materials, manufacturing processes).
• Does not raise new safety or performance questions. | The proposed IYUNNI™ 3ID Tri-Funnel Feeding Tube Kit is presented as being the "same design, materials, and manufacturing processes of the predicate IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit (K092049)."
  "Testing has been performed and all components, subassemblies, and/or full devices met the specifications for the completed tests, including performance bench testing balloon inflation testing, and biocompatibility testing of the non-latex polyurethane film, which is the same material used in the predicate device."
  Conclusion states: "SaiNath Intellectual Properties, LLC has demonstrated that the proposed IYUNNI™ 3ID Tri-Funnel Feeding Tube Kit is substantially equivalent in intended use and indications to the predicate devices" and "Technological differences have been qualified through biomaterial assessments and bench testing, the result of which did not raise new safety or performance questions." |
  | Component Certification:
• Components are legally marketed pre-amendments, exempt from premarket notification, or found substantially equivalent through premarket notification. | The submitter certifies that the components of the kit are either legally marketed pre-amendments devices, exempt from premarket notification, or found to be substantially equivalent through the premarket notification process for their intended use. Specific mention is made that the kit includes a "currently marketed gastrostomy tube preassembled with a soft tip introducer dilator, which has been found substantially equivalent." |

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

• Not Applicable. This is a physical device submission, not an AI study involving a test set of data. The "testing" mentioned refers to bench testing and biocompatibility assessments, not clinical data sets.

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)

• Not Applicable. As this is not an AI device, there is no "ground truth" to be established by experts for a test set in the context of diagnostic or predictive performance.

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

• Not Applicable. No test set or adjudication method is described for this physical medical device.

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

• Not Applicable. This is not an AI device, and therefore, an MRMC study comparing human performance with and without AI assistance is not relevant or included.

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

• Not Applicable. As this is not an AI algorithm, a standalone performance study in that context is not relevant. The "performance data" refers to bench testing of the physical components.

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

• Not Applicable. There is no "ground truth" in the AI sense for this physical device. The "truth" in this context is whether the physical components meet their engineering specifications and perform as intended during bench testing, and whether the materials are biocompatible, as compared to the predicate device.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no AI model requiring a training set.

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

• Not Applicable. As there is no training set for an AI model, there's no ground truth to establish for it.

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