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The Fossa Ureteral OPEN-8 Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder and to inhibit microbial adherence on the catheter, specifically Proteus Mirabilus and Escherichia Coli.

The Fossa Ureteral Open-8 Stent set consists of a flexible, piatail-tipped stent with a radiopaque push catheter. The stent is offered in various diameters and working lengths. The stent has two lumens open to the outside of the stent and two external grooves.

The provided text describes a 510(k) summary for the Fossa Ureteral OPEN-8 Stent. It states that "Product performance testing has been provided in support of this 510(k) in accordance with FDA's Guidance for the Content of Premarket Notifications for Ureteral Stents." However, the document does not include the specific acceptance criteria or the detailed results of the study demonstrating that the device meets those criteria.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's a summary of what can be inferred or directly stated from the provided text, and what is missing:

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

It also mentions: "TWE® materials used in the construction of the Fossa stent answere in other currently marketed uninary drainage devices."

The "Conclusion" states: "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the Fossa Ureteral OPEN-8 Stent have been shown to be safe and effective for its intended use."

Specifically related to a claim in the "Indications for Use": "...to inhibit microbial adherence on the catheter, specifically Proteus Mirabilus and Escherichia Coli." No performance data is provided to support this claim in the excerpt. |

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

• Not provided. The document does not describe the specific tests, study design, or sample sizes used.

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. This device is a ureteral stent, not an AI/imaging diagnostic device that requires expert ground truth for its performance evaluation in the way the question implies. The performance testing would likely involve benchtop or in-vivo animal/human studies focused on mechanical properties, biocompatibility, and functional aspects (drainage, microbial adherence).

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

• Not applicable. As above, this type of adjudication method is not relevant for the performance testing of a ureteral stent.

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

• No. This is not relevant for a ureteral stent. MRMC studies are typically for AI-assisted diagnostic tools.

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

• No. This is not relevant. The device is a physical medical implant, not an algorithm.

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

• Not explicitly stated in the provided text. For a ureteral stent, "ground truth" would relate to whether the device successfully drains urine, prevents microbial adhesion, and remains functional without complications. This would likely be assessed through methods such as:
  • Mechanical testing: Benchtop tests for flexibility, tensile strength, crushing resistance, flow rates.
  • Biocompatibility testing: In vitro and/or in vivo studies to ensure material safety.
  • Microbial adherence studies: In vitro tests specifically for Proteus Mirabilus and Escherichia Coli as claimed.
  • Clinical outcomes data: (If human studies were conducted, which is not detailed here), observing drainage, patency, encrustation, infection rates.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would have a "training set."

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

• Not applicable. This is not an AI/machine learning device.

In summary: The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices and broadly states that performance testing was conducted according to FDA guidance. It does not provide the specific details of the performance tests, acceptance criteria, or the study results themselves. These details would typically be found in the full 510(k) submission, which is more comprehensive than the summary provided here.

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