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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.

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