Search Results

The IYUNNI" 3ID Suprapubic Cystostomy Kit is indicated for use in suprapubic bladder catherization and drainage of fluids to and from the urinary tract.

The kit consists of two major components: IYUNNI™ Suprapubic Cystostomy Tube and IYUNNI™ Soft Collar Introducer Dilator. The kit is used for percutaneous bladder drainage.

The provided text describes the 510(k) summary for the IYUNNI™ 3ID Suprapubic Cystostomy Tube Kit. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific, quantitative acceptance criteria through a clinical study. Therefore, much of the requested information regarding detailed study design, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

Based on the available information, here's what can be extracted:

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

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

• Sample Size for Test Set: Not specified. The document states "Testing has been performed," implying bench testing rather than a clinical study with human subjects.
• Data Provenance: Not specified, but likely from laboratory/bench testing.

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. The "ground truth" here would pertain to engineering specifications and performance standards, likely evaluated by engineers or quality control personnel based on pre-defined test protocols, rather than medical experts establishing a "ground truth" for clinical outcomes.

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

• Not applicable. Adjudication methods are typically used in clinical studies for ambiguous cases or conflicting assessments, which is not described.

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 device is a medical catheter kit, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm or AI device. The phrase "standalone" as typically used in this context refers to AI performance.

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

• The "ground truth" would be established by engineering specifications, material standards, and functional performance requirements for the medical device. No clinical "ground truth" (like pathology or outcomes data) is mentioned as being used for performance evaluation in this context.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is not an AI or machine learning device. The "training" in manufacturing comes from established processes and quality control.

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

• Not applicable for the same reason as above.

Summary of the Study:

The provided text describes a 510(k) premarket notification for the IYUNNI™ 3ID Suprapubic Cystostomy Tube Kit. The "study" referenced is primarily a demonstration of substantial equivalence to already legally marketed predicate devices, rather than a clinical study to prove novel efficacy or safety with new performance metrics.

The document states: "Testing has been performed and all components, subassemblies, and/or full devices met the requires specifications for the completed tests." This indicates bench testing and biomaterial assessments were conducted to confirm that the new device's technological characteristics (design, materials, manufacturing processes) are similar to its predicates and do not raise new safety or performance questions. The conclusion explicitly states that "Technological differences have been qualified through biomaterial assessments and bench testing, the result of which did not raise new safety or performance questions."

Therefore, the "acceptance criteria" were likely the pre-defined engineering and material specifications for a suprapubic catheter kit, and the "study" was a series of in-vitro and bench tests to confirm adherence to these specifications and demonstrate equivalence to predicate devices regarding intended use, indications, and technological characteristics. No clinical trial data, human subject data, or AI performance metrics are presented or implied.

Ask a specific question about this device

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.

Ask a specific question about this device

The IYUNNI™ 3ID Tri-Funnel Gastrostomy 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, or using a Stamm Procedure. The gastrostomy tube may also be used for gastric decompression.

The IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit is a gastrostomy tube kit. The kit components include the IYUNNI™ Soft Tip Introducer Dilator.

The provided text describes a 510(k) premarket notification for a medical device and, as such, does not contain information about a study based on the criteria you've outlined for evaluating the performance of AI/ML-driven devices.

The document is for the IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit, which is a physical medical device (a gastrostomy tube), not a software or AI/ML diagnostic tool. Therefore, the concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "experts to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "training set sample size," or "how ground truth for training set was established" are not applicable in the context of this submission.

Instead, the submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. This is a regulatory pathway for lower-risk devices where the primary evidence of safety and effectiveness comes from showing that the new device has similar technological characteristics and performs comparably to a device already cleared by the FDA.

Here's how the provided information relates to the acceptance criteria for a physical medical device's 510(k) submission:

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

• Acceptance Criteria: For this type of device, "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity. Instead, acceptance is based on demonstrating substantial equivalence to predicate devices, meaning the new device is as safe and effective as the predicate. This is typically shown by comparing design, materials, indications for use, and performance characteristics (e.g., sterilization methods, packaging) to the predicate devices.
• Reported Device Performance: The document explicitly states: "The components of the IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit has the same characteristics as those devices that are currently marketed. There is no change in the performance characteristics or intended use." The performance is implicitly "equivalent to the predicate devices."

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. There is no "test set" in the sense of a dataset for algorithm evaluation. The evaluation is based on a comparison of device characteristics and intended use.

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

• Not applicable. There is no ground truth establishment for a diagnostic algorithm.

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

• Not applicable.

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-assisted diagnostic device.

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

• Not applicable.

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

• Not applicable.

8. The sample size for the training set:

• Not applicable.

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

• Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (a gastrostomy tube kit) and relies on demonstrating substantial equivalence to predicate devices rather than the types of performance studies and metrics that would be applicable to an AI/ML diagnostic or assistive device. The "acceptance criteria" are met by matching the safety and effectiveness profile of already cleared devices through design, material, and functional comparisons.

Ask a specific question about this device